The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease

Launched by RIGSHOSPITALET, DENMARK · Oct 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system in the intestines develops in newborns, both those born prematurely (before 32 weeks) and those born at full term. Researchers want to learn about the normal growth of this immune system and how it might be linked to serious gastrointestinal (digestive) problems that can occur in young babies, such as necrotizing enterocolitis (a dangerous condition that affects the intestines) and bowel atresia (a condition where part of the intestine is missing or not formed properly). The study will also look at how feeding these infants affects their immune development.

To participate in the study, infants must either be preterm babies born before 32 weeks or children up to 1 year old who need surgery for bowel atresia. During the trial, participants will provide stool samples starting from their first day of life and continuing weekly until they go home. For those who have surgery, additional tissue samples from the intestines will be collected. It's important to note that babies with certain congenital diseases or conditions that could complicate surgery might not be eligible. This trial aims to improve our understanding of how to support the health of newborns as they grow.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • NEC study
• • Premature infants born \< GA week 32 Atresia study
• • All newborn and children up to 1 year of age who needs to undergo intestinal surgery due to atresia at any site of the intestine.
• Exclusion Criteria:
• • NEC study - Premature born with congenital diseases or other serious conditions which may defer participation. Situations where collection of tissue at surgery is impossible or problematic e.g. due to remaining length of vital intestine is evaluated to be too short according to the discretion of the operating surgeon.
• • Atresia study
• • -Infants and children where intestinal tissue sampling would compromise surgery and the health of the patient subsequent.