Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT00895869
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2009-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain in Neonates During Screening for Retinopathy of Prematurity Using Two Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012178', 'term': 'Retinopathy of Prematurity'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-20', 'studyFirstSubmitDate': '2009-05-07', 'studyFirstSubmitQcDate': '2009-05-07', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Screening', 'Retinopathy', 'Prematurity', 'Pain'], 'conditions': ['Retinopathy of Prematurity', 'Pain']}, 'descriptionModule': {'briefSummary': 'Retinopathy of prematurity screening is painful. Wide field digital retinal imaging (WFDRI) and binocular indirect ophthalmoscopy (BIO) are being used for screening examinations. The aim of Edinburgh, UK based study is to compare the pain experienced by infants using both examination techniques.', 'detailedDescription': "Infants undergoing routine eye screening at Edinburgh Royal Infirmary Neonatal Intensive Care Unit are to be recruited. Infants will be excluded if they require mechanical ventilation or analgesic medication or if they have moderate/severe neurological impairment. The first screening examination for each baby was included. Infants' eyes will be examined by both WFDRI and BIO with eyelid speculum by 2 experienced pediatric ophthalmologists in random order. Observations will be video-recorded during examinations to generate a pain score (premature infant pain profile) for both WFDRI and BIO. The pain scores, heart rates, oxygen saturations and time taken for WFDRI and BIO will be compared using paired t tests."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature infants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born at less than 32 weeks gestation and/or birth weight of less than 1500g.\n\nExclusion Criteria:\n\n* Infants requiring mechanical ventilation\n* Infants requiring analgesic medication\n* Infants with moderate/sever neurological impairment'}, 'identificationModule': {'nctId': 'NCT00895869', 'acronym': 'RETCAM', 'briefTitle': 'Pain in Neonates During Screening for Retinopathy of Prematurity Using Two Methods', 'organization': {'class': 'OTHER_GOV', 'fullName': 'NHS Lothian'}, 'officialTitle': 'Pain in Neonates During Screening for Retinopathy of Prematurity Using Binocular Indirect Ophthalmoscopy and Wide-field Digital Retinal Imaging: a Randomized Comparison', 'orgStudyIdInfo': {'id': 'BF01'}, 'secondaryIdInfos': [{'id': 'JB001'}, {'id': 'RF001'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'NHS Lothian', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Dr B Fleck, MBChB FRCOpth BSc(Hons) MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NHS Lothian'}, {'name': 'Dr C Dhaliwal, BSc(Hons) MBChB MRCPCH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Lothian'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Lothian', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}