Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT02505360
Status:
UNKNOWN
Last Update Posted:
2015-07-22
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biochemical and Histological Comparison of Nasal and Auricular Cartilage in the Fetus and Newborn With Cleft Lip Carrier
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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-21', 'studyFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2015-07-21', 'lastUpdatePostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Newborn Cleft Lip and Slot Carrier']}, 'descriptionModule': {'briefSummary': 'We seek to compare biochemically and histologically the nasal cartilage and ear in the newborn cleft lip and slot carrier in order to improve the quality of care and patient comfort after surgery of cheilorhinoplasty which is the primary treatment slots .\n\nThe concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by immunohistochemistry and study of mRNA and then they are compared according to the type of cartilage.\n\nThis comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip and operated in the neonatal period.\n\nGiven the difficulty and constraint of time it takes to reach the 20 subjects of our study , we will also add to our population the stillborn babies before 25SA and newborns who die before the age of 28 days and having had an autopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants aged 0 to 5 weeks with an isolated cleft lip and palate, that is to say non-syndromic, and that will be operated for cheilorhinoplasty neonatal, whose parents have read and understood the document Information and accepted and signed informed consent,\n* Children born without life before 25SA and whose parents have read and understood the Information and accepted and signed informed consent for diagnostic purposes permission to autopsy and scientific purposes and / or therapeutic.\n* Newborns who died before 28 days of life and whose parents have read and understood the Information and accepted and signed informed consent for diagnostic purposes permission to autopsy and scientific purposes and / or therapeutic.\n* Patients And relatives of patients who received clear information and having signed an informed consent,\n* Patients Benefiting from a health insurance plan\n\nExclusion Criteria:\n\n* Patient with no lip slots ( bike palate only or other Tessier slot ) )\n* Patient having slots syndromic cleft lip\n* Patient whose parents refuse entry into the study.\n* Children born without life before 25SA\n* Newborns who died after 28 days of life'}, 'identificationModule': {'nctId': 'NCT02505360', 'acronym': 'CARTOON', 'briefTitle': 'Biochemical and Histological Comparison of Nasal and Auricular Cartilage in the Fetus and Newborn With Cleft Lip Carrier', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Comparaison Biochimique et Histologique Des Cartilages Nasal et Auriculaire Chez le fœtus et le Nouveau-né Porteur de Fente Labiale', 'orgStudyIdInfo': {'id': '14-052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'nasal and ear cartilage taken from the newborn', 'description': 'to compare biochemical and histological characteristics of both nasal and ear cartilage taken from the newborn at the time of surgical time cheilorhinoplasty', 'interventionNames': ['Other: Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3']}], 'interventions': [{'name': 'Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3', 'type': 'OTHER', 'armGroupLabels': ['nasal and ear cartilage taken from the newborn']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexis VESSYERE, MD', 'role': 'CONTACT', 'email': 'veyssiere-a@chu-caen.fr', 'phone': '02.31.06.48.15'}], 'facility': 'Service de Chirurgie Maxillo-Faciale', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}