A Prospective-Retrospective Observational Cohort Study of Short-Term Health Outcomes of Preterm Very Low Birth Weight Infants Receiving Oropharyngeal Administration of Own Mother's Colostrum

Curr Ther Res Clin Exp. 2026 Feb 7:104:100824. doi: 10.1016/j.curtheres.2026.100824. eCollection 2026 Jun.

Abstract

Introduction: Mother's milk has been associated with better health outcomes in preterm infants, including reduced sepsis and necrotizing enterocolitis (NEC) severity, as well as improved neurodevelopment. This study aims to compare the short-term health outcomes of preterm very low birth weight (VLBW) infants who receive oropharyngeal Own Mother's Colostrum (OMC) with those who do not.

Methods: A single-centre observational cohort study with prospective OMC cohort and retrospective control cohort was conducted in a Level III neonatal intensive care unit (NICU) in Western Maharashtra (April 2021 to June 2022). Group 1 (prospective cohort) received OMC every 3 hourly for 48 h. Data for Group 2 (retrospective cohort) were collected from NICU records (January to December 2019) when OMC was not administered. Statistical analysis was performed using IBM SPSS Statistics Version 20, with multivariable logistic regression adjusting for potential confounders.

Results: In 302 participants (n = 151 each), mean gestational age (GA) 32.1 weeks and birth weight 1324.2 g, OMC administration was associated with lower NEC incidence (4.6% vs 11.9%, P < 0.007) and lower early-onset sepsis (EOS), including proven and clinical sepsis (9.9% vs 18.5%, P < 0.05). Secondary outcomes showed accelerated time to full enteral feeding and improved weight gain in the OMC cohort. Mortality was numerically lower in the OMC group (1.3% vs 7.9%); however, this was a secondary outcome with findings considered hypothesis-generating pending randomized controlled trial (RCT) validation. Logistic regression analysis adjusting for lower segment caesarean section, respiratory distress syndrome, and GA showed that OMC remained independently associated with lower NEC incidence (OR 0.35, 95% confidence intervals: 0.14-0.89, P = 0.028). Feasibility assessment demonstrated high maternal acceptance, procedural adherence, and no adverse events attributable to OMC.

Limitations: As a single-centre observational study with prospective and retrospective cohorts, findings are subject to temporal bias, survivor bias for secondary outcomes, co-intervention bias, and limited generalizability to other settings, particularly high-income NICUs with different resource profiles and staffing patterns.

Conclusions: Early oropharyngeal administration of OMC was independently associated with reduced NEC and EOS in preterm VLBW infants after adjustment for measured confounders, with favorable secondary outcomes in feeding tolerance and growth. Mortality findings require cautious interpretation as a secondary, hypothesis-generating outcome. Feasibility and safety profile support prioritization for evaluation in adequately powered, multicenter RCTs before considering clinical implementation.

Keywords: NEC; VLBW; oropharyngeal administration; own mother’s colostrum; preterm; sepsis.