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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07490834
Acronym
PremGrowth
Enrollment
200
Registered
2026-03-24
Start date
2025-12-10
Completion date
2026-06-01
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotising Enterocolitis Neonatal, Nutrition Disorder, Child, Oral Disorders

Keywords

Necrotising Enterocolitis Neonatal

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.

Interventions

OTHERObservation of related perinatal and postnatal factors

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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Complications and Nutritional impact of NEC within the first 5 years of life5 years* 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

Secondary

MeasureTime frameDescription
Potential risk factors of NEC's complications5 years\- 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026