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Clinical Trials in Denmark / NCT06092463
Recruiting Observational

The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease

NCT06092463 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Observational
Started
2024-02-02
Last updated
2025-05-21

Condition(s) studied

Preterm InfantsTerm InfantsNecrotising EnterocolitisAtresia; BowelInnate Inflammatory Response

Study 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-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).

Eligibility

Sex
ALL
Min age
—
Max age
1 Year
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • If faecal IgA may be an early marker of NEC in preterm infants — 6 years
    IgA measures in repetative faecal samples from admission till disease or GA 34 weeks in no-NEC infants
  • Development of the intestinal immune system over time — 6 years
    mRNA sequencing of intestinal tissue from preterm infants exposed to surgery due to NEC and compared to intestinal tissue removed from term infants undergoing surgery due to atresia.

Trial sites (2)

FacilityCityRegionStatus
Rigshospitalet Copenhagen Denmark Recruiting
University hospital of sounthen denmark Odense Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06092463 on ClinicalTrials.gov ↗ ← All trials in Denmark