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Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants

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ClinicalTrials.gov Identifier: NCT03841994
Recruitment Status : Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ee-Kyung Kim, Seoul National University 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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : December 4, 2024



Primary Outcome Measures :
  1. The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment [ Time Frame: within 24 hours after birth ]
    Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice

  2. The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment [ Time Frame: 2 weeks after birth ]
    Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice

  3. The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment [ Time Frame: 3~5 weeks after birth ]
    Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice

  4. The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment [ Time Frame: at 37~40 weeks of postmenstrual age ]
    Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice


Secondary Outcome Measures :
  1. Brain MRI [ Time Frame: at 37~40 weeks of postmenstrual age ]
    white matter injury

  2. Bayley scales of infant and toddler development, third edition [ Time Frame: at 18~24 months of corrected age ]

    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.


  3. Incidence of major morbidity [ Time Frame: at 36~40 weeks of postmenstrual age ]
    Major morbidity such as bronchopulmonary dysplasia, periventricular leukomalacia, retinopathy of prematurity

  4. Comparison of inflammation markers [ Time Frame: with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age ]
    Comparison of inflammation markers such as Interleukin(IL)-1 beta/IL-1F2, IL-6, IL-8/CXCL8, Tumor necrosis factor(TNF)-alpha, etc.

  5. Comparison of short chain fatty acid at 4 period [ Time Frame: with in 24 hours after birth, in 2 weeks, in 3~5 weeks, at 37~40 weeks of postmenstrual age ]
    Comparison of short chain fatty acid in stool and blood at 4 period


Biospecimen Retention:   Samples Without DNA
gastric juice, blood, stool, breast milk, transtracheal aspirates


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Major congenital anomalies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841994


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital

Publications of Results:
Other Publications:

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Responsible Party: Ee-Kyung Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03841994     History of Changes
Other Study ID Numbers: 1801-128-917
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ee-Kyung Kim, Seoul National University Hospital:
microbiome

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications