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Completed

NCT Number: NCT03841994

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

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.

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Key information

Conditions

Preterm Infants

Age range

Up to 28 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Major congenital anomalies

Treatment and study plan

Primary outcomes

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

    Time frame: within 24 hours after birth

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

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

    Time frame: 2 weeks after birth

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

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

    Time frame: 3~5 weeks after birth

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

  4. 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

  1. Brain MRI

    Time frame: at 37~40 weeks of postmenstrual age

    white matter injury

  2. Bayley scales of infant and toddler development, third edition

    Time frame: 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.

  3. Incidence of major morbidity

    Time frame: at 36~40 weeks of postmenstrual age

    Major morbidity such as bronchopulmonary dysplasia, periventricular leukomalacia, retinopathy of prematurity

  4. Comparison of inflammation markers

    Time frame: 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.

  5. Comparison of short chain fatty acid at 4 period

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 15, 2019
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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