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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-15
SponsorUniversity Hospital of North Norway

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.).

Disqualifiers

not signing informed consent scheme

Trial population

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

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
2020-2021

Secondary outcomes

1

Pediatric quality of life (QoL) Gastrointestinal Symptoms

Validated questionnaire assessing gastrointestinal problems.The questionnaire reports data on gastrointestinal symptoms, within 10 scales. The final score goes from 0-100 and higher values indicates less symptoms and better QoL.

Time frame
2025
2

5-15-R

a standardized questionnaire for parents covering development and behavior of children and adolescents in ages 5 to 17 years

Time frame
2025
3

Blood samples

Hb, leukocytes with differential count, platelets, reticulocytes, mean corpuscular volume, Hb in reticulocytes, ferritin, 25-OH vitamin D, cobalamine, urea, creatinine, calcium, phosphorous, 9 essential trace elements, a broad panel of other fat and water soluble vitamins. Data will be reported in SI units, or other conventional measures. For this outcome we will report data on number of participants with 1, 2, 3 or 4 or more abnormal laboratory values

Time frame
2025
4

Weight

in kilogram and one decimal (e.g. 24.8 kg)

Time frame
2025

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: