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Original Article - Clinical trial

Short-term outcomes of oropharyngeal administration of colostrum in preterm neonates: a double-blind placebo-controlled randomized trial

Ameneh lamsehchi^1,3, Maryam Shokouhi Solgi^1,2, Mohammad kazem Sabzehei^1,2, Behnaz Basiri^1,2  , Elahe Talebi Ghane⁴, kiana kimiayi Asadi⁵, Sina Azadnajafabad^3,6

¹Department of Neonatology, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran, Hamadan, Iran
²Clinical Research Development Center, Fatemieh Hospital, Hamadan, Iran, Hamadan, Iran
³Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran, Tehran, Iran
⁴Modeling of Noncommunicable Diseases Research Center, Hamadan University of Medical Sciences, Hamadan, Iran, Hamadan, Iran
⁵Hamadan University of Medical Sciences, Hamadan, Iran, Hamadan, Iran
⁶Non-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran, Tehran, Iran

Correspondence Behnaz Basiri ,Email: behnazbasiri@yahoo.com

Received: April 1, 2024; Revised: June 16, 2024   Accepted: June 30, 2024.

Abstract

Background
The oropharyngeal administration of colostrum (OAC) in neonates has several benefits.
Purpose
To investigate the short-term outcomes of OAC in preterm neonates.
Methods
We performed this two-arm, double-blind, placebo-controlled randomized trial at a tertiary neonatal center in Iran in 2021–2023. The intervention and control arms received 0.2 mL of their mother’s colostrum or distilled water via oropharyngeal administration every 6 h for 3 days starting from birth until 72 h of age. The main study outcomes were neonatal death, the incidence of necrotizing enterocolitis (NEC), sepsis, retinopathy of prematurity (ROP), length of hospital stay, and period to full enteral feeding. A regression analysis was used to adjust for possible confounders.
Results
A total of 126 neonates (mean gestational age, 30.05 weeks) were randomized to the intervention and placebo groups (n=63 each) and had a mean ± SD weight of 1247 ± 193 vs 1156 ± 215 g (P=0.013) and 1- and 5-min Apgar scores of 6.35 vs 5.38 (P=0.003) and 7.84 vs 7.13 (P=0.001), respectively. The mortality rate was 12.7% in the intervention group versus 14.3% in the placebo group (P=0.794). The NEC rate was significantly lower in the intervention versus placebo arm (11.1% vs. 28.6%, respectively; P=0.010), as was the clinically suspected sepsis rate (15.9% vs. 39.7%, respectively; P=0.004). The ROP and bronchopulmonary dysplasia rates did not differ significantly between groups after the adjustment for confounders. The mean length of hospital stay was shorter in the intervention group (26.1 vs. 37.32; P=0.023). Moreover, the mean duration of antibiotic therapy and period to full feeding were significantly shorter in the intervention group.
Conclusion
OAC could effectively decrease the incidence of complications in preterm infants and facilitate earlier patient discharge.

Keywords :Colostrum, Preterm, Newborn, Randomized controlled trial, Necrotizing enterocolitis