Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 5:17 PM
Study NCT ID:
NCT04983069
Status:
UNKNOWN
Last Update Posted:
2021-11-15
First Post:
2021-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003085', 'term': 'Colic'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'C562687', 'term': 'Lysinuric Protein Intolerance'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postnatal outcome of fetuses', 'timeFrame': 'day 1 (End of follow up)', 'description': 'Postnatal outcome of fetuses with hyperechogenic colon.'}], 'secondaryOutcomes': [{'measure': 'Rate of lysinuria/cystinuria', 'timeFrame': 'day 1 (End of follow up)', 'description': 'Rate of lysinuria/cystinuria'}, {'measure': 'Rate of dibasic protein intolerance', 'timeFrame': 'day 1 (End of follow up)', 'description': 'Rate of dibasic protein intolerance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gynecology-Obstetrics', 'Ultrasound', 'Medical genetics', 'Pediatrics', 'Nephropathy', 'Colic hyperechogenicity', 'Antenatal', 'Lysinuria-cystinuria', 'lysinuric protein intolerance'], 'conditions': ['Colic', 'Nephropathy']}, 'descriptionModule': {'briefSummary': 'Fetal colic hyper-echogenicity is a presenting symptoms for cystinuria lysinuria.\n\nA few cases of fetuses with dibasic protein intolerance (more complex prognosis) presented with colic hyper-echogenicity antenatal.\n\nThe aim of this retrospective study is to assess the outcome of fetuses with colic hyperechogenicity in order to increase prenatal counseling', 'detailedDescription': 'Observational multicenter retrospective study from january 2011 to january 2021.\n\nNo supplementary visit, directly related to the research, will be necessary. This study does not change the usual management of the patient.\n\nPatients will be included after their usual medical check-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Foetuses with prenatal colic hyperechogenicity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Fetuses with prenatal colic hyperechogenicity\n* Between January 2011 and January 2021\n* Born without term limitation.\n\nExclusion criteria:\n\n* Intestinal hyperechogenicity\n* polymalformative syndrome\n* Patients Age\\<15 years'}, 'identificationModule': {'nctId': 'NCT04983069', 'acronym': 'COLONECHOGENE', 'briefTitle': 'Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity', 'orgStudyIdInfo': {'id': 'RECHMPL21_0376'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florent Fuchs, PhD', 'role': 'CONTACT', 'email': 'f-fuchs@chu-montpellier.fr'}, {'name': 'Alexis RODRIGUEZ', 'role': 'CONTACT', 'email': 'alexis-rodriguez@chu-montpellier.fr', 'phone': '668591043', 'phoneExt': '33'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Florent FUCHS, PhD', 'role': 'CONTACT', 'email': 'f-fuchs@chu-montpellier.fr', 'phone': '04 67 33 09 80', 'phoneExt': '33'}, {'name': 'Alexis RODRIGUEZ, resident', 'role': 'CONTACT', 'email': 'alexis-rodriguez@chu-montpellier.fr', 'phone': '668591043', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Florent FUCHS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}