Oral Application of Colostrum and Mother's Own Milk in Preterm Infants-A Randomized, Controlled Trial

Indian J Pediatr. 2022 Jan 10. doi: 10.1007/s12098-021-03982-4. Online ahead of print.


Objectives: To evaluate the effects of oral application of mother's own milk (OMOM) on clinical outcomes in preterm infants of 260/7-306/7 wk gestation.

Methods: In this placebo-controlled randomized trial, subjects received either OMOM or sterile water, beginning at 24-72 h of life, until the infant reached 32 wk postmenstrual age or spoon-feeds were initiated, whichever was earlier. The primary outcome was a composite adverse health outcome, defined as the occurrence of either mortality, late-onset sepsis (LOS), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), or retinopathy of prematurity (ROP). Antibiotic usage and time to full enteral feed were secondary outcomes. Salivary IgA (sIgA) levels at baseline and after 7 d of application in a subset of infants were also compared.

Results: A total of 133 neonates (66 colostrum and 67 placebo) were analyzed for the primary outcome. OMOM group had lower incidence of composite adverse health outcome (43.9% vs. 61.2%, RR: 0.70; 95% CI: 0.50-0.99, p = 0.046) and LOS (22.7% vs. 43.3%, RR: 0.73; 95% CI: 0.57-0.93; p = 0.012). There were no significant differences in mortality, NEC, IVH, BPD, ROP, and time to full feeds. The effects were more pronounced in the 290/7-306/7 wk subgroup, in whom the colostrum group also achieved full feeds earlier. There were no differences in the change of sIgA levels from baseline to the seventh day of the application. No adverse effects related to the OMOM application were found.

Conclusions: OMOM decreases the incidence of late-onset sepsis in preterm neonates (260/7-306/7 wk) and is safe.

Trial registration: Clinical Trials Registry-India CTRI/2017/03/008031.

Keywords: Adverse health outcome; Colostrum; Immunotherapy; Necrotizing enterocolitis; Preterm; Salivary immunoglobulin A; Sepsis.