Oropharyngeal colostrum therapy and exploratory respiratory outcomes in preterm infants: a randomized controlled trial

Abstract

To evaluate exploratory respiratory outcomes associated with oropharyngeal administration of colostrum (OAC) in preterm infants born at < 33 weeks’ gestation. In this single-center randomized controlled trial, 91 infants were randomized to OAC (0.2 mL every 6 h for 8 days; n = 45) or routine care ( n = 46). Respiratory outcomes were prespecified in the ethics-approved protocol and analyzed as exploratory outcomes. OAC was associated with shorter observed durations of continuous positive airway pressure (mean difference − 2.11 days), mechanical ventilation (− 2.99 days), and total respiratory support (− 4.82 days). Death or bronchopulmonary dysplasia occurred less frequently with OAC (24.4% vs. 52.2%; RR 0.47, 95% CI 0.27–0.81; P = 0.006), and live discharge was more frequent (Gray’s test, P = 0.031). No intervention-related adverse events occurred. These exploratory findings are limited by possible truncation of duration outcomes by death, modest sample size, absence of sham stimulation, and no multiplicity adjustment. IRCT20240501061616N1 (prospectively registered; 10 May 2024).