Clinical trial NCT03235635: Metagenomic Analysis of Gut Microbiome in Preterm
Official title: Metagenome Analysis of Intestinal Microbiome in Mortality and Morbidity of Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbial Colonization
Microbial Superinvasion
Microbial Substitution
Newborn Morbidity
Keywords: microbiome
preterm
newborn
gut microbiome
allergic predisposition
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborn infants who were born and admitted on neonatal intensive care unit of 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intestinal microbiome
timeFrame: for 2 years
Secondary outcomes:
measure: Full Enteral feeding in preterm infants
timeFrame: for 2 years
measure: Growth rate
timeFrame: for 2 years
measure: Mortality
timeFrame: for 2 years
measure: Morbidity
timeFrame: for 2 years
measure: Allergic predisposition
timeFrame: for 2 years
Other outcomes:
Locations:
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
Study officials:
affiliation: Wonju Severance Christian Hospital
name: Byoungkook Lee
role: STUDY_CHAIR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.