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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07490834
- Acronym / sponsor ID
- PremGrowth / 2025PI067
- Keywords
- Necrotising Enterocolitis Neonatal
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEC Group | – | Other: Observation of related perinatal and postnatal factorsAll Premature Neonates born in Nancy over 10 years and presenting NEC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of related perinatal and postnatal factorsData described in Primary outcome measures will be collected in this group | Other | NEC Group |
Primary outcome
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
1 secondary outcome
Potential risk factors of NEC's complications
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Related trials for Necrotising Enterocolitis Neonatal
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotising Enterocolitis Neonatal and Nutrition Disorder, Child, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications and Nutritional impact of NEC within the first 5 years of life (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.