Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT03155360
Status:
UNKNOWN
Last Update Posted:
2017-08-09
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infants Colics : Towards a Migrainous Origin ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003085', 'term': 'Colic'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of real colics according to Wessel definition', 'timeFrame': 'At the inclusion'}, {'measure': 'Proportion of migrainous parents', 'timeFrame': 'At the inclusion', 'description': 'Proportion of migrainous parents in each group'}], 'secondaryOutcomes': [{'measure': 'Proportion of Infant colics according the feeling parents', 'timeFrame': 'At the inclusion'}, {'measure': 'Proportion of maternal migraine', 'timeFrame': 'At the inclusion'}, {'measure': 'Proportion of partenal migraine', 'timeFrame': 'At the inclusion'}, {'measure': 'Age of begining of colics', 'timeFrame': 'At the inclusion', 'description': 'average and median age'}, {'measure': 'Age of ending of colics', 'timeFrame': 'At the inclusion', 'description': 'average and median age'}, {'measure': 'Proportion of real colics according to Wessel definition in the subgroup of parents who report that their child has colic', 'timeFrame': 'at the inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colics', 'infant colics', 'Migraine equivalent', 'Migraine', 'Episodic symptoms associated to migraine', 'Colic'], 'conditions': ['Colic, Infantile', 'Migraine', 'Migraine Equivalents']}, 'descriptionModule': {'briefSummary': "According to recent studies, we want to find evidences that infant colics could be a episodic symptom associated to migraine as cyclic vomiting syndrome or abdominal migraine are. The main purpose is to compare the presence of colics in infants between 60 days and 180 days of life and the presence of migraine in their parents to determine if colicky children's parents are more migrainous than other parents.", 'detailedDescription': "Recent studies shows that :\n\n* Infants with colics have more probability to become migrainous when they will grow up\n* Migrainous children have more colic history in their past\n* Migrainous parents have more babies with colics than non-migrainous parents\n\nAccording to these studies, we want to find othen evidences that infant colics could be a migraine equivalent as cyclic vomiting syndrome or abdominal migraine are. Recently, the international classification of headache disease IIIbeta added in its appendix colics in the episodic symptoms associated to migraine\n\nThe main purpose of our study in the pediatric emergency unit of Nancy is to compare the presence of colics in infants and the presence of migraine in their parents to determine if colicky children's parents are more migrainous than other parents. The data collection will be made thanks to a survey which will be completed by the parents."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '180 Days', 'minimumAge': '60 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All infants between 60 days and 180 days of life who comes to the Nancy University Hospital pediatric emergency unit', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All infants between 60 days and 180 days of life who comes to the Nancy University Hospital pediatric emergency unit\n\nExclusion Criteria:\n\n* Language barrier of parents'}, 'identificationModule': {'nctId': 'NCT03155360', 'acronym': 'COLIGRAINE', 'briefTitle': 'Infants Colics : Towards a Migrainous Origin ?', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Association Between Infant Colics and Parental Migraine ? Non Interventional Study in the Pediatric Emergency Unit of Nancy (France) University Hospital', 'orgStudyIdInfo': {'id': '2017-A00185-48'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infant with colics', 'description': 'Infants with colics according to Wessel definition :\n\n* Recurrent episodes of irritability, fussing or crying from birth to 4 months of age\n* Episodes last for 3 hours per day ; on 3 days per week ; for 3 weeks\n* Episodes can not be attributed to another disorder', 'interventionNames': ['Other: Non interventional study']}, {'label': 'Infant without colics', 'interventionNames': ['Other: Non interventional study']}], 'interventions': [{'name': 'Non interventional study', 'type': 'OTHER', 'description': 'Non interventional study', 'armGroupLabels': ['Infant with colics', 'Infant without colics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François BREZIN', 'role': 'CONTACT'}], 'facility': 'Dr BORSA-DORION Anne', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'François BREZIN', 'role': 'CONTACT', 'email': 'francois.brezin@gmail.com', 'phone': '00 33 6 63 78 08 87'}, {'name': 'Anne BORSA-DORION', 'role': 'CONTACT', 'email': 'a.borsa-dorion@chru-nancy.fr', 'phone': '00 33 3 83 15 47 33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}