Metagenomic Analysis of Gut Microbiome in Preterm

NCT03235635 | Unknown DMC

• 1 other identifier: microbiome in nicu
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization; Microbial Superinvasion; Microbial Substitution; Newborn Morbidity

Keywords

microbiome; preterm; newborn; gut microbiome; allergic predisposition

Outcome Measures

Primary Outcomes (1)

• Intestinal microbiome

  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 Outcomes (5)

• Full Enteral feeding in preterm infants

  for 2 years

• Growth rate

  for 2 years

• Mortality

  for 2 years

• Morbidity

  for 2 years

• Allergic predisposition

  for 2 years

Study Arms (3)

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

Eligibility Criteria

• Age: 1 Day - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Related Publications (8)

• Rautava S. Microbial Composition of the Initial Colonization of Newborns. Nestle Nutr Inst Workshop Ser. 2017;88:11-21. doi: 10.1159/000455209. Epub 2017 Mar 27.

  PMID: 28346920 RESULT

• Butel MJ, Suau A, Campeotto F, Magne F, Aires J, Ferraris L, Kalach N, Leroux B, Dupont C. Conditions of bifidobacterial colonization in preterm infants: a prospective analysis. J Pediatr Gastroenterol Nutr. 2007 May;44(5):577-82. doi: 10.1097/MPG.0b013e3180406b20.

  PMID: 17460489 RESULT

• Turnbaugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI. The human microbiome project. Nature. 2007 Oct 18;449(7164):804-10. doi: 10.1038/nature06244.

  PMID: 17943116 RESULT

• Jacquot A, Neveu D, Aujoulat F, Mercier G, Marchandin H, Jumas-Bilak E, Picaud JC. Dynamics and clinical evolution of bacterial gut microflora in extremely premature patients. J Pediatr. 2011 Mar;158(3):390-6. doi: 10.1016/j.jpeds.2010.09.007. Epub 2010 Oct 18.

  PMID: 20961563 RESULT

• Arboleya S, Binetti A, Salazar N, Fernandez N, Solis G, Hernandez-Barranco A, Margolles A, de Los Reyes-Gavilan CG, Gueimonde M. Establishment and development of intestinal microbiota in preterm neonates. FEMS Microbiol Ecol. 2012 Mar;79(3):763-72. doi: 10.1111/j.1574-6941.2011.01261.x. Epub 2011 Dec 15.

  PMID: 22126419 RESULT

• Johnson CL, Versalovic J. The human microbiome and its potential importance to pediatrics. Pediatrics. 2012 May;129(5):950-60. doi: 10.1542/peds.2011-2736. Epub 2012 Apr 2.

  PMID: 22473366 RESULT

• McElroy SJ, Weitkamp JH. Innate Immunity in the Small Intestine of the Preterm Infant. Neoreviews. 2011 Sep 1;12(9):e517-e526. doi: 10.1542/neo.12-9-e517.

  PMID: 22639551 RESULT

• Groer MW, Luciano AA, Dishaw LJ, Ashmeade TL, Miller E, Gilbert JA. Development of the preterm infant gut microbiome: a research priority. Microbiome. 2014 Oct 13;2:38. doi: 10.1186/2049-2618-2-38. eCollection 2014.

  PMID: 25332768 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

extraction microbiome DNA from stool of newborns

MeSH Terms

Conditions

Communicable Diseases; Superinfection; Premature Birth

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Opportunistic Infections; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Byoungkook Lee

  Wonju Severance Christian Hospital

  STUDY CHAIR

Central Study Contacts

Byoungkook Lee

CONTACT

+82-10-6301-3067; raphael3067@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: August 1, 2017
• Study Start: July 25, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting from august 2017 until February 2019
• Access Criteria: neonatology pediatrics infections

Locations

KR (1)