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Metagenomic Analysis of Gut Microbiome in Preterm

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03235635
Acronym
MAGMP
Enrollment
120
Registered
2017-08-01
Start date
2017-07-25
Completion date
2019-02-28
Last updated
2017-08-01

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

Conditions

Microbial Colonization, Microbial Substitution, Microbial Superinvasion, Newborn Morbidity

Keywords

microbiome, preterm, newborn, gut microbiome, allergic predisposition

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.

Interventions

None listed

Sponsors

Wonju Severance Christian Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intestinal microbiomefor 2 yearsThe 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

MeasureTime frameDescription
Full Enteral feeding in preterm infantsfor 2 yearsDays to accomplish a full-enteral feeding in each infants
Growth ratefor 2 yearsDays to reach 2 kg of body weight in each infants
Mortalityfor 2 yearsNumber of patients who died in neonatal intensive care unit.
Morbidityfor 2 yearsNumber of patients who had a complication of preterm infants(e.g. necrotizing enterocolitis, bronchopulmonary dysplasia) or were died in neonatal intensive care unit.
Allergic predispositionfor 2 yearsNumber of patients who were developed a allergic predisposition at 6 month of postnatal age.

Countries

South Korea

Contacts

Primary ContactByoungkook Lee
raphael3067@gmail.com+82-10-6301-3067

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026