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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preterm Infants

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants born less than 28+0 weeks gestation Exclusion Criteria: Major congenital anomalies

Ages Eligible for Study
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Maximum Age: 28 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm infant cohort<br>Preterm infants who were born <28 weeks of gestational age | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment | Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice | within 24 hours after birth | 
| The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment | Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice | 2 weeks after birth | 
| The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment | Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice | 3 5 weeks after birth | 
| The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment | Comparison of gut microbiome with 16s RNA gene specific sequencing in stool, breast milk, gastric juice | at 37 40 weeks of postmenstrual age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain MRI | white matter injury | at 37 40 weeks of postmenstrual age | 
| Bayley scales of infant and toddler development, third edition | 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 | 
| Incidence of major morbidity | Major morbidity such as bronchopulmonary dysplasia, periventricular leukomalacia, retinopathy of prematurity | at 36 40 weeks of postmenstrual age | 
| Comparison of inflammation markers | Comparison of inflammation markers such as Interleukin(IL)-1 beta/IL-1F2, IL-6, IL-8/CXCL8, Tumor necrosis factor(TNF)-alpha, etc. | 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 at 4 period | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome