Transforming neonatal nursing: a randomized controlled trial comparing kangaroo care and standard protocols for survival in preterm infants with respiratory distress syndrome

Abstract

Background

Respiratory Distress Syndrome (RDS) remains a leading cause of mortality among preterm infants weighing < 2000 g, particularly in resource-limited settings. While Kangaroo Mother Care (KMC) has shown promise in stable preterm infants, its effectiveness for those requiring respiratory support remains unclear. This study evaluated nurse-led implementation of KMC for preterm infants with RDS.

Methods

A prospective, multicenter, randomized controlled trial was conducted across four neonatal intensive care units in Tanta, Egypt (January 2023–June 2024). Two hundred forty preterm infants (<2000 g) with RDS were randomly assigned to either nurse-implemented KMC (n = 120) or standard care (n = 120). The KMC protocol, implemented for a minimum of 6 h per day until hospital discharge, integrated continuous skin-to-skin contact, exclusive breastfeeding promotion, and structured parental education. Outcomes included 28-day survival, respiratory status (Silverman-Anderson Scores), nosocomial infections, maternal-infant bonding, growth trajectories, and clinical course metrics.

Results

The KMC intervention significantly improved 28-day survival (adjusted HR = 0.42, 95% CI 0.28–0.63, p < 0.001) and reduced nosocomial infections by 55% (RR = 0.45, 95% CI 0.27–0.75, p < 0.001). KMC recipients demonstrated faster respiratory improvement, shorter CPAP duration (−2.2 days, p < 0.001), and higher rates of exclusive breastfeeding at discharge (74.2% vs. 48.3%, p < 0.001). Maternal competency scores showed progressive improvement with enhanced bonding and responsiveness.

Conclusion

Nurse-implemented KMC is a safe, effective intervention for preterm infants with RDS, yielding significant improvements in survival, clinical outcomes, and family-centered care metrics.

Implications for practice

These findings support the expansion of nursing roles in implementing KMC for high-risk infants in resource-limited settings.

Trial registration

ClinicalTrials.gov (NCT06707376).

Introduction

Preterm birth remains a global health challenge, accounting for over 15 million births annually and more than one million neonatal deaths [1, 2]. Among these, preterm infants weighing < 2000 g face the greatest risks of complications, including Respiratory Distress Syndrome (RDS), which is a leading cause of neonatal mortality [3, 4]. RDS results from surfactant deficiency and immature lung development, leading to alveolar collapse, impaired gas exchange, and progressive respiratory failure [5]. The condition affects approximately 60–80% of infants born before 28 weeks of gestation [6, 7]. In Egypt, where the preterm birth rate is estimated at 13%, neonatal mortality remains alarmingly high due to limited access to advanced respiratory interventions such as surfactant therapy and mechanical ventilation [8,9,10].

Standard neonatal care for RDS typically includes Continuous Positive Airway Pressure (CPAP), mechanical ventilation, and surfactant replacement therapy [11]. While these interventions have significantly improved survival rates in high-resource settings, they are costly, resource-intensive, and often inaccessible in low- and middle-income countries (LMICs) [12, 13]. In Egypt, neonatal units frequently lack the infrastructure, equipment, and trained staff necessary to provide these therapies effectively [14, 15]. Additionally, standard neonatal care protocols often separate preterm infants from their mothers, disrupting maternal-infant bonding, delaying breastfeeding initiation, and increasing the risk of nosocomial infections [16, 17]. These limitations underscore the urgent need for cost-effective, scalable, and family-centered care strategies in LMICs [18].

Kangaroo Mother Care (KMC) has emerged as a transformative approach to neonatal care, particularly in resource-limited settings [19]. KMC involves continuous skin-to-skin contact, exclusive breastfeeding, and early discharge with follow-up [20,21,22]. Physiologically, it stabilizes vital signs, supports thermoregulation, enhances oxygenation, and reduces metabolic stress [23]. Psychosocially, KMC fosters maternal-infant bonding, reduces parental anxiety, and promotes family-centered care models [24, 25]. Globally, KMC has demonstrated a 36% reduction in neonatal mortality, a 47% decrease in severe infections, and a 78% reduction in hypothermia [24, 25]. However, most studies focus on stable preterm infants without severe complications [26, 27], leaving a critical gap in evaluating its safety, feasibility, and effectiveness in high-risk populations, such as preterm infants with RDS requiring respiratory support [27].

Nurses are at the forefront of neonatal care and play an essential role in the successful implementation of KMC, particularly in LMICs like Egypt [28]. Their responsibilities extend beyond routine clinical tasks to encompass parent education on the physiological and psychosocial benefits of KMC, including thermoregulation, bonding, and breastfeeding [29]. Nurses’ ability to create a supportive environment for parents while managing the unique needs of high-risk preterm infants is vital for ensuring adherence to KMC protocols [30]. Furthermore, their clinical expertise allows them to monitor the safety of KMC in infants receiving CPAP or mechanical ventilation, tailoring care to the infants’ specific needs [31]. Beyond direct care, nurses are key advocates for integrating KMC into hospital policies, training programs, and workflow protocols [25]. Their leadership in promoting family-centered care improves neonatal outcomes and addresses systemic challenges in LMICs by fostering collaboration, innovation, and sustainable practice models [32]. By empowering nurses through training and policy support, KMC has the potential to revolutionize neonatal nursing practices and enhance the quality of care [33].

Background

Respiratory Distress Syndrome is one of the leading causes of neonatal morbidity and mortality, with approximately 2.9 million cases reported annually [34, 35]. RDS is primarily caused by a deficiency in pulmonary surfactant, a critical substance that reduces alveolar surface tension and prevents lung collapse [36]. Without timely intervention, RDS rapidly progresses to hypoxemia, respiratory failure, and death [37, 38]. Advances in neonatal care have reduced RDS-related mortality to about 20% in high-income countries [39]. However, in LMICs like Egypt, where access to respiratory support and surfactant therapy is limited, mortality rates can exceed 50% [40]. This disparity highlights the need for innovative approaches such as KMC, which addresses both physiological needs and systemic limitations in neonatal care [28].

KMC was initially developed in Colombia as a response to overcrowded neonatal units and limited access to incubators [41, 42]. Beyond its practical origins, KMC has gained international recognition for its multifaceted benefits. Skin-to-skin contact facilitates thermoregulation, preventing hypothermia, a leading cause of mortality in preterm infants [43]. Exclusive breastfeeding, another cornerstone of KMC, provides optimal nutrition and immunological protection, significantly reducing the risk of sepsis and malnutrition [44, 45]. The psychosocial benefits of KMC, including enhanced maternal confidence and reduced parental stress, further support its role as a holistic approach to neonatal care [44, 45]. Despite these advantages, its application in high-risk populations, such as preterm infants with RDS, remains underexplored [46]. Concerns about maintaining skin-to-skin contact alongside respiratory support and the lack of robust evidence from randomized controlled trials (RCTs) contribute to its limited adoption in this subgroup [47].

