An observational study in Necrotising Enterocolitis Neonatal, Nutrition Disorder, Child and Oral Disorders, sponsored by Central Hospital, Nancy, France. Enrolling by invitation at 1 site in France. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Central Hospital, Nancy, France · Observational
With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased. NEC affects between 2 to 7% of premature infants including 5 to 22% of newborns weighing less than 1000 g.
NEC is an acquired disease, caused by inflammation of the intestinal lining. It is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
The etiologies and pathophysiology of this disease are multifactorial and complex, and remain poorly understood. The imputability of associated factors is difficult to establish. The mechanism of the lesions observed seems to involve many factors, including immaturity of the intestinal barrier and immune system, microvascular imbalance, disturbed intestinal flora and systemic inflammation.
Survivors frequently have long-term sequelae that depend on the severity of ECUN and its treatment. Up to 20% of patients develop secondary intestinal stenosis requiring surgical intervention. In addition, around 25% of patients treated for ECUN develop short small bowel syndrome. Studies also showed that patients with ECUN were at greater risk of developing growth retardation and neurodevelopmental delay.
Early and regular medical follow-up could reduce the risk of mortality and morbidity. It therefore seems essential to be able to predict the risk of long-term complications of enterocolitis in our department, in order to detect and manage them as early as possible.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 200 is above the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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Premature newborns (\< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.
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Exclusion Criteria:
All Premature Neonates born in Nancy over 10 years and presenting NEC
Other: Observation of related perinatal and postnatal factors
Data described in Primary outcome measures will be collected in this group
Complications and Nutritional impact of NEC within the first 5 years of life
* Atopy : cow's milk protein allergy, food allergies, eczema/dermatitis, asthma, allergic rhinitis * Orality disorder : need for specialized follow-up * Statural growth retardation (Height\<-2DS) * Weight growth retardation (Weight\<-2DS) * gastroesophageal reflux disease : need for anti-reflux therapy * Esophagitis : pH metry diagnosis * Transit disorders : Laxatives or anti-diarrhea therapy required * Undernutrition : moderate BMI \< 18.5 or severe BMI \< 17 * Repeat surgery : any stay in the operating room
Time frame: 5 years
Potential risk factors of NEC's complications
\- Atopy : cow's milk protein allergy, food allergies, eczema/dermatitis, asthma, allergic rhinitis - Orality disorder : need for specialized follow-up - Statural growth retardation (Height\<-2DS) - Weight growth retardation (Weight\<-2DS) - gastroesophageal reflux disease : need for anti-reflux therapy - Esophagitis : pH metry diagnosis - Transit disorders : Laxatives or anti-diarrhea therapy required - Undernutrition : moderate BMI \< 18.5 or severe BMI \< 17 - Repeat surgery : any stay in the operating room
Time frame: 5 years
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Central Hospital, Nancy, France →