Understanding the intestinal immune system in newborns and its role in gastrointestinal diseases
The Intestinal Innate Immune System in Newborns. Development and Inflammation in
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 |
|---|---|
| Enrollment | 275 (estimated) |
| Ages | N/A to 1 Year |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 2 sites (Copenhagen and 1 other locations) |
| Trial ID | NCT06092463 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Copenhagen and 1 other locations
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- University hospital of sounthen denmark — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Lise Aunsholt, ph.d. — Rigshospitalet, Denmark
- Study coordinator: Lise Aunsholt, phd
- Email: lise.aunsholt@regionh.dk
- Phone: +4561991137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.