The benefits of KMC are grounded in robust theoretical frameworks that combine physiological and psychosocial mechanisms. The Thermoregulatory Control Hypothesis explains how skin-to-skin contact stabilizes the infant’s temperature through maternal heat transfer, reducing metabolic stress and promoting energy conservation [48]. The Proximity and Bonding Theory highlights the psychological advantages of close maternal-infant contact, which enhances caregiving behaviors, reduces stress, and promotes exclusive breastfeeding [49]. Additionally, KMC aligns with the principles of Developmental Care Models, which prioritize minimizing invasive interventions and fostering an environment conducive to optimal neurodevelopment in preterm infants [50]. These theoretical underpinnings support the rationale for investigating KMC as an intervention for high-risk preterm infants with RDS, addressing their unique vulnerabilities to thermal instability, infections, and feeding difficulties [51, 52].

The integration of KMC into clinical settings, particularly in resource-limited environments like Egypt, presents both challenges and opportunities [27, 36, 53]. Barriers include skepticism among healthcare providers regarding its feasibility for infants on CPAP or mechanical ventilation, inadequate training on KMC techniques, and cultural misconceptions about maternal-infant contact [20, 21]. Additionally, resource constraints, such as overcrowded neonatal units and insufficient breastfeeding support, limit its widespread adoption [22]. However, facilitators such as national policy endorsements, targeted training for healthcare providers, and community-based education initiatives can drive acceptance and ensure sustained implementation [24, 25]. Pilot programs demonstrating KMC’s safety and efficacy in real-world settings provide valuable evidence to address resistance and inform broader policy integration [19]. A phased implementation strategy, beginning with stable preterm infants and supported by infrastructure investments and monitoring systems, can further embed KMC into routine neonatal care practices [45].

This study aimed to evaluate the effectiveness of Kangaroo Mother Care (KMC) compared to standard neonatal care protocols in improving survival outcomes among preterm infants (<2000 g) diagnosed with Respiratory Distress Syndrome (RDS) in neonatal units in Tanta, Egypt. The study sought to address the applicability of KMC as an evidence-based, family-centered care intervention for high-risk neonatal populations in resource-constrained settings.

Research objectives

• 1. To assess whether Kangaroo Mother Care improves survival rates among preterm infants diagnosed with RDS compared to those receiving standard neonatal care protocols.

• 2. To evaluate the duration and intensity of respiratory support, including CPAP or mechanical ventilation, required for preterm infants in both the KMC and standard care groups.

• 3. To analyze weight gain and growth trajectories during hospitalization in infants receiving KMC versus standard care.

• 4. To compare the incidence of nosocomial infections and other neonatal complications between the KMC and standard care groups.

• 5. To assess breastfeeding initiation and continuation rates and their association with the use of KMC.

• 6. To compare the length of hospital stay between infants receiving KMC and those managed with standard neonatal care protocols.

Research hypotheses

• 1. Preterm infants (<2000 g) with RDS receiving Kangaroo Mother Care will demonstrate significantly higher survival rates compared to those receiving standard neonatal care protocols.

• 2. KMC will reduce the duration and intensity of respiratory support required compared to standard neonatal care.

• 3. Infants receiving KMC will have a lower incidence of nosocomial infections compared to those in the standard care group.

• 4. KMC will result in greater weight gain and improved growth metrics during hospitalization compared to standard care.

• 5. KMC will lead to higher rates of breastfeeding initiation and continuation compared to standard neonatal care protocols.

• 6. KMC will result in a shorter hospital stay than standard neonatal care.

This study provides essential evidence on the feasibility and effectiveness of KMC for preterm infants with RDS in Egypt, addressing a critical gap in neonatal care research. By integrating nurses as pivotal change agents, the study underscores their role in educating parents, monitoring clinical outcomes, and advocating for systemic integration of KMC protocols. The findings offer actionable strategies to overcome barriers in resource-limited settings, such as training deficits and cultural misconceptions, while leveraging facilitators like policy endorsements and family-centered care models. This research advances the understanding of KMC’s transformative potential and highlights its implications for neonatal nursing by promoting evidence-based practices, enhancing professional competencies, and fostering equity in neonatal care. By demonstrating KMC’s ability to improve survival outcomes and reduce healthcare disparities, this study has the potential to inform clinical guidelines, shape healthcare policies, and redefine neonatal nursing practices globally.

Materials and methods

Design

This study utilized a prospective, parallel-group, randomized controlled trial (RCT) design to compare the effectiveness of Kangaroo Mother Care (KMC) with standard neonatal care protocols [54]. The RCT design was selected as it is the gold standard for establishing causal relationships and minimizing bias, making it highly appropriate for evaluating interventions in vulnerable populations such as preterm infants [55]. Stratified randomization was implemented to ensure balanced allocation across key prognostic factors, including gestational age (28–31 weeks; 32–34 weeks) and birth weight categories (1000–1499 g; 1500–1999 g). Randomization sequences were generated using SAS version 9.4, with variable block sizes (4, 6, and 8) to maintain allocation unpredictability while ensuring group balance. Allocation concealment was ensured through the use of sequentially numbered, opaque, sealed envelopes prepared and managed by an independent research coordinator to minimize selection bias [56]. Complete blinding of participants and caregivers was not feasible due to the nature of the KMC intervention. However, outcome assessors and data analysts remained blinded to group assignments to reduce detection and reporting biases [57]. Trained neonatal nurses, independent of the intervention team, served as data collectors. They received standardized training on data collection procedures, including the assessment of respiratory status, feeding patterns, and maternal-infant bonding, to ensure accuracy and consistency. Regular inter-rater reliability checks were conducted to maintain data quality and minimize observer bias. The study followed the Consolidated Standards of Reporting Trials (CONSORT) guidelines to ensure methodological rigor, ethical compliance, and transparent reporting [58].

Study setting and sampling

This multi-center randomized controlled trial was conducted across four neonatal intensive care units (NICUs) in Tanta, Egypt, from January 2023 to June 2024. To enhance the study’s external validity, the participating NICUs were strategically selected to represent diverse healthcare delivery systems, including tertiary referral centers, general hospitals, and district-level facilities. These NICUs varied in infrastructure and resource availability, with incubator capacities ranging from 12 to 45 and nursing teams of 50–70 staff members. This selection ensured the inclusion of different neonatal care environments, allowing for a comprehensive evaluation of Kangaroo Mother Care (KMC) across various levels of clinical practice and resource constraints. Sample size determination was conducted using G*Power 3.1.9.4 software. Parameters included a significance level (α) of 0.05, power (1-β) of 0.80, and an anticipated medium effect size (Cohen’s d = 0.40) derived from prior studies on Kangaroo Mother Care (KMC) interventions [29,30,31]. Based on these inputs, the initial calculation indicated a requirement of 200 participants. The presence of a mother or another caregiver who was willing to provide the intervention was also required. To account for an expected 20% attrition rate due to mortality and potential loss to follow-up, the final target sample size was adjusted to 240 preterm infants, evenly distributed between the intervention and control groups. Participant recruitment occurred over 12 months (January–December 2023), with follow-up extending through June 2024.

