Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-04-26 @ 4:15 AM
Study NCT ID:
NCT02872350
Status:
UNKNOWN
Last Update Posted:
2016-08-19
First Post:
2016-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 95}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-16', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2016-08-16', 'lastUpdatePostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comment prognostic evaluation by abdominal ultrasound', 'timeFrame': '36 months', 'description': 'Assessment in clinical outcome prognosis by abdominal ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['the Necrotizing Enterocolitis', 'Preterm Infants']}, 'descriptionModule': {'briefSummary': 'Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants.\n\nThe diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the diagnosis. The prognostic value of these radiographic findings is currently controversial.\n\nAbdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to be considered for some years. It also has other advantages, including that of not being a radiating examination. Studies on the prognostic value of abdominal ultrasound are rather few. Moreover, they involve a series of heterogeneous patients in terms of gestational age. Or the pathophysiology of ECUN in children born at term and in children born prematurely is not the same.\n\nThe objective is to study prospectively the prognostic contribution of abdominal ultrasound in the ECUN in premature under 33SA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '33 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth Term strictly less than 33SA\n* Gestational age some (assessed on early ultrasound dating)\n* Congenital malformation of Absence\n* Suggestive clinical symptomatology of ECUN defined by the presence of abdominal bloating, increased residues (\\> 20% of the volume of enteral feeding) and the presence of blood in stool (macro- or microscopic)\n* Radiologic investigation with a radiograph of abdomen and abdominal ultrasound done for the episode of ECUN\n* Maximum interval between imaging tests 2 hours\n* No parental opposition to the participation of children in the study\n\nExclusion Criteria:\n\n* Term higher or equal to 33 weeks\n* Congenital malformation\n* Parental Opposition (or legal representatives) to participate in the study'}, 'identificationModule': {'nctId': 'NCT02872350', 'acronym': 'ECUN', 'briefTitle': 'Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'orgStudyIdInfo': {'id': '2015-34'}, 'secondaryIdInfos': [{'id': '2015-A01628-41', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Premature with necrotizing enterocolitis', 'interventionNames': ['Device: Abdominal ultrasound']}], 'interventions': [{'name': 'Abdominal ultrasound', 'type': 'DEVICE', 'description': 'Techniques and predictive characteristics of the combination abdominal ultrasound abdomen and shot in the prognostic assessment of ECUN in premature under 33SA.', 'armGroupLabels': ['Premature with necrotizing enterocolitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Aurelie GARBI, PH', 'role': 'CONTACT', 'email': 'aurelie.garbi@ap-hm.fr', 'phone': '0491968300'}, {'name': 'Urielle DESALBRES, Director', 'role': 'CONTACT', 'email': 'drci@ap-hm.fr', 'phone': '0491382747'}, {'name': 'Aurelie GARBI, PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Aurelie GARBI, PH', 'role': 'CONTACT', 'email': 'aurelie.garbi@ap-hm.fr', 'phone': '0491968300'}, {'name': 'Urielle DESALBRES, Director', 'role': 'CONTACT', 'email': 'drci@ap-hm.fr', 'phone': '01491382747'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}