Actively Recruiting
The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
Led by Rigshospitalet, Denmark · Updated on 2025-05-21
275
Participants Needed
2
Research Sites
299 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
T
Technical University of Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premature infants born before 32 weeks of gestation (NEC study)
- Newborns and children up to 1 year of age who require intestinal surgery due to atresia at any site of the intestine
You will not qualify if you...
- Premature infants with congenital diseases or other serious conditions that may prevent participation
- Situations where tissue collection during surgery is impossible or unsafe due to insufficient remaining vital intestine
- Infants and children where intestinal tissue sampling would compromise surgery or the patient's health
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
2
University hospital of sounthen denmark
Odense, Denmark
Actively Recruiting
Research Team
L
Lise Aunsholt, phd
CONTACT
M
Mark Bremholm Ellebæk, ph.d.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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