Inclusion and exclusion criteria

Inclusion criteria

Eligible participants included preterm infants with a birth weight of < 2000 g who were diagnosed with Respiratory Distress Syndrome (RDS) based on standardized clinical and radiological criteria. Infants had to be admitted to the NICU within 24 h of birth and demonstrate hemodynamic stability with minimal respiratory support requirements, such as low-flow oxygen or continuous positive airway pressure (CPAP). Written informed parental consent was mandatory for enrollment.

Exclusion criteria

Exclusion criteria included neonates with major congenital anomalies incompatible with life, severe perinatal asphyxia defined by an Apgar score of < 3 at 5 min, and severe hemodynamic or respiratory instability requiring high-frequency ventilation. Multiple births were excluded if not all infants met inclusion criteria, and neonates transferred from other facilities after 24 h of birth were not eligible. Parents unable to commit to the intervention protocol or follow-up schedule were also excluded.

Based on the specified inclusion and exclusion criteria, a total of 300 preterm infants were assessed for eligibility during the recruitment period. Of these, 60 infants were excluded: 25 did not meet the inclusion criteria (e.g., birth weight above 2000 g or severe respiratory instability), 20 were excluded due to congenital anomalies incompatible with life, and 15 parents declined to provide consent. The remaining 240 eligible infants were randomly allocated equally into the intervention group (n = 120) and the control group (n = 120). All participants in the intervention group received Kangaroo Mother Care (KMC) according to the study protocol, while those in the control group received standard NICU care. At enrollment, comprehensive baseline data were collected for all participants. This included infant characteristics (sex, gestational age, birth weight), maternal demographic and clinical data (age, parity, presence of hypertension), and initial clinical parameters. Clinical assessment included the Silverman-Anderson Score (SAS), Apgar scores, and documentation of respiratory support modality (room air, low-flow oxygen, or CPAP). These baseline characteristics were recorded using standardized forms to ensure consistent data collection across all participating sites. During the study period, there were no losses to follow-up or withdrawals in either group, ensuring complete data collection and analysis for all participants. The flow diagram in Fig. 1 provides a detailed depiction of the enrollment process, randomization, intervention implementation, and follow-up phases. This transparent reporting aligns with CONSORT 2010 guidelines and ensures clarity in participant flow, enhancing the reproducibility and integrity of the study. The study protocol has been registered with ClinicalTrials.gov (Identifier: NCT06707376).

Fig. 1

Study flowchart

Instruments

This study employed six validated instruments meticulously selected to measure both the implementation and outcomes of Kangaroo Mother Care (KMC) in preterm infants diagnosed with Respiratory Distress Syndrome (RDS). These instruments ensure comprehensive data collection aligned with the research objectives, maintaining methodological rigor and data accuracy throughout the study.

The Baseline Data Collection Form (BDCF) was developed and validated to ensure systematic documentation of comprehensive participant information. This 47-item structured instrument encompasses three domains: infant characteristics (15 items including demographics, birth history, and initial clinical status), maternal characteristics (12 items covering demographics, obstetric history, and medical conditions), and clinical course documentation (20 items tracking vital signs, interventions, and outcomes). The BDCF underwent rigorous content validation by a panel of five neonatal experts (Content Validity Index = 0.92) and demonstrated excellent inter-rater reliability (κ = 0.89) during pilot testing with 20 mother-infant dyads across participating NICUs. To maintain data quality, all research nurses completed standardized training and participated in monthly reliability assessments (minimum acceptable coefficient = 0.85). The form was integrated into the electronic health record system to facilitate real-time data verification and reduce missing data, with automated logic checks ensuring data consistency and completeness.

The World Health Organization Kangaroo Mother Care Assessment Tool (WHO-KMC-AT) was used to evaluate protocol implementation and adherence. Developed by the World Health Organization, the WHO-KMC-AT comprises three components: a 15-item KMC Practice Score, a 10-item Maternal Competency Scale, and a 20-item Implementation Checklist [51, 59]. The KMC Practice Score assesses essential practices such as infant positioning, duration of skin-to-skin contact, and adherence to KMC techniques. The Maternal Competency Scale evaluates caregivers’ knowledge and skills related to KMC, while the Implementation Checklist monitors protocol fidelity and institutional adherence to KMC guidelines. Each item is scored on a 4-point Likert scale, with higher scores indicating better adherence and competency [60]. The WHO-KMC-AT has demonstrated strong internal consistency (Cronbach’s α = 0.87) [61]. It has been validated in Egyptian NICU settings through pilot testing and expert review, ensuring its relevance and applicability within the study context [62, 63].

Respiratory assessment was conducted using the Silverman-Anderson Respiratory Severity Score (SAS), a validated tool designed to evaluate respiratory distress in preterm infants [64, 65]. Developed by Silverman and Anderson, the SAS evaluates five components: chest retractions, intercostal retractions, xiphoid retractions, nasal flaring, and grunting [64]. Each component is scored from 0 (absent) to 2 (severe), yielding a total score ranging from 0 to 10. Higher scores indicate increased respiratory distress [66]. In previous studies, the SAS has shown excellent inter-rater reliability (κ = 0.85) and was administered by trained nurses at standardized intervals throughout the intervention period [67,68,69]. This instrument facilitated monitoring changes in respiratory status and the assessment of the necessity for additional respiratory support.

Growth monitoring followed the World Health Organization (WHO) Standards for Preterm Growth Assessment protocol [70]. This standardized tool includes daily weight measurements using calibrated electronic scales with an accuracy of ± 1 g, weekly crown-heel length measurements using a standardized infantometer accurate to ± 0.1 cm, and head circumference measurements using non-stretchable measuring tapes accurate to ± 0.1 cm [71]. All measurements were conducted following WHO’s standardized operating procedures and documented on preterm-specific growth charts (WHO Preterm Growth Charts, 2016) [72]. This rigorous approach ensures precise and consistent weight gain, length, and head circumference assessment, aligning with the study’s hypothesis that KMC promotes superior growth outcomes compared to standard care.

The Mother-Infant Bonding Tool (MIBT) was employed to evaluate maternal-infant bonding and caregiver competency [73]. Validated for use in KMC research, the MIBT is a 25-item observational instrument that assesses both technical aspects of KMC delivery, such as proper positioning and vital sign monitoring, and psychosocial components of care, including maternal confidence and responsiveness [74, 75]. Each item is rated on a 5-point Likert scale, with higher scores indicating stronger bonding and greater competency. The MIBT has demonstrated strong reliability (Cronbach’s α = 0.88) and construct validity in previous KMC studies [75, 76]. Assessments were conducted at baseline, mid-intervention, and post-intervention to measure changes in bonding and competency attributable to KMC, providing comprehensive data on educational outcomes and support effectiveness.

