Characterization of Intestinal Microbiota Stability in Preterm Born Neonates (NEC)

Emma Marie Caroline Slack

Status: Completed

Conditions: Necrotising Enterocolitis; Late-Onset Neonatal Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT04792918

NEC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: Under 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

81 participants in 3 patient groups

NEC/LOS preterm infants

Description:

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

Description:

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

Family members of preterm infants

Description:

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)