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RECRUITING
NCT06092463

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

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

Summary

The goal of this observational study is to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal diseases that appear during early life. The main questions aim to answer are: * to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal diseases that appear during early life. * is to investigate the development of the immune system in relation to enteral nutrition during the neonatal period. Participants will be asked to give faecal samples from day 1 of life and weekly for the following weeks until discharge (preterm infants). Further, surgery faecal samples and intestinal tissue will be collected proximal and distal to the pathology. In cases with a stoma, and when the child will undergo later reversal surgery, tissue samples from the proximal and distal ends of the intestine will be collected together with fecal samples (preterm and children up to 1 year of age who need to undergo intestinal surgery due to atresia).

Official title: The Intestinal Innate Immune System in Newborns. Development and Inflammation in

Key Details

Gender

All

Age Range

Any - 1 Year

Study Type

OBSERVATIONAL

Enrollment

275

Start Date

2024-02-02

Completion Date

2029-10-30

Last Updated

2025-05-21

Healthy Volunteers

Yes

Locations (2)

Rigshospitalet

Copenhagen, Denmark

University hospital of sounthen denmark

Odense, Denmark