Clinical outcomes were monitored using the Neonatal Morbidity Assessment Tool (NMAT), which systematically documents infection rates, respiratory support requirements, and length of hospital stay [77, 78]. Developed based on Centers for Disease Control and Prevention (CDC) guidelines for nosocomial infection surveillance, the NMAT captures detailed information on the type of infection (e.g., sepsis, pneumonia, urinary tract infections), onset and duration relative to NICU admission and treatment outcomes, including antibiotic use and resolution of infection [78, 79]. Additionally, the NMAT records respiratory support parameters and clinical complications. This standardized tool has been validated for use in NICU settings and demonstrates high inter-rater reliability (κ = 0.87), ensuring accurate and consistent documentation of clinical outcomes across all study sites [80].

All instruments underwent rigorous translation into Arabic using the World Health Organization’s forward-backward translation protocol to ensure linguistic and cultural relevance. Pilot testing was conducted with 20 mother-infant dyads at each participating NICU to assess clarity and applicability, resulting in minor adjustments to enhance comprehension and usability. Comprehensive training sessions for all data collectors emphasized standardized administration procedures for each instrument. Regular inter-rater reliability assessments were conducted monthly, maintaining a minimum reliability coefficient of 0.85 for all observational and assessment tools. Data collection forms were standardized across sites, and electronic verification procedures were incorporated to ensure completeness and accuracy.

Intervention protocol and implementation framework

Protocol development and clinical standardization

The intervention framework was developed through a consensus-driven process involving senior neonatal nurses and neonatologists from participating Neonatal Intensive Care Units (NICUs). Three key elements Kangaroo Mother Care (KMC) implementation, clinical monitoring parameters, and family education were prioritized to address both clinical and psychosocial dimensions of preterm infant care. An independent panel of neonatal specialists, research methodologists, and clinical epidemiologists externally validated the resulting protocol, ensuring alignment with international KMC guidelines and local resource constraints.

Evidence-based thresholds were established to define clinical stability for both the intervention and control groups. These included an oxygen saturation range of 88–95% on minimal respiratory support, a heart rate of 100–160 beats per minute, a respiratory rate of 30–60 breaths per minute, and an axillary temperature of 36.5–37.5 °C maintained consistently for at least 24 h before enrollment. All study sites used calibrated multiparameter physiological monitors to ensure uniform data collection of vital parameters. These criteria safeguarded participant safety and standardized enrollment procedures across diverse NICU settings. Figure 2 depicts the clinical stability assessment algorithm guiding decisions on KMC eligibility.

Fig. 2

Clinical algorithm for KMC eligibility assessment in preterm infants with RDS: standardized stability parameters

Randomization, allocation, and blinding mechanisms

Participants confirmed to meet the stability criteria were randomized into either the KMC (intervention) or standard care (control) group using a computer-generated sequence stratified by site. Block randomization was applied to ensure equal group sizes. Allocation concealment was achieved by means of sequentially numbered, opaque, sealed envelopes prepared by an independent researcher, which site coordinators opened in strict order at the time of enrollment. Blinding protocols were implemented to preserve methodological rigor. While complete blinding of caregivers was not feasible due to the nature of KMC, participants were informed that both arms represented critical neonatal care strategies without disclosing the specific hypothesis. Data collectors and outcome assessors operated independently from the KMC training staff, thus remaining blinded to group assignments. This separation minimized detection and reporting biases. Periodic audits, conducted by external clinical researchers, further verified adherence to randomization and blinding protocols, ensuring data integrity across all sites.

Intervention Group (KMC)

Infants in the intervention arm received a structured KMC protocol focusing on thermoregulation, enhanced maternal-infant bonding, and promotion of exclusive breastfeeding. The protocol was initially planned for the first seven days but was extended as needed until the infant’s discharge if clinically indicated.

Session 1: Orientation (Day 1)

• Caregivers attended a two-hour workshop led by KMC-certified nurses, covering essential KMC principles, correct infant positioning, safe wrapping techniques, and basic vital sign checks.

• Guidelines for promptly detecting clinical instability were emphasized. This included systematic observation of respiratory effort, using the Silverman-Anderson Respiratory Severity Score (SAS) (Section 3.4), and temperature monitoring.

Session 2: Daily Bedside Coaching (Day 2–Day 7 or Until Discharge)

• Caregivers received one-on-one, 30-min coaching sessions each day, integrating routine care (feeding, diaper changes) with uninterrupted skin-to-skin contact.

• Nurses utilized the World Health Organization Kangaroo Mother Care Assessment Tool (WHO-KMC-AT) to evaluate adherence to KMC techniques, maternal competencies, and protocol fidelity. Data on infant vital signs were captured concurrently to gauge stability.

Session 3: Weekly Support Group Meetings (Every 7 Days)

• Facilitated by neonatal specialists, these sessions reinforced exclusive breastfeeding, psychosocial support, and problem-solving strategies for challenges encountered (e.g., infant positioning difficulties).

• The Mother-Infant Bonding Tool (MIBT) was administered at these meetings to document maternal confidence, responsiveness, and bonding quality, aligning with the study’s emphasis on psychosocial outcomes.

Session 4: Pre-Discharge Competency Assessment (Prior to NICU Discharge)

• Caregivers demonstrated their skill in maintaining effective KMC, monitoring vital signs, and recognizing warning signs such as abnormal temperature or elevated SAS scores.

• Final measurements using the WHO-KMC-AT and MIBT captured competency levels at discharge. Concurrently, growth metrics (e.g., daily weight, weekly length, and head circumference) were recorded in accordance with WHO Standards for Preterm Growth Assessment (Sect. 3.4).

• Any episodes of nosocomial infection or respiratory complications were tracked using the Neonatal Morbidity Assessment Tool (NMAT) to provide comprehensive clinical outcome data.

Control Group (Standard Care)

Infants in the control arm received routine NICU care, structured to parallel the intervention’s schedule for equitable caregiver engagement and data collection.

Session 1: Standard Orientation (Day 1)

• Caregivers participated in a one-hour briefing, covering general NICU policies, thermoregulation, feeding support, and baseline developmental care practices.

Session 2: Daily Care Interactions (Day 2–Day 7 or Until Discharge)

• Caregivers were encouraged to partake in typical infant care activities (feeding, diaper changes, comforting) during standard visiting hours.

• Ongoing assessments of respiratory status were conducted using the SAS, mirroring the KMC group’s practice for consistency. Growth parameters were similarly monitored as per WHO standards.

Session 3: Weekly Support Sessions (Every 7 Days)

• Group discussions focused on addressing routine NICU challenges, discharge planning, and reinforcing infection prevention measures.

• Although skin-to-skin contact was not mandated, caregivers could hold infants as permitted by standard unit protocols.

