Necrotising Enterocolitis NeonatalPremGrowthNCT07490834
Long-term Nutritional Impact of Necrotizing Enterocolitis in Premature Newborns.
An observational study of Necrotising Enterocolitis Neonatal and Nutrition Disorder, Child, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Necrotising Enterocolitis Neonatal, Nutrition Disorder, Child, Oral Disorders
- What is being tested?
- Observation of related perinatal and postnatal factors
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2025to Jun 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Premature newborns (< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Being tested
- Observation of related perinatal and postnatal factors
- Keywords
- Necrotising Enterocolitis Neonatal
- Medical subject headings
- Enterocolitis, Necrotizing, Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of related perinatal and postnatal factorsOther
Data described in Primary outcome measures will be collected in this group
| Study group | Role | What they receive |
|---|---|---|
| NEC Group | All Premature Neonates born in Nancy over 10 years and presenting NEC Receives: Other: Observation of related perinatal and postnatal factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start10 Dec 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotising Enterocolitis NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LAMIREAU Nathalie, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490834
- Sponsor's protocol ID
- 2025PI067
- Acronym
- PremGrowth
- Status last verified
- Mar 2026
- First submitted
- 22 Jul 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No