Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

Study Overview
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Brief Summary
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Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS). Collection of stool and other biological samples to assess the strain-level stability of gastrointestinal microbiota in these preterm infants who may or may not develop NEC/LOS.

Detailed Description
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This study aims to collect biological samples (stool, stomach fluid, and blood) from preterm infants at risk of developing NEC or LOS; as well as environmental samples from infants' hospital surroundings (swabs, air), nutritional intake (formula, breastmilk) and samples from their family members (faeces, vaginal swab). The main focus of the study is to assess strain-level stability of gastrointestinal microbiota in these infants and potentially assess the source of disease-causing microbiota species/strains.

Official Title
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Intestinal Microbiome Strain-level Stability in NEC/ or LOS Patients

Conditions
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Necrotising Enterocolitis, Late-Onset Neonatal Sepsis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Preterm infants with a gestational age < 32 weeks or a birthweight < 1500g and their family members Exclusion Criteria: Intestinal atresia Live born infants referred to from other hospitals later than 3 days after birth

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 3 Days

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 |
| --- | --- |
| NEC/LOS preterm infants<br>Collection of biological samples (stool, stomach fluid, blood) and health-related data over the first few weeks of life, additional stool samples after onset of NEC/LOS | |
| Preterm infants not developing NEC/LOS<br>Collection of biological samples (stool, stomach fluid, blood) and health-related data over the first few weeks of life | |
| Family members of preterm infants<br>Collection of biological samples (stool, breastmilk, vaginal swab) and health-related data at one timepoint after the birth of the preterm infant from members of the family (mother, father) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strain-level stability | Identify members of the gastrointestinal microbiota (species/strains) that are associated with development of NEC or LOS in very-low birthweight/very preterm Identify members of the gastrointestinal microbiota (species/strains) that are associated with development of NEC or LOS in very-low birthweight/very preterm infants via changes in frequencies, absolute colonization levels, or temporal stability | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Source of bacterial species/strains | Quantify genetic similarity between potentially disease-causing microbiota strains found within NEC/LOS patients and within family members (faeces, breastmilk, vaginal swab) and hospital surroundings | 24 months |