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NCT06092463: INTINE
The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
trial in Preterm Infants in 275 participants. Currently enrolling.
30 October 2029
Quick facts
| Lead sponsor | Rigshospitalet, Denmark |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 275 |
| Start date | 2 February 2024 |
| Primary completion | 30 October 2029 |
| Estimated completion | 30 October 2029 |
| Sites | 2 locations across Denmark |
Conditions studied
- Preterm Infants — all drugs for Preterm Infants →
- Term Infants — all drugs for Term Infants →
- Necrotising Enterocolitis — all drugs for Necrotising Enterocolitis →
- Atresia; Bowel — all drugs for Atresia; Bowel →
Sponsor
Rigshospitalet, Denmark
Who can join
Under 1, any sex, with Preterm Infants or Term Infants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06092463
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Rigshospitalet, Denmark trials
Trials by the same sponsor.
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- NCT07442357 — The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial · NA · not yet recruiting
- NCT07528729 — Alcohol as a Modifiable Risk Factor for Atrial Fibrillation · NA · not yet recruiting
- NCT07511439 — Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission · Phase 4 · not yet recruiting
- NCT07467187 — Invasive Home Ventilation in Denmark · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06092463 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rigshospitalet, Denmark
- Last refreshed: 21 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06092463.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing