Characterization of Intestinal Microbiota Stability in Preterm Born Neonates

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.

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Key information

Conditions

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

Age range

0 day–3 day

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zürich, Zurich, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Strain-level stability

Time frame: 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 outcomes

Source of bacterial species/strains

Time frame: 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

Sponsors and collaborators

Lead sponsor

Emma Marie Caroline Slack

Other

Collaborators

University Children's Hospital, Zurich
University of Zurich

Registry information

Official study title

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

Acronym: NEC

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Mar 11, 2021
Registry last updated: Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed