Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

Late-Onset Neonatal Sepsis Clinical Trial

— NEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792918
• Other study ID #: NEC
• Status: Completed
• Start date: February 11, 2021
• Est. completion date: June 20, 2023

Study information

• Verified date: July 2023
• Source: ETH Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Late-Onset Neonatal Sepsis
• Necrotising Enterocolitis
• Neonatal Sepsis

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zürich	Zürich
Switzerland	University Hospital Zürich	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
Emma Marie Caroline Slack	University Children's Hospital, Zurich, University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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