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

Evaluate the Long-term Nutritional Impact of Necrotizing Enterocolitis at 5 Years, in Premature Newborns in the NICU of NANCY Over 10 Years.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nutrition Disorder, Child; Necrotising Enterocolitis Neonatal; Oral Disorders
• Intervention / Treatment: Other: Observation of related perinatal and postnatal factors

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54000
      • Maternité Régionale Universitaire de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NEC Group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 22, 2025
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Necrotising Enterocolitis Neonatal
• Additional Relevant MeSH Terms: Nutrition Disorders; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Enterocolitis; Nutritional and Metabolic Diseases; Child Nutrition Disorders; Enterocolitis, Necrotizing
• Other Study ID Numbers: 2025PI067

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No