Clinical trial NCT03841994: Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants
Official title: Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infants
Keywords: microbiome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 47
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants who are born at \< 28 weeks of gestation and admitted to the neonatal intensive care unit at Seoul national university children's hospital

Brief summary: A prospective cohort study investigating the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

Detailed description: The purpose of this study was to investigate the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

Eligibility criteria: Inclusion Criteria:

* Preterm infants
* born less than 28+0 weeks gestation

Exclusion Criteria:

* Major congenital anomalies

Primary outcomes:
measure: The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment
timeFrame: within 24 hours after birth
measure: The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment
timeFrame: 2 weeks after birth
measure: The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment
timeFrame: 3~5 weeks after birth
measure: The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment
timeFrame: at 37~40 weeks of postmenstrual age
Secondary outcomes:
measure: Brain MRI
timeFrame: at 37~40 weeks of postmenstrual age
measure: Bayley scales of infant and toddler development, third edition
timeFrame: at 18~24 months of corrected age
measure: Incidence of major morbidity
timeFrame: at 36~40 weeks of postmenstrual age
measure: Comparison of inflammation markers
timeFrame: with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age
measure: Comparison of short chain fatty acid at 4 period
timeFrame: with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ee-Kyung Kim, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Choi Y, Kwon Y, Kim DK, Jeon J, Jang SC, Wang T, Ban M, Kim MH, Jeon SG, Kim MS, Choi CS, Jee YK, Gho YS, Ryu SH, Kim YK. Gut microbe-derived extracellular vesicles induce insulin resistance, thereby impairing glucose metabolism in skeletal muscle. Sci Rep. 2015 Oct 29;5:15878. doi: 10.1038/srep15878.
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citation: Sung J, Kim N, Kim J, Jo HJ, Park JH, Nam RH, Seok YJ, Kim YR, Lee DH, Jung HC. Comparison of Gastric Microbiota Between Gastric Juice and Mucosa by Next Generation Sequencing Method. J Cancer Prev. 2016 Mar;21(1):60-5. doi: 10.15430/JCP.2016.21.1.60. Epub 2016 Mar 30.
citation: Yoo JY, Rho M, You YA, Kwon EJ, Kim MH, Kym S, Jee YK, Kim YK, Kim YJ. 16S rRNA gene-based metagenomic analysis reveals differences in bacteria-derived extracellular vesicles in the urine of pregnant and non-pregnant women. Exp Mol Med. 2016 Feb 5;48(2):e208. doi: 10.1038/emm.2015.110.
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