Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 10:12 AM
Study NCT ID:
NCT04519060
Status:
UNKNOWN
Last Update Posted:
2021-03-12
First Post:
2020-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye Shields for Infants After Dilated Exam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D012178', 'term': 'Retinopathy of Prematurity'}, {'id': 'D005128', 'term': 'Eye Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2020-05-17', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of stress events', 'timeFrame': '4-6 hours (from first dose of eye dilating medication to four hours after last dose)', 'description': 'The primary outcome will be measured by the count of apneas and bradycardias (stress events) experienced by the infant during the period of eye dilation without eye shields as compared to the total stress events experienced when dilated eyes are covered with eye shields.'}], 'secondaryOutcomes': [{'measure': 'Number of stress events amongst covariates', 'timeFrame': '4-6 hours (from first dose of eye dilating medication to four hours after last dose)', 'description': 'The secondary outcome measure will be abstracted from covariate data (e.g., infant gestational age at birth, post-natal age, weight, and ventilation status) to assess the influence of covariables on the response to eye shields as an intervention to lessen stress and discomfort in hospitalized infants after dilated eye exam.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eye shield', 'eye protector', 'eye patch', 'eye mask', 'phototherapy'], 'conditions': ['Infant, Newborn, Disease', 'Pain', 'Retinopathy of Prematurity', 'Eye Diseases']}, 'descriptionModule': {'briefSummary': 'The eyes of hospitalized infants are often assessed by dilated exam, and there is evidence that infants experience post-exam stress. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.', 'detailedDescription': "Neonatal eye examinations are the standard of best practice in pediatrics. In the acute clinical setting, infants' eyes are inspected for eye development, defect, and disease. There is anecdotal and clinical evidence that infants experience stress after eye dilation. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronological age 0-12 months\n* Infants who require dilated eye exams\n* Parent or legal guardian consent/permission granted\n\nExclusion Criteria:\n\n* More than a two-week interval between dilated eye exams\n* Prior or ongoing medical treatment or therapy for the eye(s)\n* Functional blindness diagnosed by eye exam'}, 'identificationModule': {'nctId': 'NCT04519060', 'briefTitle': 'Eye Shields for Infants After Dilated Exam', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam', 'orgStudyIdInfo': {'id': 'CHLA-20-00211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No eye shields after dilated eye exam', 'description': 'Eye dilation for scheduled exam will be followed by routine clinical care.'}, {'type': 'EXPERIMENTAL', 'label': 'Eye shields after dilated eye exam', 'description': 'Eye dilation for scheduled exam will be followed by routine clinical care and the application of eye shields. They will be worn until four (4) hours after the last dose of dilating eye drops.', 'interventionNames': ['Device: phototherapy eye shield']}], 'interventions': [{'name': 'phototherapy eye shield', 'type': 'DEVICE', 'otherNames': ['phototherapy eye protector', 'phototherapy eye mask'], 'description': 'Phototherapy eye shields will be applied to the eyes of infants dilated for scheduled eye exam. They will be worn until four (4) hours after the last dose of dilating eye drops.', 'armGroupLabels': ['Eye shields after dilated eye exam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maxine Ogbaa, BSN', 'role': 'CONTACT', 'email': 'mogbaa@chla.usc.edu', 'phone': '323-361-2531'}, {'name': 'Heidi Machen, PHN, BSN', 'role': 'CONTACT', 'email': 'hmachen@chla.usc.edu', 'phone': '323-361-2531'}, {'name': 'Maxine Ogbaa, BSN', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Heidi Machen, PHN, BSN', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Maxine Ogbaa, BSN', 'role': 'CONTACT', 'email': 'mogbaa@chla.usc.edu', 'phone': '323-361-2531'}, {'name': 'Heidi Machen, PHN, BSN', 'role': 'CONTACT', 'email': 'hmachen@chla.usc.edu', 'phone': '323-361-2531'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BSN', 'investigatorFullName': 'Maxine Ogbaa', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}