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

Seoul National University Hospital1 site in 1 country47 target enrollmentDecember 4, 2018

ConditionsPreterm Infants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Preterm Infants
Sponsor: Seoul National University Hospital
Enrollment: 47
Locations: 1
Primary Endpoint: The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 4, 2018

End Date

April 28, 2024

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Ee-Kyung Kim

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Major congenital anomalies

Outcomes

Primary Outcomes

The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment

Time Frame: at 37~40 weeks of postmenstrual age

Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice

Secondary Outcomes

Bayley scales of infant and toddler development, third edition(at 18~24 months of corrected age)
Incidence of major morbidity(at 36~40 weeks of postmenstrual age)
Brain MRI(at 37~40 weeks of postmenstrual age)
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 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)