Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:21 AM
Study NCT ID:
NCT07490834
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-24
First Post:
2025-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Nutritional Impact of Necrotizing Enterocolitis in Premature Newborns.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}, {'id': 'D015362', 'term': 'Child Nutrition Disorders'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-22', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2026-03-22', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications and Nutritional impact of NEC within the first 5 years of life', 'timeFrame': '5 years', 'description': "* Atopy : cow's milk protein allergy, food allergies, eczema/dermatitis, asthma, allergic rhinitis\n* Orality disorder : need for specialized follow-up\n* Statural growth retardation (Height\\<-2DS)\n* Weight growth retardation (Weight\\<-2DS)\n* gastroesophageal reflux disease : need for anti-reflux therapy\n* Esophagitis : pH metry diagnosis\n* Transit disorders : Laxatives or anti-diarrhea therapy required\n* Undernutrition : moderate BMI \\< 18.5 or severe BMI \\< 17\n* Repeat surgery : any stay in the operating room"}], 'secondaryOutcomes': [{'measure': "Potential risk factors of NEC's complications", 'timeFrame': '5 years', 'description': "\\- 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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Necrotising Enterocolitis Neonatal'], 'conditions': ['Necrotising Enterocolitis Neonatal', 'Nutrition Disorder, Child', 'Oral Disorders']}, 'descriptionModule': {'briefSummary': '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.\n\nNEC 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.\n\nThe 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.\n\nSurvivors 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.\n\nEarly 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Premature newborns (\\< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Children term born (\\> 37 weeks of gestation)\n* Necrotizing enterocolitis during an hospitalisation outside of the NICU of Nancy\n* Malformation or pre-existing digestive pathology\n* Complex or severe malformative pathologies\n* Parents objecting with the collection of their child's data"}, 'identificationModule': {'nctId': 'NCT07490834', 'acronym': 'PremGrowth', 'briefTitle': 'Long-term Nutritional Impact of Necrotizing Enterocolitis in Premature Newborns.', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Evaluate the Long-term Nutritional Impact of Necrotizing Enterocolitis at 5 Years, in Premature Newborns in the NICU of NANCY Over 10 Years.', 'orgStudyIdInfo': {'id': '2025PI067'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NEC Group', 'description': 'All Premature Neonates born in Nancy over 10 years and presenting NEC', 'interventionNames': ['Other: Observation of related perinatal and postnatal factors']}], 'interventions': [{'name': 'Observation of related perinatal and postnatal factors', 'type': 'OTHER', 'description': 'Data described in Primary outcome measures will be collected in this group', 'armGroupLabels': ['NEC Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'state': 'Lorraine', 'country': 'France', 'facility': 'Maternité Régionale Universitaire de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Praticien Hospitalier', 'investigatorFullName': 'LAMIREAU Nathalie', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}