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Search / Trial NCT06757582

Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up

Launched by UNIVERSITY HOSPITAL OF NORTH NORWAY · Jan 2, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

Necrotizing Enterocolitis Bowel Perforation Preterm Infant Long Term Follow Up Quality Of Life

ClinConnect Summary

This clinical trial is focused on understanding the long-term effects of surgery for two serious conditions in very preterm infants: necrotizing enterocolitis (NEC) and bowel perforation. NEC is a condition where parts of the intestines become inflamed and damaged, while bowel perforation is when there is a hole in the intestine. Both conditions can lead to surgery, and this study aims to explore how these surgeries affect the children as they grow, particularly in terms of their quality of life, growth, nutrition, and any ongoing digestive issues.

The trial is looking to include very preterm infants from Norway, born between 2008 and 2013, who were diagnosed with surgical NEC or bowel perforation and survived past their first year. For each child in the study, two other children with similar backgrounds will be invited to join as a comparison group. Participants' families can expect to contribute to important research that may help improve care and outcomes for future preterm infants facing these conditions. It’s important to note that families will need to provide consent for their child to participate in the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Case: All Norwegian very preterm infants (gestational age (GA) \< 32 weeks) born during the 6-year period 2008-2013, diagnosed with surgical NEC or bowel perforation and surviving up to one year of age will be invited to participate as cases.
  • Controls: For each case we will invite two controls matched for important clinical characteristics (e.g. sex, GA, clinical illness score, intracranial pathology, need for oxygen at discharge etc.).
  • Exclusion Criteria:
  • not signing informed consent scheme

About University Hospital Of North Norway

The University Hospital of North Norway (UNN) is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. As a key institution within the Norwegian health system, UNN combines cutting-edge medical practice with rigorous scientific inquiry, fostering collaboration among healthcare professionals, researchers, and academic partners. The hospital is committed to improving patient outcomes and enhancing the understanding of various health conditions through its extensive portfolio of clinical studies, which span multiple disciplines and focus on translating research findings into effective treatments and care strategies.

Locations

Tromsø, , Norway

Patients applied

0 patients applied

Trial Officials

Trond Flaegstad, MD, PhD

Study Director

University Hospital of North Norway

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported