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
N/A
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
Researchers are investigating how the human intestinal immune system develops in both premature and mature newborns and exploring the causes of serious early-life gastrointestinal diseases such as necrotising enterocolitis (NEC) and intestinal atresia. This observational study aims to understand the normal immune development in newborns and how it relates to early feeding practices during the neonatal period. The study includes two groups: premature infants born before 32 weeks gestation and newborns or children up to 1 year old undergoing intestinal surgery for atresia. For premature infants, fecal samples are collected starting from day 1 of life weekly until discharge. If NEC develops requiring surgery, intestinal tissue and fecal samples are obtained during surgery and at stoma reversal to study intestinal development and nutritional effects. Similarly, for infants with atresia, fecal and tissue samples are collected during surgery and later stoma reversal when applicable. Participants and their families will provide fecal samples regularly, and, when surgery is needed, intestinal tissue samples will be collected safely. Researchers will analyze immune system development and microbiome changes over time using these samples. Primary outcomes include studying if fecal IgA can be an early NEC marker and tracking intestinal immune system development. Secondary outcomes consider nutritional impact, growth, medical treatments, and bowel habits. Participation involves informed consent, sample collection, and monitoring throughout the infant's hospital stay or surgical course, lasting up to one year for some participants.
CONDITIONS
Brief 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 gestation for the NEC study
- Newborns and children up to 1 year old needing intestinal surgery due to atresia
You will not qualify if you...
- Premature infants with congenital diseases or other serious conditions that may prevent participation
- Cases where tissue collection during surgery is impossible or unsafe due to short remaining intestine
- Infants and children where tissue sampling would compromise surgery or health
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From birth or surgery until discharge, up to several weeks
Participants are observed with weekly fecal sample collections to study the intestinal microbiome development and immune system over time, including those who do not undergo surgery.
Weekly visits for sample collection until discharge
Duration - Duration of hospital stay for surgery and immediate recovery
Participants who require surgery have intestinal tissue and fecal samples collected during primary surgery and stoma reversal to investigate intestinal development and immune response.
1 primary surgery visit and 1 stoma reversal visit (if applicable)
Duration - Up to 6 years
Participants are followed over time to assess intestinal immune system development and nutritional impact, with ongoing sample collection and clinical assessments.
Follow-up visits scheduled over several years as per clinical protocol
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
M
Mark Bremholm Ellebæk, ph.d.
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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