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

NCT06757582 | Not Yet Recruiting

• 1 other identifier: 2018/1976/REK nord
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall. Some preterm infants also develop spontaneous intestinal perforations (SIP) without the classical bowel inflammation/necrosis seen in NEC. NEC and SIP can be challenging to differentiate. Severe cases of both conditions require surgery and often bowel resection, but mortality due to SIP seems lower. Studies looking at "long-term prognosis" of infants with NEC and bowel perforation have mainly assessed outcome until 2-7 years of age. The primary school years is a vulnerable period for ex-preterm children. Disruption in learning and social integration is of great importance for their quality of life (QoL), but little data exist in this age group. Moreover, nutritional deficits (e.g. cobalamin- or iron-deficiency may impact cognitive development, but this has not been investigated in this "high-risk" population in school age. Authors of a recent systematic review on gastrointestinal sequel after NEC-surgery thus called for "more high-quality studies assessing long-term follow-up". In this project we will study the long-term impact of surgery for NEC and bowel perforation in preterm infants, both with a quality of life (QoL) perspective and with a focus on development, growth, nutrition and persistent gastrointestinal problems.

Conditions

Necrotizing Enterocolitis; Intestinal Perforation; Premature Infant Disease

Keywords

necrotizing enterocolitis; bowel perforation; preterm infant; long-term follow-up; quality of life

Outcome Measures

Primary Outcomes (1)

• Pediatric quality of life (PedsQL) questionnaire

  modular approach measuring health-related QoL in children and adolescents (2-18 years) incl. children with acute and chronic health conditions. This questionnaire comprises of 4 essential core domains namely: Physical Functioning, Emotional Functioning, Social Functioning and School Functioning.

  2020-2021

Secondary Outcomes (6)

• Pediatric quality of life (QoL) Gastrointestinal Symptoms

  2025

• 5-15-R

  2025

• Blood samples

  2025

• Weight

  2025

• Height

  2025

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Cases and Controls will be identified through the Norwegian Neonatal Network.

You may qualify if:

• 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.).

You may not qualify if:

• not signing informed consent scheme

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital of North Norway

Tromsø, N-9038, Norway

Location

Related Publications (2)

• Hau EM, Meyer SC, Berger S, Goutaki M, Kordasz M, Kessler U. Gastrointestinal sequelae after surgery for necrotising enterocolitis: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F265-F273. doi: 10.1136/archdischild-2017-314435. Epub 2018 Jun 26.

  PMID: 29945925 BACKGROUND

• Neu J. Necrotizing enterocolitis: the mystery goes on. Neonatology. 2014;106(4):289-95. doi: 10.1159/000365130. Epub 2014 Aug 20.

  PMID: 25171544 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hemoglobin, MCV, Hb-reticulocyte count, total reticulocytes, ferritin, cobalamine, albumin, calcium, phosphorous, blood urea nitrogen and creatinine + essential micronutrient (fat- and watersoluble vitamins)

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Intestinal Perforation; Premature Birth

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Trond Flaegstad, MD, PhD

  University Hospital of North Norway

  STUDY DIRECTOR

Central Study Contacts

Claus Klingenberg, MD, PhD

CONTACT

91563167; claus.klingenberg@unn.no

Nina Hapnes, MD

CONTACT

47448119; nina.clare.hapnes@sus.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 3, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)