Short-Term Outcomes of Early Oral Colostrum Administration in VLBW Neonates: An Open-Label Randomized Controlled Trial.

Background: Oropharyngeal colostrum priming (OCP) has been proposed as a potential nutritional option for very low birth weight (VLBW) newborns. This study aimed to determine short-term outcomes of early oral colostrum administration in VLBW neonates.

Methods: This open-label randomized controlled trial was conducted on VLBW neonates admitted to Mahdieh Hospital, Tehran, Iran, between February and December 2022. According to the protocol, all eligible neonates were randomized evenly to the intervention group, which received oral colostrum (OC), and the control group, which received no OC. Finally, short-term outcomes of early OC administration were compared between groups using the independent-samples t test, chi-square, and Fisher exact tests.

Results: Of 80 randomized neonates, 37 and 39 from the intervention and control groups entered the final analysis, respectively. Neonates in the intervention and control groups did not significantly differ in terms of peripherally inserted central catheter (PICC) infection (P = 0.728), sepsis (P = 0.904), necrotizing enterocolitis (NEC) (P > 0.999), intraventricular hemorrhage (IVH) (P = 0.141), retinopathy of prematurity (ROP) (P = 0.923), and bronchopulmonary dysplasia (BPD) (P = 0.633). Furthermore, there was no significant difference between groups considering the time to reach 120 cc/kg feeds (P = 0.557), time to reach birth weight (P = 0.157), length of hospitalization (P = 0.532), and mortality rate (P = 0.628).

Conclusion: The results of our study revealed that despite safety, early OC administration did not improve any of the short-term outcomes in VLBW neonates.