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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03841994

Enrollment

Registered

2019-02-15

Start date

2018-12-04

Completion date

2024-04-28

Last updated

2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants

Keywords

microbiome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Weeks

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Major congenital anomalies

Design outcomes

Primary

Measure	Time frame	Description
The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment	within 24 hours after birth	Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice

Secondary

Measure	Time frame	Description
Brain MRI	at 37~40 weeks of postmenstrual age	white matter injury
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
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

Countries

South Korea

Outcome results