Metagenomic Analysis of Gut Microbiome in Preterm

Study Overview
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Brief Summary
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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
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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.

Official Title
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Metagenome Analysis of Intestinal Microbiome in Mortality and Morbidity of Preterm Infants

Conditions
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Microbial Colonization, Microbial Superinvasion, Microbial Substitution, Newborn Morbidity

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Day

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<br>newborn infants were born with a gestational age of less than 32 weeks | |
| Late preterm<br>newborn infants were born with a gestational age of greater than 32 weeks and less than 36 weeks | |
| full-term<br>newborn infants were born with a gestational age of greater than or equal to 37 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal microbiome | The distribution rate of intestinal microbiome of stool by K-mer based taxonomic assignment which is one of the analysis in result of metagenomics in each infants | for 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full Enteral feeding in preterm infants | Days to accomplish a full-enteral feeding in each infants | for 2 years | 
| Growth rate | Days to reach 2 kg of body weight in each infants | for 2 years | 
| Mortality | Number of patients who died in neonatal intensive care unit. | for 2 years | 
| Morbidity | Number of patients who had a complication of preterm infants(e.g. necrotizing enterocolitis, bronchopulmonary dysplasia) or were died in neonatal intensive care unit. | for 2 years | 
| Allergic predisposition | Number of patients who were developed a allergic predisposition at 6 month of postnatal age. | for 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, preterm, newborn, gut microbiome, allergic predisposition