Metagenomic Analysis of Gut Microbiome in Preterm (MAGMP)

July 29, 2017 updated by: Byoungkook Lee, Wonju Severance Christian Hospital

Metagenome Analysis of Intestinal Microbiome in Mortality and Morbidity of Preterm Infants

This is single center study. The investigators will try to know that relationships between intestinal microbiome and mortality in preterm infants and what relationships is between intestinal microbiome in preterm infants and morbidity, mortality.

Study Overview

Status

Unknown

Conditions

Detailed Description

Microbiome is the collection of all the microorganisms living in association with the human body which are consist of eukaryotes, archaea, bacteria and viruses. Microbiome in an average human body number are ten times more than human cells and have about 1000 more genes than are present in the human genome. There are symbiotic relationships between human and microbiome. If investigators are able to know about relationships between newborn and intestinal microbiome, mortality and morbidity in preterm infants may be improved. The investigators will collect the first and weekly stool of participants and analyze DNA of microbiome thorough Metagenomic anlysis. The results between 3 groups(preterm, late preterm and full-term infants) will be compared. The investigators expect that a mean distribution of intestinal microbiome in newborns(preterm, late preterm and full-term) is defined and that relationships between mortality, morbidity and intestinal microbiome.

Study Type

Observational

Enrollment (Anticipated)

120

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

Study Locations

  • Korea, Republic of
    • Gangwon-do
      • Wŏnju, Gangwon-do, Korea, Republic of, 26426
        • Recruiting
        • Wonju Severance Christian Hospital
        • Contact:

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

1 day to 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

newborn infants who were born and admitted on neonatal intensive care unit of Wonju Severance Christian Hospital

Description

Inclusion Criteria:

  • preterm infants who were born at gestational age of less than 36 weeks from approval date to Feb 28th 2019
  • full-term infants who were born at gestational age of greater than 37 weeks from approval date to Feb 28th 2019

Exclusion Criteria:

  • newborns with congenital anomaly
  • newborns with genetic syndrome
  • newborns without consent of parents

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
newborn infants were born with a gestational age of less than 32 weeks
Late preterm
newborn infants were born with a gestational age of greater than 32 weeks and less than 36 weeks
full-term
newborn infants were born with a gestational age of greater than or equal to 37 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal microbiome
Time Frame: for 2 years
The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment which is one of the analysis in result of metagenomics in each infants
for 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full Enteral feeding in preterm infants
Time Frame: for 2 years
Days to accomplish a full-enteral feeding in each infants
for 2 years
Growth rate
Time Frame: for 2 years
Days to reach 2 kg of body weight in each infants
for 2 years
Mortality
Time Frame: for 2 years
Number of patients who died in neonatal intensive care unit.
for 2 years
Morbidity
Time Frame: for 2 years
Number of patients who had a complication of preterm infants(e.g. necrotizing enterocolitis, bronchopulmonary dysplasia) or were died in neonatal intensive care unit.
for 2 years
Allergic predisposition
Time Frame: for 2 years
Number of patients who were developed a allergic predisposition at 6 month of postnatal age.
for 2 years

Collaborators and Investigators

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

Sponsor

Wonju Severance Christian Hospital

Investigators

  • Study Chair: Byoungkook Lee, Wonju Severance Christian 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)

July 25, 2017

Primary Completion (Anticipated)

February 28, 2019

Study Completion (Anticipated)

February 28, 2019

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 29, 2017

First Posted (Actual)

August 1, 2017

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 29, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • microbiome in nicu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes: There is a plan to make IPD and related data dictionaries available.

IPD Sharing Time Frame

starting from august 2017 until February 2019

IPD Sharing Access Criteria

neonatology pediatrics infections

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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