This randomized controlled trial evaluates whether Kangaroo Mother Care (KMC) during CPAP improves lung aeration in preterm neonates, measured by serial lung ultrasound (LUS) scores. The study addresses a significant clinical gap: while KMC is an established low-cost intervention with proven physiological benefits, limited randomized evidence exists comparing LUS-guided outcomes in preterm infants on CPAP with versus without concurrent KMC.

Clinical Rationale

Preterm infants with respiratory distress syndrome require continuous positive airway pressure (CPAP) as the standard non-invasive respiratory support. However, prolonged CPAP carries risks including nasal trauma and feeding delays. KMC, defined as sustained skin-to-skin contact of at least 1 hour per session for a minimum of 4 to 6 hours daily, has demonstrated benefits in reducing apnea, bradycardia, and oxygen desaturation while promoting cardiorespiratory stability. LUS offers a radiation-free, reproducible bedside method for assessing lung aeration and monitoring treatment response. The protocol leverages LUS to objectively quantify whether KMC enhances lung recovery during CPAP support.

Methodology

Study Design: Open-label, two-arm, parallel-group randomized controlled trial with 1:1 allocation conducted over 12 to 18 months at a single NICU center in Gujarat.

Population and Enrollment: The study includes preterm neonates aged 28 to 36 weeks gestation requiring CPAP initiated within 24 hours of life, with birth weights between 900 grams and 2.0 kilograms. Inclusion requires clinical stability (oxygen fraction inspired less than or equal to 0.40, CPAP pressures less than or equal to 7 centimeters H2O, hemodynamic stability) and parental consent. Exclusion criteria include major congenital anomalies, need for immediate intubation, severe cardiorespiratory instability, and maternal contraindications to KMC.

Randomization and Intervention: Computer-generated randomization with sealed opaque envelope allocation assigns participants to either KMC (at least 4 hours daily in at least 1 hour sessions during CPAP) or standard NICU care without KMC. The intervention remains feasible within resource-limited settings, requiring no additional equipment.

Data Collection: Serial LUS assessments occur at baseline (within 6 hours of CPAP initiation), 4, 8, 12, 24, and 48 hours. Concurrent measurements include oxygen requirement (oxygen fraction inspired), vital signs (heart rate, temperature, oxygen saturation), and clinical parameters (episodes of apnea, bradycardia, desaturation). Baseline data capture maternal demographics, antenatal history, neonatal anthropometry, Apgar scores, and clinical diagnosis. Maternal feasibility is evaluated via structured questionnaire.

Primary Outcome: Change in LUS score from baseline to 48 hours between groups.

Secondary Outcomes: LUS scores at intermediate timepoints, CPAP duration, need for intubation or surfactant within 7 days, bronchopulmonary dysplasia at 36 weeks corrected age, NICU stay duration, mortality, incidence of hypothermia and cardiorespiratory events during the first 72 hours, and adverse events (accidental CPAP dislodgement, sepsis, maternal complications).

Statistical Analysis: With an assumed moderate effect size of 50 points difference in LUS score, the study requires 63 participants to achieve 80 percent power at 5 percent type I error. The sample size is increased to 75 participants accounting for 20 percent attrition from death or escalation to mechanical ventilation. Baseline characteristics are summarized descriptively using mean, standard deviation, and frequency percentages. The primary outcome improvement is assessed using paired t-tests and repeated measures designs, with between-group contrasts analyzed using repeated measures analysis of variance or analysis of covariance. Statistical significance is set at p-value less than 0.05 using STATA 19 software.

Ethical Protections

Written informed consent is required from parents. Participant confidentiality is maintained, and treating clinicians retain autonomy in managing complications such as feed intolerance. Publication is planned in indexed journals per institutional guidelines. The protocol requires no external funding.

This methodology addresses a clinically relevant question with appropriate measurement tools (LUS), rigorous randomization, and comprehensive outcome assessment while remaining implementable in resource-constrained neonatal settings.