Impact of oropharyngeal colostrum therapy on early nutritional maturation, enteral transition, and nicu recovery outcomes in very preterm infants: a randomized controlled trial

Very preterm infants often experience delayed nutritional maturation and prolonged dependence on parenteral nutrition, increasing the risk of sepsis, necrotizing enterocolitis (NEC), and impaired early growth. Oropharyngeal administration of maternal colostrum (OAC) has been proposed as an early immunopurified strategy to support gastrointestinal adaptation. This randomized controlled trial evaluated whether a standardized 8-day OAC protocol could accelerate enteral feeding progression, enhance early growth efficiency, and improve short-term NICU recovery outcomes in very preterm infants. A total of 91 infants were randomized (45 OAC; 46 control). Infants receiving OAC initiated enteral feeding earlier (median 6 vs. 12 days) and achieved full enteral feeding sooner (median 18 vs. 25.5 days). Growth velocity was significantly higher in the OAC group (9.51 vs. 5.12 g/kg/day). OAC was associated with markedly lower rates of culture-proven sepsis (31.7% vs. 78.9%) and NEC (7.3% vs. 31.6%), although these secondary outcomes were exploratory and not adjusted for multiple comparisons. Duration of antibiotic therapy was shorter in the OAC group (median 10 vs. 18 days). No intervention-related adverse events occurred. Overall, OAC may support earlier nutritional maturation and short-term recovery in very preterm infants, warranting confirmation in larger multicenter trials. IRCT20240501061616N1. Registered prospectively on 2024-07-30