Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

Completed

• Conditions: Necrotising Enterocolitis; Late-Onset Neonatal Sepsis

• Registration Number: NCT04792918
• Lead Sponsor: Emma Marie Caroline Slack

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-02-11
• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-11
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Strain-level stability	24 months	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

Secondary Outcome Measures

Name	Time	Method
Source of bacterial species/strains	24 months	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

Trial Locations

Locations (2)

University Hospital Zürich; 🇨🇭 Zürich, Switzerland

University Children's Hospital Zürich; 🇨🇭 Zürich, Switzerland