NCT06092463 The Intestinal Innate Immune System in Newborns. Development and Inflammation in Health and Disease
| NCT ID | NCT06092463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Preterm Infants |
| Study Type | OBSERVATIONAL |
| Enrollment | 275 participants |
| Start Date | 2024-02-02 |
| Primary Completion | 2029-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 275 participants in total. It began in 2024-02-02 with a primary completion date of 2029-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Lise Aunsholt, ph.d.
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT06092463 clinical trial?
This trial is open to participants of all sexes, up to 1 Year, studying Preterm Infants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06092463 currently recruiting?
Yes, NCT06092463 is actively recruiting participants. Contact the research team at lise.aunsholt@regionh.dk for enrollment information.
Where is the NCT06092463 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Odense, Denmark.
Who is sponsoring the NCT06092463 clinical trial?
NCT06092463 is sponsored by Rigshospitalet, Denmark. The principal investigator is Lise Aunsholt, ph.d. at Rigshospitalet, Denmark. The trial plans to enroll 275 participants.