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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 1
SponsorRigshospitalet, Denmark

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

275 Participants
are grouped into 2 trial groups
Group A: Preterm infants
Group B: Newborn and children up to 1 year of age

Trial outcomes

Primary outcomes

1

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

Time frame
6 years
2

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.

Time frame
6 years

Secondary outcomes

1

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.

Time frame
6 years
2

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

Time frame
6 years

Other outcomes

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