Long-term Nutritional Impact of Necrotizing Enterocolitis in Premature Newborns.

NCT07490834 | Enrolling By Invitation

• 1 other identifier: 2025PI067
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Necrotising Enterocolitis Neonatal; Nutrition Disorder, Child; Oral Disorders

Keywords

Necrotising Enterocolitis Neonatal

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Secondary Outcomes (1)

• Potential risk factors of NEC's complications

  5 years

Study Arms (1)

NEC Group

All Premature Neonates born in Nancy over 10 years and presenting NEC

Other: Observation of related perinatal and postnatal factors

Interventions

Observation of related perinatal and postnatal factors OTHER

Data described in Primary outcome measures will be collected in this group

NEC Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Premature newborns (\< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.

You may qualify if:

• Premature newborns (\< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria, in the NICU of Nancy between January 2014 and December 2023.

You may not qualify if:

• Children term born (\> 37 weeks of gestation)
• Necrotizing enterocolitis during an hospitalisation outside of the NICU of Nancy
• Malformation or pre-existing digestive pathology
• Complex or severe malformative pathologies
• Parents objecting with the collection of their child's data

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Maternité Régionale Universitaire de Nancy

Nancy, Lorraine, 54000, France

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Praticien Hospitalier

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: March 24, 2026
• Study Start: December 10, 2025
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

FR (1)