Session 4: Pre-Discharge Instructions (Before NICU Discharge)

• Caregivers received individualized education on safe infant handling, early warning signs of clinical deterioration, and appropriate follow-up care.

• As with the intervention group, final respiratory (SAS), growth (WHO Growth Charts), and clinical data (NMAT) were documented at discharge to facilitate outcome comparisons.

Integrated training, quality assurance, and data management

All neonatal nurses involved underwent a 40-h KMC certification program focusing on theoretical underpinnings, practical demonstrations, and accurate data documentation. Monthly reliability checks and inter-rater assessments ensured consistent administration of the WHO-KMC-AT, SAS, MIBT, NMAT, and WHO growth protocols. Real-time data were electronically recorded to facilitate immediate clinical review and maintain robust documentation of adherence, infant stability, and adverse events. Weekly internal reviews were complemented by quarterly external audits conducted by independent clinical researchers, enhancing the reliability of study findings. Data handling conformed to Good Clinical Practice guidelines, with secure, encrypted databases employed for storage and analysis.

Data collection and follow-up

A structured schedule of data collection was established to comprehensively capture both in-hospital and post-discharge outcomes. At baseline (Day 1), prior to randomization and NICU admission, relevant demographic and clinical data were recorded using the validated Baseline Data Collection Form (BDCF). This standardized form captured infant characteristics (demographics, birth history, initial clinical status), maternal characteristics (demographics, obstetric and medical history), and baseline clinical parameters, ensuring systematic documentation across all study sites. During the in-hospital phase, assessments were conducted at 24 h, Day 3, Day 7, Day 14, Day 21, and at pre-discharge (whenever that occurred after Day 7). Trained neonatal nurses documented respiratory status using the Silverman-Anderson Score, monitored growth metrics (weight, length, head circumference), evaluated maternal-infant bonding through the Mother-Infant Bonding Tool, and tracked adherence to Kangaroo Mother Care via the WHO-KMC-AT. In addition, the Neonatal Morbidity Assessment Tool (NMAT) was administered daily to log infections, antibiotic use, apnea episodes, and feeding intolerance throughout the NICU stay.

For post-discharge follow-up, infants were observed for up to 28 days to assess readmission, mortality, and breastfeeding status. Parents or legal guardians received a standardized phone call or attended outpatient clinic visits at approximately 2 weeks and 4 weeks post-discharge. A dedicated research nurse administered a brief checklist to ascertain any hospital readmissions, confirm ongoing feeding practices, and document newly occurring illnesses or complications. Mortality events occurring outside the hospital setting within 28 days of discharge were likewise documented, based on direct family reporting or verification through hospital records.

Operational definitions for key outcomes

28-Day Survival: Survival from birth to 28 days of life. Any infant death occurring before or at 28 days (in-hospital or following discharge) was recorded as a mortality event.

Infection-Free Survival: Defined as the absence of a nosocomial infection based on CDC criteria (e.g., sepsis, pneumonia, or NEC) from the time of randomization until discharge. After discharge, any infection-related hospital readmission during the 28-day follow-up window was also captured.

Early Discharge: Discharge from the NICU before Day 21 of life, provided the infant met clinical stability criteria (i.e., maintaining adequate temperature, feeding, respiratory status) with no unresolved complications.

Readmission: Any hospitalization in a healthcare facility within 28 days post-discharge for reasons related to neonatal health, as confirmed by parent report and verified when possible through hospital records.

Exclusive Breastfeeding: No supplementary feeding with formula, water, or other liquids/foods, except for expressed maternal breast milk. At baseline, caregivers were instructed on exclusive breastfeeding practices. At each follow-up point (in-hospital and post-discharge), a standardized item in the data collection form verified ongoing exclusivity.

All follow-up data were aggregated into a secure, encrypted database, with each infant assigned a unique study identifier. In cases where the family could not be reached by phone, clinic appointments were encouraged, and alternative contacts listed at enrollment were utilized.

Ethics approval

This study adhered to the principles outlined in the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval was granted by the Ethical Committee of the Faculty of Nursing, Tanta University (Approval No. 547), and the study was registered with ClinicalTrials.gov (Identifier: NCT06707376) to ensure transparency and compliance with international standards. Written informed consent was obtained from both parents or legal guardians before enrollment, with information provided in Arabic to ensure clarity. Confidentiality was maintained through the use of unique identifiers and encrypted data storage systems, accessible only to authorized research personnel. Given the vulnerability of preterm infants, additional safeguards were implemented, including daily safety assessments, predefined clinical stopping criteria, dedicated staff monitoring during initial Kangaroo Mother Care (KMC) sessions, and emergency response protocols. An independent Data Safety Monitoring Board conducted monthly reviews of adverse events and protocol adherence, while regular site audits ensured proper implementation of all safety measures and compliance with the approved protocol.

Statistical analysis

The statistical analysis was conducted using SPSS version 28. Continuous variables were summarized as mean (standard deviation), and categorical variables were presented as counts and percentages. Baseline equivalence between the Kangaroo Mother Care (KMC) and Standard Care groups was assessed using independent Student’s t-tests for continuous variables and Chi-square tests for categorical variables, with effect sizes reported as Cohen’s d or Cramer’s V as appropriate. Repeated measures analyses, including longitudinal outcomes, were evaluated using linear mixed-effects models to account for within-subject correlations over time, with Bonferroni corrections applied for multiple comparisons. The primary outcome measures, such as changes in the Silverman-Anderson Scores (SAS) over time, were analyzed using mixed-model ANOVA to assess main effects (time, group) and interaction effects (time × group), with partial eta squared (η²) reported as a measure of effect size. Multivariable Cox proportional hazards regression was employed to estimate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for survival outcomes.

Logistic regression was used for binary outcomes, including 28-day survival, infection-free survival, and early discharge success, with adjusted odds ratios (ORs) and area under the receiver operating characteristic curve (AUC) provided to evaluate model discrimination. Continuous outcomes, such as hospital length of stay, were analyzed using linear regression with robust standard errors to control for clustering by study site. Multicollinearity was assessed through variance inflation factors (VIF), ensuring all variables met the threshold of VIF < 3. Model diagnostics included testing for proportional hazards assumptions for the Cox model, non-significant Hosmer-Lemeshow tests for logistic regression, and residual plot examination for linear regression to confirm adherence to statistical assumptions. Missing data were minimal (<3%) and addressed using pairwise deletion methods, ensuring sufficient statistical power. Significance was defined as p < 0.05, with adjustments made for multiple testing where applicable. Effect sizes (e.g., Cohen’s d, η², and standardized β coefficients) and CIs were reported to provide comprehensive measures of statistical and clinical relevance.

