Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02088359
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2014-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare of Effectiveness Cycled Light or Near Darkness on Growth Parameters in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2014-03-07', 'studyFirstSubmitQcDate': '2014-03-12', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness on growth', 'timeFrame': '3-12 months', 'description': "We recorded infants' weight, height and head circumference measures on day 14, corrected 3 and 6 months."}], 'secondaryOutcomes': [{'measure': 'Feeding', 'timeFrame': '0-1 month', 'description': 'We evaluated full enteral feeding time between two groups.'}, {'measure': 'Ventilation support', 'timeFrame': '0-1 month', 'description': 'We evaluated duration of supplemental oxygen, nasal continuous positive airway pressure (CPAP) and mechanical ventilation for each groups.'}]}, 'conditionsModule': {'keywords': ['cycled light, near darkness, growth'], 'conditions': ['Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm Infants']}, 'referencesModule': {'references': [{'pmid': '39699174', 'type': 'DERIVED', 'citation': 'Morag I, Xiao YT, Bruschettini M. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD006982. doi: 10.1002/14651858.CD006982.pub5.'}]}, 'descriptionModule': {'briefSummary': 'Infants are exposed to either continuous bright light continuous near darkness or unstructured combination of the two. The investigators primary objective is to determine the effectiveness cycled light and near darkness on growth in preterm infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infant (\\<32 gestational weeks) were enrolled in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<32 gestational weeks preterm infants\n\nExclusion Criteria:\n\n* Major congenital anomaly\n* Small for gestation age\n* Grade III-IV intracranial hemorrhage'}, 'identificationModule': {'nctId': 'NCT02088359', 'briefTitle': 'Compare of Effectiveness Cycled Light or Near Darkness on Growth Parameters in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'orgStudyIdInfo': {'id': 'ZTB000123'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cycled light', 'description': 'Approximately 12 hours of light on and 12 hours of light off.', 'interventionNames': ['Other: Cycled light']}, {'label': 'Near darkness', 'description': 'Continue near darkness', 'interventionNames': ['Other: Continue near darkness']}], 'interventions': [{'name': 'Cycled light', 'type': 'OTHER', 'description': 'We covered the incubator with blanket for darkness approximately 12 hours.', 'armGroupLabels': ['Cycled light']}, {'name': 'Continue near darkness', 'type': 'OTHER', 'description': 'We covered the incubator with blanket all days.', 'armGroupLabels': ['Near darkness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Zekai Tahir Burak Maternity Teaching Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Zekai Tahir Burak Maternity and Teaching Hospital', 'investigatorFullName': 'Mehmet Yekta', 'investigatorAffiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}}}}