Application of buccal mucosal colostrum for first 48 hours of life to nenonates admitted in neonatal intensive care unit to prevent late onset neonatal sepsis within 14 days of life in a tertiary care hospital: A rondomised controlled trial

This randomized controlled trial aims to evaluate the effectiveness of buccal mucosal colostrum administration in preventing late-onset neonatal sepsis (LOS) among neonates admitted to the NICU within the first 6 hours of life. It will be conducted at Maharaja Agrasen Medical College, Agroha, the study will include 200 neonates randomly assigned into two groups: an intervention group receiving colostrum applied to the buccal mucosa every 3 hours for the first 48 hours, and a control group receiving standard NICU care without colostrum application. The primary objective is to compare the incidence of LOS (sepsis occurring after 72 hours of life) within the first 14 days. Secondary outcomes include the incidence of necrotizing enterocolitis (NEC), duration of hospital stay, and mortality. The study will use double-blinding and block randomization to ensure unbiased results. Exclusion criteria include neonates with major congenital anomalies, early-onset sepsis, unavailability of maternal colostrum, HIV-positive mothers, and neonates able to be fed orally within 48 hours. Data will be statistically analyzed using OpenEpi software, with a p-value <0.05 considered significant. Ethical approval has been obtained, and written informed consent will be taken from all participants’ Parents.