About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Preterm infants and children up to 1 year of age
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
If faecal IgA may be an early marker of NEC in preterm infants
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
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.
Secondary outcomes
Nutritional impact on intestinal development
Comparison of tissue removed at primary surgery in preterm with NEC and at later stomareversal. measurements are:Growth in kg, type of nutrition (MOM, DHM or Formula), number of days on TPN, number of days with central venous catheter and medical treatment.
Bowel habits in preterm infants as marker for later intestinal disease
Comparison of meconium passage (measured in hours), faecal scores (using Amsterdam stool scale) and use of laxative (prescription day, number of days, and type of laxative) in preterm who remain intestinal healthy to those who develop medical and surgical NEC or SIP
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Technical University of Denmark
Collaborator
Odense University Hospital
Collaborator