Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07490834

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observation of related perinatal and postnatal factors

Other

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

Primary outcomes

  1. Complications and Nutritional impact of NEC within the first 5 years of life

    Time frame: 5 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 outcomes

  1. Potential risk factors of NEC's complications

    Time frame: 5 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: PremGrowth

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.