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

Recruitingn/aAges any - 1 YearAllCopenhagen University Hospital, Rigshospitalet
NCT06092463 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pa

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

2 sites
Rigshospitalet
Copenhagen, Denmark
University hospital of sounthen denmark
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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