Understanding the intestinal immune system in newborns and its role in gastrointestinal diseases
Official title: The Intestinal Innate Immune System in Newborns. Development and Inflammation in
Run by Copenhagen University Hospital, Rigshospitalet · NCT06092463 · Data updated 2026-11-12
This study looks at how the immune system in newborns develops and how it relates to serious gut problems like NEC and bowel atresia, by collecting samples from both preterm and term infants.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 1 Year |
| Sex | All |
| Enrollment | 275 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Status | Recruiting |
| Started | February 2, 2024 |
| Main results expected | October 30, 2029 |
| Study ends | October 30, 2029 |
| Registry record updated | May 21, 2025 |
| Trial ID | NCT06092463 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include premature infants born before 32 weeks of gestation and newborns up to one year old requiring intestinal surgery due to atresia.
✕Probably not a fit
Patients with congenital diseases or serious conditions that may complicate participation or those where tissue sampling could jeopardize their health will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the normal development of the intestinal immune system in both preterm and term infants, focusing on the pathophysiology of severe gastrointestinal diseases like necrotizing enterocolitis (NEC) and bowel atresia. Participants will provide fecal samples starting from day one of life and weekly thereafter until discharge, allowing researchers to analyze the microbiome's composition and its relationship with enteral nutrition. Additionally, tissue samples will be collected during surgeries for NEC or atresia to further investigate intestinal development and the effects of nutrition on maturity.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of gastrointestinal diseases in newborns, potentially reducing morbidity and mortality rates.
How similar studies have gone: While this study addresses a critical area of neonatal health, similar studies have shown promise in understanding the intestinal immune system, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Rigshospitalet
Copenhagen, Denmark Recruiting -
University hospital of sounthen denmark
Odense, Denmark Recruiting
Study contacts
- Principal investigator: Lise Aunsholt, ph.d. — Copenhagen University Hospital, Rigshospitalet
- Study coordinator: Lise Aunsholt, phd
- Email: lise.aunsholt@regionh.dk
- Phone: +4561991137
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.