Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

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Brief Title

Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

Official Title

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

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, urine, 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 Type

Observational [Patient Registry]


Primary Outcome

Strain-level stability

Secondary Outcome

 Source of bacterial species/strains

Condition

Necrotising Enterocolitis


Study Arms / Comparison Groups

 NEC/LOS preterm infants
Description:  Collection of biological samples (stool, stomach fluid, blood, urine) and health-related data over the first few weeks of life, additional stool samples after onset of NEC/LOS

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

100

Start Date

February 11, 2021

Completion Date

February 2025

Primary Completion Date

February 2023

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - 3 Days

Accepts Healthy Volunteers

No

Contacts

, +41 44 632 45 91, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT04792918

Organization ID

NEC


Responsible Party

Sponsor-Investigator

Study Sponsor

Emma Marie Caroline Slack

Collaborators

 University of Zurich

Study Sponsor

, , 


Verification Date

March 2021