Status:
RECRUITING
The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Technical University of Denmark
Odense University Hospital
Conditions:
Preterm Infants
Term Infants
Eligibility:
All Genders
Up to 1 years
Brief 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...
Detailed Description
1\. NEC Study 1.1. Inclusion criteria Premature infants born \< GA week 32. The total number to be included will be 200 1.2. Exclusion criteria Premature born with congenital diseases or other serious...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2029
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT06092463
Start Date
February 2 2024
End Date
October 30 2029
Last Update
May 21 2025
Active Locations (2)
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1
Rigshospitalet
Copenhagen, Denmark, 2100
2
University hospital of sounthen denmark
Odense, Denmark