Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants

Completed

• Conditions: Preterm Infants

• Registration Number: NCT03841994
• Lead Sponsor: Seoul National University Hospital

Brief Summary

A prospective cohort study investigating the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

Detailed Description

The purpose of this study was to investigate the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

Study Timeline

• Study Start: 2018-12-04
• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Primary Completion: 2024-04-28
• Study Completion: 2024-04-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Preterm infants
• born less than 28+0 weeks gestation

Exclusion Criteria

• Major congenital anomalies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment	at 37~40 weeks of postmenstrual age	Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice

Secondary Outcome Measures

Name	Time	Method
Bayley scales of infant and toddler development, third edition	at 18~24 months of corrected age	For neurodevelopmental screening, Bayley scales of infant and toddler development, third edition yields composite scores for each cognitive, language, motor.; It is considered normal when \>85. Developmental delay is diagnosed when the mean result is below 85.; Neurodevelopmental screening is considered normal when a child achieves these all.
Incidence of major morbidity	at 36~40 weeks of postmenstrual age	Major morbidity such as bronchopulmonary dysplasia, periventricular leukomalacia, retinopathy of prematurity
Brain MRI	at 37~40 weeks of postmenstrual age	white matter injury
Comparison of inflammation markers	with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age	Comparison of inflammation markers such as Interleukin(IL)-1 beta/IL-1F2, IL-6, IL-8/CXCL8, Tumor necrosis factor(TNF)-alpha, etc.
Comparison of short chain fatty acid at 4 period	with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age	Comparison of short chain fatty acid in stool and blood at 4 period

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of