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Impact of colostrum oropharyngeal immunotherapy on postnatal growth in preterm infants based on early gut
Na Wang1, Yan Hu2, Weibing Qiu3
1Department of Neonatology, The Affiliated Suqian First People's Hospital of Nanjing Medical University, 120 Suzhi Road, Suqian, Jiangsu, China.
Insights
Oropharyngeal colostrum administration may reduce extrauterine growth restriction (EUGR) in very preterm infants. This trial will assess its impact on growth and gut microbiota, providing evidence for clinical use.
Area of Science:
- Neonatal Medicine
- Microbiology
- Pediatric Nutrition
Background:
- Extrauterine growth restriction (EUGR) affects many very preterm infants (<32 weeks' gestation), often linked to delayed feeding.
- Oropharyngeal colostrum administration is an alternative to early enteral feeding, but its effectiveness in preventing EUGR is uncertain.
Purpose of the Study:
- To investigate the impact of oropharyngeal colostrum administration on extrauterine growth restriction (EUGR) in very preterm infants.
- To evaluate the effect on time to regain birth weight and gut microbiota composition.
- To establish a scientific basis for clinical application of this intervention.
Main Methods:
- A multicenter randomized controlled trial involving 260 very preterm infants.
- Infants randomly assigned to oropharyngeal colostrum or placebo (normal saline) for 5 days within 48-72 hours of birth.
- Primary outcome: EUGR at discharge. Secondary outcomes: time to regain birth weight, gut microbiota differences.
Main Results:
- This section is to be filled once the study is completed and results are available.
Conclusions:
- This study will provide crucial data on the efficacy of oropharyngeal colostrum in preventing EUGR.
- Findings will offer new insights into gut microbiota interactions and inform clinical strategies for preterm infant growth.
Background:
Extrauterine growth restriction (EUGR), prevalent and severe in very preterm infants (< 32 weeks' gestation), means discharge growth values (weight, head circumference, or length) are ≤ 10th percentile on the Fenton 2013 chart. Many of these infants fast or have delayed oral feeding soon after birth. Oropharyngeal colostrum administration, using a syringe or sterile swab, is an alternative to early enteral colostrum feeding. As the effectiveness of oropharyngeal colostrum administration in reducing the incidence of EUGR in preterm infants remains unclear, a randomized trial design is crucial for addressing this question. This proposed study protocol investigates the impact of oropharyngeal colostrum administration on the time to regain birth weight and postnatal growth in very preterm infants, based on the interaction between early gut microbiota and the host.
Methods:
We plan to perform this multicenter randomized controlled trial by recruiting 260 very preterm infants from September 2025 to August 2028. The study will be conducted at five neonatal intensive care units (NICUs) in Jiangsu Province, China. The study population will be randomly assigned to either the oropharyngeal colostrum administration group or the placebo (normal saline) group. The intervention will commence within 48-72 h of birth and and will be administered continuously for a duration of 5 days, with stool samples collected from the preterm infants before and after the intervention. The primary outcome measure is the incidence of EUGR at discharge, while the secondary outcome measures include differences in the time to regain birth weight and gut microbiota between groups. This study will use a multivariate logistic regression to evaluate the association between oropharyngeal colostrum administration and EUGR, multiple tests (T-test, Wilcoxon, repeated measures analysis of variance) for gut microbial diversity differences, and a generalized linear model for the association between the intervention and gut microbiota composition.
Discussion:
This study aims to provide a scientific basis for the clinical application of oropharyngeal colostrum administration in preterm infants through rigorous clinical trials and intestinal flora analyses and to provide new insights into intervention strategies for EUGR in preterm infants.
Trial Registration:
ClinicalTrials.gov identifier: NCT07082881. Registered 16 July 2025.
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