Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

NCT04792918 | Completed

• 1 other identifier: NEC
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 2

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.

Conditions

Necrotising Enterocolitis; Late-Onset Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Source of bacterial species/strains

  24 months

Study Arms (3)

NEC/LOS preterm infants

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

Collection of biological samples (stool, stomach fluid, blood) and health-related data over the first few weeks of life

Family members of preterm infants

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)

Eligibility Criteria

• Age: 0 Days - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population is represented by infants born at gestational age below 32 weeks (very preterm born infants) or with a birthweight below 1500g (very low birthweight infants). It is estimated that approximately 100 infants will be enrolled during the study period. As the aim is to study stability of the premature microbiota within individual patients, the study design precludes the need of control groups.

You may qualify if:

• Preterm infants with a gestational age \< 32 weeks or a birthweight \< 1500g and their family members

You may not qualify if:

• Intestinal atresia
• Live born infants referred to from other hospitals later than 3 days after birth

Sponsors & Collaborators

• Emma Marie Caroline Slack: lead
• University of Zurich: collaborator
• University Children's Hospital, Zurich: collaborator

Study Sites (2)

University Children's Hospital Zürich

Zurich, 8032, Switzerland

Location

University Hospital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Neonatal Sepsis

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 11, 2021
• Study Start: February 11, 2021
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)