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

May 23, 2022 updated by: Ee-Kyung Kim, Seoul National University Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ee-Kyung Kim, M.D., PhD.
  • Phone Number: +82220723628
  • Email: kimek@snu.ac.kr

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preterm infants who are born at < 28 weeks of gestation and admitted to the neonatal intensive care unit at Seoul national university children's hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Major congenital anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Preterm infant cohort
Preterm infants who were born <28 weeks of gestational age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 24 hours after birth
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
2 weeks after birth
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
3~5 weeks after birth
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
at 37~40 weeks of postmenstrual age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain MRI
Time Frame: at 37~40 weeks of postmenstrual age
white matter injury
at 37~40 weeks of postmenstrual age
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.
at 18~24 months of corrected age
Incidence of major morbidity
Time Frame: at 36~40 weeks of postmenstrual age
Major morbidity such as bronchopulmonary dysplasia, periventricular leukomalacia, retinopathy of prematurity
at 36~40 weeks of postmenstrual age
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.
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
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
with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ee-Kyung Kim, M.D., PhD., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2018

Primary Completion (Anticipated)

February 28, 2023

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

February 1, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1801-128-917

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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