Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT02890251
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2016-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Maturation in Premature Newborns According to Factors Influencing Its Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Visual Acuity by Baby Vision Cards', 'timeFrame': 'Baseline', 'description': 'Baby Vision cards are the French equivalent of Teller Cards - The measurement will be done at the term equivalent age : at the inclusion'}], 'secondaryOutcomes': [{'measure': 'Control of the Retina by Retinal Camera', 'timeFrame': 'Baseline', 'description': 'Use of Retcam to diagnose Retinopathy of Prematurity - The measurement will be done at the term equivalent age : at the inclusion'}, {'measure': 'Measurement of cycloplegic refraction by mydriaticum 0.5%', 'timeFrame': 'Baseline', 'description': 'The measurement will be done at the term equivalent age : at the inclusion'}, {'measure': 'Presence, absence of light reflex by clinical evaluation', 'timeFrame': 'Baseline', 'description': 'The measurement will be done at the term equivalent age : at the inclusion'}, {'measure': 'Presence, absence or abnormality of visual fixation by clinical observation', 'timeFrame': 'Baseline', 'description': 'The measurement will be done at the term equivalent age : at the inclusion'}, {'measure': 'Analysis of visual cortex with MRI', 'timeFrame': 'Baseline', 'description': 'Determinants of indices of cerebral volume in former very premature infants and their relation to visual maturation. The measurement will be done at the term equivalent age : at the inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infant', 'Premature', 'Diseases'], 'conditions': ['Delayed Visual Maturation']}, 'referencesModule': {'references': [{'pmid': '30515105', 'type': 'BACKGROUND', 'citation': 'Wirth M, Naud A, Schmitt E, Clerc-Urmes I, Hascoet JM. Visual Maturation at Term Equivalent Age in Very Premature Infants According to Factors Influencing Its Development. Front Physiol. 2018 Nov 20;9:1649. doi: 10.3389/fphys.2018.01649. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose is to describe the level of visual maturation of premature newborns at term equivalent age.\n\nThe secondary purpose is to determine factors associated to an altered level of visual maturation, through an exploratory approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Weeks', 'minimumAge': '6 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature babies, born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy, evaluated at term equivalent age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy\n\nExclusion Criteria:\n\n* Parental opposition\n* Ocular malformation\n* Face malformation\n* Cranial stenosis\n* Chromosomal abnormality'}, 'identificationModule': {'nctId': 'NCT02890251', 'acronym': 'PREMAVISION', 'briefTitle': 'Visual Maturation in Premature Newborns According to Factors Influencing Its Development', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Visual Maturation in Premature Newborns According to Factors Influencing Its Development', 'orgStudyIdInfo': {'id': 'PSS2016/PREMAVISION-HASCOET/VS'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jean-Michel HASCOET, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maternité Régionale Universitaire A. Pinard CHRU Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jean-Michel HASCOET', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}