Results

Table 1 establishes the baseline equivalence of the Kangaroo Mother Care (KMC) and Standard Care groups, demonstrating balanced distributions across key infant, maternal, and clinical characteristics. Mean gestational age (32.1 ± 1.5 vs. 32.0 ± 1.6 weeks, p = 0.71) and birth weight (1450.2 ± 135.3 g vs. 1448.3 ± 137.6 g, p = 0.85) were similar, with standardized differences below 0.05, indicating no significant disparities in these critical prognostic factors. Clinical measures, including baseline Silverman-Anderson Scores (4.2 ± 1.0 vs. 4.3 ± 0.9, p = 0.63) and Apgar scores at 5 min (7.5 ± 1.2 vs. 7.4 ± 1.3, p = 0.68), confirm comparable neonatal stability at enrollment. Vital signs demonstrated similar physiological stability between groups, with temperature (36.8 ± 0.3 °C vs. 36.7 ± 0.4 °C, p = 0.12), heart rate (142.5 ± 12.3 vs. 143.2 ± 11.8 beats/min, p = 0.77), and oxygen saturation (92.5 ± 2.8% vs. 92.3 ± 2.9%, p = 0.75) all within normal ranges. Initial therapeutic interventions were also comparable, with similar rates of antibiotic administration (87.5% vs. 88.3%, p = 0.85) and intravenous fluid therapy (89.2% vs. 83.3%, p = 0.18). Additionally, initial respiratory support requirements were closely aligned between groups, with no significant differences in the proportions requiring CPAP (39.2% vs. 40.0%, p = 0.91), low-flow oxygen (45.8% vs. 43.3%, p = 0.75), or room air-only support (15.0% vs. 16.7%, p = 0.84). Minimal missing data (≤2.5%) and precise effect size reporting, supported by narrow 95% confidence intervals, reinforce the table’s methodological strength. The inclusion of detailed stratification for gestational age, birth weight categories, and maternal risk factors enhances clinical relevance, ensuring a robust foundation for evaluating intervention outcomes without bias introduced by baseline imbalances.

Table 1 Baseline demographic and clinical characteristics of study participants

Table 2 demonstrates a significant and clinically meaningful improvement in respiratory status, as measured by the Silverman-Anderson score (SAS), in the Kangaroo Mother Care (KMC) group compared to Standard Care. At all post-baseline time points, the KMC group showed progressively greater reductions in SAS scores, culminating in substantial differences by Day 7 and pre-discharge (mean difference: − 0.9, 95% CI [−1.08, − 0.72] and − 0.9, 95% CI [−1.06, − 0.74], respectively; both p < 0.001). The large effect sizes (Cohen’s d: 1.38–1.65) underscore the substantial clinical impact of KMC in reducing respiratory distress. The significant time × group interaction effect (F = 42.75, p < 0.001, partial η² = 0.15) confirms a steeper trajectory of respiratory improvement in the KMC group, further supported by the high partial η² for time effects (0.51). The minimal missing data (<3%) ensures robust statistical power, reinforcing the validity of these findings. These results highlight the potential of KMC as an effective, low-cost intervention for improving respiratory outcomes in preterm infants, particularly in resource-limited settings.

Table 2 Inter-group comparison of respiratory status over time (Silverman-Anderson scores)

The analysis of Table 3 highlights statistically and clinically significant differences between the KMC and control groups across all domains measured by the WHO-KMC Assessment Tool. While baseline scores were comparable (p > 0.05), the KMC group demonstrated substantial improvements at each subsequent time point. Notably, pre-discharge KMC Practice Scores showed a mean difference of 5.2 points (95% CI 4.8–5.6, p < 0.001), with a large effect size (Cohen’s d = 3.57). Similar patterns were observed for Maternal Competency (final mean difference: 3.2, 95% CI 2.9–3.5, d = 2.59) and Implementation Checklist metrics (final mean difference: 5.0, 95% CI 4.5–5.5, d = 2.54). The robust time × group interaction effect (F = 89.43, p < 0.001, partial η² = 0.28) underscores that the KMC intervention not only resulted in superior outcomes but also accelerated the rate of improvement relative to standard care. Narrow confidence intervals, large effect sizes, and minimal missing data (<1.7%) reinforce the reliability and validity of these findings. These results suggest a cumulative benefit of the KMC protocol, with marked gains in practical implementation skills by pre-discharge. Future studies should explore the sustainability of these effects post-discharge and their broader applicability across diverse clinical settings.

Table 3 WHO-KMC assessment tool scores: protocol adherence and maternal competency over time

Analysis of Table 4, examining anthropometric outcomes according to WHO Preterm Growth Standards, demonstrated statistically and clinically significant differences in growth trajectories between the intervention and control groups. While baseline anthropometric measurements were comparable (p > 0.05), the KMC group exhibited progressively superior growth patterns across all parameters. The most striking difference was observed in pre-discharge weight, where the KMC group demonstrated a mean advantage of 109.5 g (95% CI 79.6–139.4, p < 0.001) with a large effect size (Cohen’s d = 0.96). Growth velocity analysis revealed consistently higher rates in the KMC group, reaching a peak difference of 2.9 g/kg/day (95% CI 2.2–3.6, p < 0.001, d = 1.00) during week 3. Linear growth and head circumference measurements similarly favored the KMC group, with final differences of 0.9 cm (95% CI 0.4–1.4, p < 0.001) and 0.7 cm (95% CI 0.4–1.0, p < 0.001), respectively. The robust time × group interaction effect (F = 76.84, p < 0.001, partial η² = 0.24) underscores the sustained and accelerating impact of KMC over time, promoting rapid and comprehensive growth compared to standard care. The consistency of these findings across all anthropometric parameters, coupled with minimal missing data (≤1.7%) and narrow confidence intervals, provides strong evidence for the effectiveness of KMC in promoting optimal growth in preterm infants. These results highlight the value of KMC as a cost-effective, family-centered intervention with the potential for widespread applicability, particularly in resource-constrained settings.

Table 4 Anthropometric measurements and growth trajectories according to WHO preterm growth standards

The findings from Table 5 underscore the transformative potential of Kangaroo Mother Care (KMC) in fostering maternal-infant bonding. By evaluating scores on the Mother-Infant Bonding Tool (MIBT) across multiple psychosocial dimensions, the study reveals that KMC consistently outperforms standard care. Baseline comparisons confirm that both groups began with statistically comparable scores across all domains (p > 0.05), ensuring the validity of subsequent intervention effects. However, the KMC group demonstrated accelerated and significantly greater improvements over time. Notably, Technical Competency exhibited the largest gains, with a pre-discharge mean difference of 1.7 points (95% CI 1.5–1.9, p < 0.001) and an exceptional effect size (Cohen’s d = 3.12). Similar trends were observed in Confidence in Caregiving (mean difference: 1.5 points, d = 3.33), Emotional Bonding (mean difference: 1.3 points, d = 2.37), and Maternal Responsiveness (mean difference: 1.4 points, d = 2.17), each with substantial clinical significance.

