Effect of immediate kangaroo mother care (iKMC) on neonatal mortality and culture-positive sepsis in low-birth-weight neonates in district hospitals in Chhattisgarh, India (PRISM study): protocol for a stepped-wedge cluster randomized trial.

backgroundThe high rates of culture-positive sepsis, sepsis-related mortality, and multidrug resistance in neonates admitted to special care newborn units in district hospitals (DH) in India necessitate urgent actions to prevent infections in these settings. Immediate kangaroo mother care (iKMC), initiated before stabilization within the first few hours of life, has been shown to reduce neonatal mortality among low birth weight (LBW) neonates admitted to tertiary care hospitals. However, the effect of iKMC on sepsis and sepsis-related mortality, particularly in DH, remains unclear. This study aims to evaluate whether iKMC can lower the incidence of mortality or culture-positive sepsis in LBW neonates admitted to neonatal units in district hospitals.

methodsThis stepped-wedge cluster randomized trial will be conducted in ten district hospitals in Chhattisgarh, India, over 42 months. All neonates weighing between 1000 and 1799 g at birth and admitted to the participating hospitals, in whom KMC can be initiated within 12 h of life, will be eligible for inclusion. During the pre-intervention period (control), routine KMC will be practiced at the sites as is. Following a baseline period of 6 months, iKMC will be implemented sequentially in ten steps across the ten study sites at intervals of 3 months. The intervention includes initiating continuous skin-to-skin contact with the mother or relatives within 12 h of life, continuing KMC until discharge or weight 2.5 kg, and providing breastfeeding support. The primary outcome is the incidence of all-cause neonatal mortality and/or culture-positive sepsis until 28 days of life. Relative risks with 95% confidence intervals will be reported and analyzed using a generalized linear mixed model. An intention-to-treat analysis will be conducted. DISCUSSION: The PRISM (Protective Role of Immediate KMC in neonatal Sepsis and Mortality) trial will sequentially implement iKMC for LBW neonates in ten district hospitals with a relatively high burden of sepsis in India. If proven effective in reducing the risks of sepsis or neonatal mortality, the trial will provide necessary evidence for its safety and efficacy, as well as the impetus for implementing and upscaling the intervention in district hospitals across India and other low- and middle-income countries.

trial registrationClinical Trial Registry of India, CTRI/2024/09/074269. Registered on 24/09/2024, https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTE0MzY3&Enc=&userName=immediate%20kangaroo%20mother%20care .