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

NCT06092463 | Recruiting

• 1 other identifier: S-20220057
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 2

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).

Conditions

Preterm Infants; Term Infants; Necrotising Enterocolitis; Atresia; Bowel; Innate Inflammatory Response

Keywords

IgA; mRNA sequencing; Nutritional support; Bowel habbits

Outcome Measures

Primary Outcomes (2)

• 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

  6 years

• 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.

  6 years

Secondary Outcomes (2)

• Nutritional impact on intestinal development

  6 years

• Bowel habits in preterm infants as marker for later intestinal disease

  6 years

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants and children up to 1 year of age

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Technical University of Denmark: collaborator
• Odense University Hospital: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

University hospital of sounthen denmark

Odense, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

faecal material and intestinal tissue

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Intestinal Atresia; Inflammation

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lise Aunsholt, ph.d.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Aunsholt, phd

CONTACT

+4561991137; lise.aunsholt@regionh.dk

Mark Bremholm Ellebæk, ph.d.

CONTACT

mark.ellebaek1@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior consultant, Ph.D., Associate Professor

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 23, 2023
• Study Start: February 2, 2024
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): October 30, 2029
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)