Table 5 Mother-infant bonding tool scores and psychosocial outcomes across study period

The robust time × group interaction effect (F = 94.68, p < 0.001, partial η² = 0.28) highlights the KMC intervention’s capacity to enhance bonding outcomes more rapidly than standard care. Importantly, the narrow confidence intervals and minimal missing data (≤1.7%) lend additional credibility to the results. These findings advocate for the integration of KMC into neonatal care as a powerful tool for advancing both maternal competencies and emotional connections in caregiving.

Table 6 demonstrates significant protective effects of KMC against neonatal morbidity and nosocomial infections. The intervention reduced late-onset sepsis (RR = 0.40, 95% CI 0.19–0.85, p = 0.014) and necrotizing enterocolitis (RR = 0.40, 95% CI 0.21–0.78, p = 0.006), with overall infection rates dropping from 33.3% in standard care to 15.0% in the KMC group (RR = 0.45, 95% CI 0.27–0.75, p < 0.001). The number needed to treat of 6.3 (95% CI 4.2–12.1) for preventing any infection indicates substantial clinical effectiveness. Secondary outcomes showed reduced antibiotic exposure (mean difference: − 3.2 days, 95% CI − 3.9 to − 2.5, p < 0.001) and shorter hospital stays (mean difference: − 6.5 days, 95% CI − 7.9 to − 5.1, p < 0.001) in the KMC group. Multivariate analysis confirmed KMC’s independent protective effect, with its absence associated with increased odds of adverse outcomes (adjusted OR = 2.70, 95% CI 1.85–3.95, p < 0.001), after adjusting for key clinical variables. The consistency of effects across outcomes, supported by narrow confidence intervals and minimal missing data, establishes KMC’s efficacy in reducing neonatal morbidity.

Table 6 Neonatal morbidity, nosocomial infection outcomes, and hospital course based on NMAT assessment

Table 7 reveals substantial advantages of KMC across respiratory support parameters, breastfeeding outcomes, and hospital course metrics. KMC recipients required significantly shorter CPAP duration (mean difference: − 2.2 days, 95% CI − 2.6 to − 1.8, p < 0.001) and lower maximum FiO₂ (mean difference: − 6.2%, 95% CI − 7.7 to − 4.7, p < 0.001). Breastfeeding success was markedly higher in the KMC group, with improved rates of early initiation (81.7% vs 60.0%, RR = 1.36, 95% CI 1.15–1.61) and exclusive breastfeeding at discharge (74.2% vs 48.3%, RR = 1.53, 95% CI 1.24–1.89). The intervention group achieved key clinical milestones earlier, including full oral feeding (mean difference: − 4.5 days, 95% CI − 5.4 to − 3.6, p < 0.001) and temperature stability (mean difference: − 2.6 days, 95% CI − 3.0 to − 2.2, p < 0.001). Hospital stays were shortened by 6.2 days (95% CI − 7.6 to − 4.8, p < 0.001) in the KMC group, with higher rates of early discharge (60.0% vs 37.5%, RR = 1.60, 95% CI 1.22–2.10) and no significant difference in readmission rates (p = 0.064). The consistently large effect sizes and narrow confidence intervals across outcomes provide robust evidence for KMC’s effectiveness in improving key neonatal care metrics.

Table 7 Comparison of respiratory support parameters, breastfeeding outcomes, and length of stay

Table 8 underscores the robust independent effects of KMC on critical clinical outcomes, as demonstrated through multivariable regression analyses. The Cox proportional hazards model revealed that KMC significantly reduced the mortality risk (adjusted HR = 0.42, 95% CI 0.28–0.63, p < 0.001), even after adjusting for gestational age, birth weight, and initial SAS scores. In the logistic regression models, KMC was a strong predictor of 28-day survival (adjusted OR = 2.84, 95% CI 1.96–4.12, p < 0.001), with excellent model discrimination (AUC = 0.86, 95% CI 0.82–0.90). Adherence to KMC for more than 6 h per day significantly enhanced infection-free survival (adjusted OR = 2.46, 95% CI 1.82–3.32, p < 0.001), while adherence rates exceeding 80% strongly predicted early discharge success (adjusted OR = 2.32, 95% CI 1.74–3.09, p < 0.001). The linear regression analysis demonstrated that KMC implementation independently shortened hospital stay by 5.84 days (95% CI − 7.12 to − 4.56, p < 0.001). The overall model explained 64% of the variance in hospital stay duration (R² = 0.64), reflecting the substantial impact of KMC on resource utilization. The consistent protective effects of KMC across statistical models, along with robust diagnostics (e.g., VIF < 3, non-significant Hosmer-Lemeshow tests, and appropriate residual plots), and narrow confidence intervals, provide compelling evidence for its efficacy. These findings underscore the importance of integrating KMC into standard neonatal care protocols to improve survival, reduce infections, promote early discharge, and optimize resource utilization.

Table 8 Multivariable regression analyses of survival and major clinical outcomes

Discussion

The present randomized controlled trial aimed to investigate the effectiveness of Kangaroo Mother Care (KMC) relative to standard neonatal care in improving survival rates and clinical outcomes for preterm infants (<2000 g) diagnosed with respiratory distress syndrome (RDS) in Tanta, Egypt. The results indicate that KMC, implemented alongside minimal or moderate respiratory support, confers significant benefits across multiple domains: reduced respiratory distress, lower nosocomial infection rates, improved growth trajectories, enhanced mother-infant bonding, and higher rates of breastfeeding initiation and continuation. In light of these findings, this discussion situates the current results within the broader neonatal care literature, highlights areas of consensus and debate, and proposes directions for clinical implementation and future research.

Respiratory outcomes and survival

One of the most salient findings was the improved respiratory status among infants in the KMC group, as evidenced by reductions in Silverman-Anderson Scores (SAS) and shorter durations of CPAP use. This aligns with prior research suggesting that skin-to-skin contact improves respiratory stability through thermoregulation, reduced stress responses, and better cardiorespiratory synchrony [81]. Additionally, consistent with earlier work by Tas Arslan et al. (2024), the present study indicates that KMC can safely be applied to infants with moderate respiratory compromise without increasing the risk of treatment failure [82]. In contrast, smaller-scale studies have expressed concern that continuous mother-infant contact may interfere with respiratory equipment and predispose infants to hypothermia [83, 84]. However, our findings of enhanced thermal stability and no observed interference with CPAP suggest that appropriate staff training and safety monitoring can mitigate such risks [85, 86]. The superior 28-day survival in the KMC group further underscores the physiological advantages afforded by sustained skin-to-skin contact and family-centered care [87].

