Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-26 @ 5:35 AM
Study NCT ID:
NCT01552993
Status:
TERMINATED
Last Update Posted:
2016-04-22
First Post:
2012-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registration and Treatment of Pain During Eye Examination of Prematurity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D010146', 'term': 'Pain'}], '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': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D013395', 'term': 'Sucrose'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'the chosen intervention was obviously ineffective', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-21', 'studyFirstSubmitDate': '2012-03-02', 'studyFirstSubmitQcDate': '2012-03-09', 'lastUpdatePostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '5 minutes', 'description': 'Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prematurity', 'retinopathy', 'pain', 'acetaminophen'], 'conditions': ['Infant, Premature', 'Retinopathy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.', 'detailedDescription': 'Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented.\n\nThis is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '31 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants \\< 32 weeks of gestational age (\\< 31+6 weeks)\n\nExclusion Criteria:\n\n* Infants with ongoing analgesic treatment'}, 'identificationModule': {'nctId': 'NCT01552993', 'briefTitle': 'Registration and Treatment of Pain During Eye Examination of Prematurity', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Registration and Treatment of Pain During Eye Examination of Prematurity', 'orgStudyIdInfo': {'id': 'HB2012-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'paracetamol', 'description': 'Paracetamol mixture 20 mg/kg + pacifier and sucrose', 'interventionNames': ['Drug: paracetamol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'pacifier and sucrose only', 'interventionNames': ['Drug: sucrose']}], 'interventions': [{'name': 'paracetamol', 'type': 'DRUG', 'description': 'Paracetamol mixture 20 mg/kg + pacifier and glucose', 'armGroupLabels': ['paracetamol']}, {'name': 'sucrose', 'type': 'DRUG', 'description': 'pacifier and sucrose', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'state': 'Trøndelag', 'country': 'Norway', 'facility': 'St.Olavs University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Hakon Bergseng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}