Metagenomic Analysis of Gut Microbiome in Preterm

• Conditions: Microbial Superinvasion; Newborn Morbidity; Microbial Colonization; Microbial Substitution

• Registration Number: NCT03235635
• Lead Sponsor: Wonju Severance Christian Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-17
• Study Start: 2017-07-25
• Study First Submitted QC: 2017-07-29
• Last Update Submitted: 2017-07-29
• Study First Posted: 2017-08-01
• Last Update Posted: 2017-08-01
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal microbiome	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

Secondary Outcome Measures

Name	Time	Method
Allergic predisposition	for 2 years	Number of patients who were developed a allergic predisposition at 6 month of postnatal age.
Mortality	for 2 years	Number of patients who died in neonatal intensive care unit.
Full Enteral feeding in preterm infants	for 2 years	Days to accomplish a full-enteral feeding in each infants
Growth rate	for 2 years	Days to reach 2 kg of body weight in each infants
Morbidity	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.

Trial Locations

Locations (1)

Wonju Severance Christian Hospital; 🇰🇷 Wŏnju, Gangwon-do, Korea, Republic of