Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants
23. maj 2022 opdateret af: Ee-Kyung Kim, Seoul National University Hospital
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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
47
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ee-Kyung Kim, M.D., PhD.
- Telefonnummer: +82220723628
- E-mail: kimek@snu.ac.kr
Studiesteder
-
-
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Seoul, Korea, Republikken
- Rekruttering
- Seoul National University Hospital
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Kontakt:
- Seung Han Shin, MD
- Telefonnummer: +82220727230
- E-mail: revival421@snu.ac.kr
-
Kontakt:
- Ee-Kyung Kim, MD
- Telefonnummer: +8220723628
- E-mail: kimek@snu.ac.kr
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 6 måneder (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
Inclusion Criteria:
- Preterm infants
- born less than 28+0 weeks gestation
Exclusion Criteria:
- Major congenital anomalies
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Preterm infant cohort
Preterm infants who were born <28 weeks of gestational age
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment
Tidsramme: within 24 hours after birth
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Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice
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within 24 hours after birth
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The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment
Tidsramme: 2 weeks after birth
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Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice
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2 weeks after birth
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The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment
Tidsramme: 3~5 weeks after birth
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Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice
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3~5 weeks after birth
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The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment
Tidsramme: at 37~40 weeks of postmenstrual age
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Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice
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at 37~40 weeks of postmenstrual age
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Brain MRI
Tidsramme: at 37~40 weeks of postmenstrual age
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white matter injury
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at 37~40 weeks of postmenstrual age
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Bayley scales of infant and toddler development, third edition
Tidsramme: at 18~24 months of corrected age
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For neurodevelopmental screening, Bayley scales of infant and toddler development, third edition yields composite scores for each cognitive, language, motor. It is considered normal when >85. Developmental delay is diagnosed when the mean result is below 85. Neurodevelopmental screening is considered normal when a child achieves these all. |
at 18~24 months of corrected age
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Incidence of major morbidity
Tidsramme: at 36~40 weeks of postmenstrual age
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Major morbidity such as bronchopulmonary dysplasia, periventricular leukomalacia, retinopathy of prematurity
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at 36~40 weeks of postmenstrual age
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Comparison of inflammation markers
Tidsramme: with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age
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Comparison of inflammation markers such as Interleukin(IL)-1 beta/IL-1F2, IL-6, IL-8/CXCL8, Tumor necrosis factor(TNF)-alpha, etc.
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with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age
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Comparison of short chain fatty acid at 4 period
Tidsramme: with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age
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Comparison of short chain fatty acid in stool and blood at 4 period
|
with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Ee-Kyung Kim, M.D., PhD., Seoul National University Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12.
- Stewart CJ, Embleton ND, Marrs EC, Smith DP, Nelson A, Abdulkadir B, Skeath T, Petrosino JF, Perry JD, Berrington JE, Cummings SP. Temporal bacterial and metabolic development of the preterm gut reveals specific signatures in health and disease. Microbiome. 2016 Dec 29;4(1):67. doi: 10.1186/s40168-016-0216-8.
- Rea K, Dinan TG, Cryan JF. The microbiome: A key regulator of stress and neuroinflammation. Neurobiol Stress. 2016 Mar 4;4:23-33. doi: 10.1016/j.ynstr.2016.03.001. eCollection 2016 Oct.
- Cao B, Stout MJ, Lee I, Mysorekar IU. Placental Microbiome and Its Role in Preterm Birth. Neoreviews. 2014 Dec 1;15(12):e537-e545. doi: 10.1542/neo.15-12-e537.
- 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.
- Cong X, Henderson WA, Graf J, McGrath JM. Early Life Experience and Gut Microbiome: The Brain-Gut-Microbiota Signaling System. Adv Neonatal Care. 2015 Oct;15(5):314-23; quiz E1-2. doi: 10.1097/ANC.0000000000000191.
- DiBartolomeo ME, Claud EC. The Developing Microbiome of the Preterm Infant. Clin Ther. 2016 Apr;38(4):733-9. doi: 10.1016/j.clinthera.2016.02.003. Epub 2016 Mar 2.
- Kim MH, Rho M, Choi JP, Choi HI, Park HK, Song WJ, Min TK, Cho SH, Cho YJ, Kim YK, Yang S, Pyun BY. A Metagenomic Analysis Provides a Culture-Independent Pathogen Detection for Atopic Dermatitis. Allergy Asthma Immunol Res. 2017 Sep;9(5):453-461. doi: 10.4168/aair.2017.9.5.453.
- Macfabe DF. Short-chain fatty acid fermentation products of the gut microbiome: implications in autism spectrum disorders. Microb Ecol Health Dis. 2012 Aug 24;23. doi: 10.3402/mehd.v23i0.19260. eCollection 2012.
- Mshvildadze M, Neu J. The infant intestinal microbiome: friend or foe? Early Hum Dev. 2010 Jul;86 Suppl 1(Suppl 1):67-71. doi: 10.1016/j.earlhumdev.2010.01.018. Epub 2010 Feb 8. Erratum In: Early Hum Dev. 2014 Mar;90(3):163-4.
- Murgas Torrazza R, Neu J. The developing intestinal microbiome and its relationship to health and disease in the neonate. J Perinatol. 2011 Apr;31 Suppl 1:S29-34. doi: 10.1038/jp.2010.172.
- Sanz Y. Gut microbiota and probiotics in maternal and infant health. Am J Clin Nutr. 2011 Dec;94(6 Suppl):2000S-2005S. doi: 10.3945/ajcn.110.001172. Epub 2011 May 4.
- 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.
- 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.
- Wang X, Buhimschi CS, Temoin S, Bhandari V, Han YW, Buhimschi IA. Comparative microbial analysis of paired amniotic fluid and cord blood from pregnancies complicated by preterm birth and early-onset neonatal sepsis. PLoS One. 2013;8(2):e56131. doi: 10.1371/journal.pone.0056131. Epub 2013 Feb 20.
- Ardissone AN, de la Cruz DM, Davis-Richardson AG, Rechcigl KT, Li N, Drew JC, Murgas-Torrazza R, Sharma R, Hudak ML, Triplett EW, Neu J. Meconium microbiome analysis identifies bacteria correlated with premature birth. PLoS One. 2014 Mar 10;9(3):e90784. doi: 10.1371/journal.pone.0090784. eCollection 2014. Erratum In: PLoS One. 2014;9(6):e101399.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
4. december 2018
Primær færdiggørelse (Forventet)
28. februar 2023
Studieafslutning (Forventet)
28. februar 2023
Datoer for studieregistrering
Først indsendt
1. februar 2019
Først indsendt, der opfyldte QC-kriterier
12. februar 2019
Først opslået (Faktiske)
15. februar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1801-128-917
Plan for individuelle deltagerdata (IPD)
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