The Intestinal Innate Immune System in Newborns. Development and Inflammation in
Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: t
View:
⁃ 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.
Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
University hospital of sounthen denmark
RECRUITING
Odense
Contact Information
Primary
Lise Aunsholt, phd
lise.aunsholt@regionh.dk
+4561991137
Backup
Mark Bremholm Ellebæk, ph.d.
mark.ellebaek1@rsyd.dk
Time Frame
Start Date:2024-02-02
Estimated Completion Date:2029-10-30
Participants
Target number of participants:275
Treatments
Preterm infants
Infants will be included just after birth after obtained consent based on written and verbal information. Fecal samples will be collected from day 1 of life and weekly for the following weeks until discharge to investigate the composition of the fecal microbiome in relation to the development of NEC and the effect of medical therapy.~In case of development of NEC with the need for surgery the affected intestine will be resected and stomas will be established. Samples of fecal content and tissue is collected from intestine proximal and distal to divided intestine. At time of reversal of stomas, again tissue will be collected both proximal and distal from division to investigate the development of the intestine during early life as well as potential nutritional effects on intestinal maturity. Infants who do not undergo surgery serve as controls, those who are treated for NEC with antibiotics only, will be included in a sub analysis comparing the microbiome of infants who need surgery.
Newborn and children up to 1 year of age
Infants with congenital malformations will have to undergo scheduled surgery to resect and/or anastomose the affected area of the intestine and some will receive a stoma that needs later reversal. At primary surgery fecal 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.