Effect of Kangaroo Mother Care during the first 72 hours of life on early growth and breastfeeding in normal birth weight newborns: Protocol for a Randomised Controlled Trial

ABSTRACT Introduction Skin-to-skin contact during the first hour of birth is recommended for healthy newborn infants and their mothers and improves early stabilisation and breastfeeding outcomes. Kangaroo Mother Care (KMC), involving prolonged skin-to-skin contact (SSC) and exclusive breastfeeding, provides an optimal physiological transition from intrauterine to extrauterine life for preterm and low birth weight infants, improving survival by 32% and conferring multiple clinical and neurodevelopmental benefits. Extending the duration of SSC contact beyond the first hour may similarly confer underexplored benefits to normal birth weight infants, including improved stabilisation, breastfeeding, growth, and maternal-infant bonding. The study aims to evaluate the effect of KMC during the first 72 hours on early weight loss, weight gain velocity and breastfeeding quality in normal birthweight infants. Methods and Analysis This multicentre, individually randomised, controlled, open-label superiority trial will enrol 516 healthy singleton neonates with birth weight ≥2500 grams and their mothers with uncomplicated vaginal deliveries from 3 public health facilities in Uttar Pradesh, India. Dyads will be randomised (1:1) and stratified by site to either intervention or control groups. The intervention involves prolonged KMC (≥8 hours of daily SSC with exclusive breastfeeding in the KMC position) during the initial 3 days after birth, with a recommendation to continue KMC at home throughout the newborn period. Both intervention and control groups will receive a common minimum care package, including breastfeeding initiation through uninterrupted SSC in the first hour, essential newborn care counselling, vaccinations and other standard facility care. The primary outcomes are: 1) mean percentage weight loss at 48 hours; 2) weight gain velocity up to 28 days; and 3) the proportion of dyads with moderate-to-poor quality breastfeeding scores (BBAT <7) at age 7 completed days. Secondary outcomes include exclusive breastfeeding rates, maternal breastfeeding experience, incidence of possible serious bacterial infection, maternal depression, and maternal-infant bonding. Data will be collected electronically using standardised tools with quality control measures. Primary outcomes will be analysed using Linear Mixed-Effects Models (continuous) and Mixed-Effects Logistic Regression (binary) on an Intention-to-Treat basis, adjusting for study site, parity, infant sex, and baseline birth weight. A p-value <0.05 will be considered statistically significant. Ethics and Dissemination The study is approved by the institutional ethics committees of the Community Empowerment Lab and King George’s Medical University. Written informed consent will be obtained from participating mothers. All findings will be disseminated regardless of the outcome, through publication in peer-reviewed journals, presentations at international conferences, and policy briefings to local health authorities. Data will be deposited in an open-access repository to promote data sharing and transparency. The results are intended to inform national and international guidelines on essential newborn care for the global population of healthy, term infants. Strengths and limitations of the study This study fills an important evidence gap, being the first multi-centre randomised controlled trial to evaluate prolonged KMC benefits for normal birthweight infants, a group that has largely been excluded from prior KMC research. The study will conduct a rigorous and objective assessment of a range of important newborn and maternal outcomes, including physical growth, quality of breastfeeding and exclusive breastfeeding, maternal mental health and mother-infant bonding, providing a holistic understanding of KMC’s effects on the newborn-mother dyad. The visible nature of KMC makes blinding participants and implementers impossible, however, extensive measures have been undertaken to minimise bias. Being the first study of its kind, it excludes Caesarean section and complicated births to simplify the intervention, analysis and subsequent interpretation. Administrative information Title Effect of Kangaroo Mother Care during the first 72 hours of life on early growth and breastfeeding in normal birth weight newborns: Protocol for a Randomised Controlled Trial Trial registration This trial has been registered with the Clinical Trials Registry of India CTRI/2024/01/062057 (date: 30/01/2024) and International Standard Randomised Controlled Trial Number ISRCTN14346778 (date: 19/12/2024). Protocol date and version September 10, 2024; CEL/KMC_NormalBW/V3.1. The full study protocol and statistical analysis plan will be available as supplementary material accompanying the published manuscript. The protocol has also been uploaded to the CTRI registry. Funding & Role of sponsor This work was supported by Indian Council of Medical Research (Project number: IIRP-2023-7329). The sponsor has no role in the design, conduct, analysis and reporting of the trial, but provides study oversight through a scientific review committee. Sponsor contact information Indian Council of Medical Research (ICMR), New Delhi – 110029, India Email: icmrhqds@sansad.nic.in