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 volunteersQualifiers
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
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
5-15-R
a standardized questionnaire for parents covering development and behavior of children and adolescents in ages 5 to 17 years
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
Weight
in kilogram and one decimal (e.g. 24.8 kg)
Sponsors and contacts
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