Nosocomial infections and antibiotic use

A second pivotal outcome is the substantial reduction in nosocomial infections, including late-onset sepsis, pneumonia, and necrotizing enterocolitis (NEC) in the KMC group. These lower infection rates are consistent with earlier multi-country evaluations of KMC, where improvements in infection-free survival were attributed to continuous maternal contact, enhanced breastfeeding, and diminished exposure to the hospital environment [25]. Interestingly, the present study extends these findings to a population receiving higher levels of respiratory support, an area less thoroughly explored in prior trials. Although some critics argue that the benefits of KMC might be counterbalanced by overcrowded hospital conditions and insufficient nurse-to-patient ratios [88], the multi-center nature of the current trial, including NICUs varying in capacity and resource availability, demonstrates consistent infection-prevention benefits across diverse clinical settings [89]. Moreover, the significantly reduced antibiotic use in the KMC group indicates an additional cost-saving and antimicrobial stewardship advantage, supporting the broader assertion that KMC may serve as an effective adjunct in neonatal infection control protocols [90].

Growth trajectories and nutritional advantages

Improvements in anthropometric indices, particularly weight gain, further bolster the case for KMC’s clinical efficacy. Infants allocated to KMC achieved notably higher daily weight gains and overall growth velocity. These findings mirror prior studies linking skin-to-skin care with better feeding coordination, earlier transition to full oral feeds, and greater breastfeeding success [91, 92]. The facilitation of exclusive breastfeeding appears to be a key mechanism driving weight gain and reduced metabolic stress, as supported by the theory that consistent maternal contact boosts lactation and fosters early latch-on [93]. Nonetheless, some studies in high-income settings report that the effect of KMC on weight gain may plateau if hospital protocols limit the frequency or duration of skin-to-skin sessions [94]. Our more pronounced effects could be partially explained by protocols encouraging prolonged skin-to-skin contact daily, although differential cultural and hospital practices warrant further comparative inquiry. The robust growth outcomes collectively endorse KMC as an integrative strategy to address high-risk neonates’ nutritional and developmental needs.

Maternal-infant bonding and psychosocial dimensions

Beyond physiological advantages, this trial documents noteworthy psychosocial benefits, evidenced by higher scores on the mother-infant Bonding Tool (MIBT) and the WHO-KMC Assessment Tool in the KMC group. These improvements are consistent with Jespersen et al (2021), who highlighted that providing education and hands-on support to caregivers fosters maternal confidence, reduces anxiety, and enhances responsive parenting behaviors [95]. Notably, maternal competency in carrying out KMC increased substantially over the study period, reflecting the importance of structured training led by neonatal nurses. Critics of KMC’s psychosocial impact often focus on cultural barriers, positing that beliefs regarding neonatal fragility may discourage parents from sustained skin-to-skin contact [12]. Yet the present trial found high KMC adherence across socioeconomically and culturally diverse mothers, suggesting that provider-led education can effectively mitigate concerns and foster more accepting attitudes toward skin-to-skin care.

Contradictory evidence and points of debate

Although our results strongly support KMC for preterm infants with RDS, it is prudent to acknowledge research that raises concerns regarding the feasibility of neonates requiring mechanical ventilation or high-frequency respiratory support. Some authors caution that position changes during prolonged skin-to-skin care could disrupt ventilator settings or inadvertently extubate infants with fragile endotracheal tubes [96]. Our study, which primarily included infants on CPAP, did not explore mechanical ventilation scenarios. Hence, while the data challenges the assumption that KMC is safe only for stable infants, questions remain regarding its applicability to the most critically ill neonates. Moreover, while the consensus largely favors KMC’s immunological and developmental benefits, certain stakeholders worry about the additional nursing workload that might burden already overtaxed NICU personnel [97]. Future implementation research could explore staffing models, training strategies, and logistical considerations to integrate KMC effectively in high-acuity settings [61].

Limitations

Several limitations require careful interpretation of the study’s outcomes. First, because complete blinding was not feasible for caregivers, some degree of performance bias may be present given the visible nature of skin-to-skin contact. Second, although we were randomized and stratified by gestational age and birth weight, other potential confounders such as maternal nutritional status, breastfeeding support at home, or cultural norms were not exhaustively measured. Third, the study population was drawn from a single geographic region (Tanta, Egypt), which may limit the broader applicability of these findings to other cultural or healthcare contexts. Additionally, we focused on preterm infants who met minimal respiratory stability criteria. The exclusion of more severely compromised neonates may curb the study’s generalizability to the sickest subsets of RDS. Finally, while post-discharge follow-up extended 28 days, our data does not capture the intervention’s longer-term neurodevelopmental and psychosocial sequelae, pointing to the need for extended follow-up.

Practical Implications and Future Directions

From a clinical standpoint, integrating KMC as a standard intervention for preterm infants with RDS could substantially reduce hospital-acquired infections, shorten hospitalization times, and improve breastfeeding success, all of which alleviate economic burdens on healthcare systems. Given these findings, policymakers and hospital administrators in low- and middle-income countries (LMICs) may consider formally incorporating KMC into existing neonatal care guidelines. Moreover, training programs for nurses and maternal caregivers should emphasize both the technical and psychosocial dimensions of KMC, ensuring the confident and safe application of skin-to-skin care alongside respiratory support.

Directions for future research include evaluating KMC in neonates requiring mechanical ventilation or advanced respiratory therapies, thereby clarifying its applicability across broader severity levels of RDS. Longitudinal studies beyond the neonatal period could illuminate whether early KMC confers sustained benefits in neurodevelopmental outcomes, cognitive performance, and parent-child attachment. Meanwhile, cost-effectiveness analyses would further substantiate the financial and operational advantages of KMC in resource-limited settings, guiding the strategic allocation of healthcare funds. Qualitative research might also examine parental and staff perceptions of KMC to refine educational strategies and identify social or cultural barriers that could hinder adoption in certain contexts.

Conclusion

This randomized controlled trial underscores the transformative potential of KMC in enhancing neonatal outcomes for preterm infants with respiratory distress syndrome in a resource-limited context. By integrating family-centered principles with structured clinical protocols, the KMC framework emerged as both feasible and impactful, addressing a broad range of neonatal challenges from respiratory support to maternal-infant bonding. Nursing expertise proved vital to the success of the intervention, reinforcing the importance of professional capacity-building and interprofessional collaboration in neonatal care. Beyond its immediate clinical benefits, KMC aligns with global imperatives to reduce neonatal mortality through cost-effective, evidence-based strategies. Its emphasis on continuous skin-to-skin contact and exclusive breastfeeding provides a pragmatic model for bridging systemic gaps in healthcare infrastructure, particularly in low- and middle-income countries. The favorable psychosocial effects on mothers and families further illustrate the holistic value of KMC, suggesting that the synergistic benefits of enhanced caregiver education, thermoregulation, and breastfeeding advocacy can be replicated across diverse healthcare settings. These findings encourage the integration of KMC into broader neonatal policies and highlight opportunities for future inquiry. Research exploring KMC’s long-term impact on neurodevelopment, its applicability to more critically ill infants, and its cost-effectiveness in varied clinical environments would bolster the growing body of evidence supporting its widespread adoption. By centering on both the physiological and psychosocial dimensions of newborn care, KMC offers a blueprint for innovation in neonatal practice and a compelling avenue for reducing health disparities among high-risk preterm populations.