Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-28 @ 2:33 PM
Study NCT ID:
NCT01835392
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2013-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2013-04-16', 'studyFirstSubmitQcDate': '2013-04-16', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurodevelopment', 'timeFrame': '12 months of age', 'description': 'Neurodevelopmental outcomes at 12 (+/- 1) months of age as measured by the Bayley Scales of Infant and Toddler Development, Third Edition and the Infant Development Inventory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Remote ischemic preconditioning', 'Heart defects, congenital', 'cardiac surgery', 'Neurodevelopmental outcomes'], 'conditions': ['Heart Defects, Congenital']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to look at whether the use of a simple technique before surgery, which involves inflating a blood pressure cuff on the infant's leg, can improve development of language, motor and thinking skills at 12 months of age. Some research has found that a brief shortage of blood supply to an organ (such as a leg) at level that does not cause harm may help the body to tolerate a longer and more severe shortage of blood (for example, during surgery).", 'detailedDescription': "The purpose of this study is to look at whether the use of a simple technique before surgery, which involves inflating a blood pressure cuff on the infant's leg, can improve development of language, motor and thinking skills at 12 months of age. Some research has found that a brief shortage of blood supply to an organ (such as a leg) at level that does not cause harm may help the body to tolerate a longer and more severe shortage of blood (for example, during surgery).\n\nNeurodevelopmental Assessment:\n\nThe Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)9 assesses the developmental functioning of infants and young children between the ages of 1 month and 42 months. Cognitive, language, and motor development are assessed through structured play activities. Social-emotional and adaptive functioning are assessed through parent questionnaires. Administration time is 45 - 60 minutes, depending on the child's performance and behavior. Psychometric properties are well defined and acceptable. Composite scores for cognitive, language, motor, social-emotional, and adaptive behavior are standardized with a mean of 100 and a standard deviation of 15.\n\nThe Infant Development Inventory (IDI)10 will also be used to assess neurodevelopmental functioning, based on parent report. Parents are asked to rate their child's developmental skills in five domains: social, self help, gross motor, fine motor and language. Administration time is approximately 10 minutes. Infants are categorized as delayed or not delayed for each of the five domains."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants \\<7 months of age\n* Undergoing open heart surgery\n* Written informed consent\n\nExclusion Criteria:\n\n* Presence of known gross neurologic abnormality preoperatively\n* History of birth asphyxia\n* Non-English speaking family'}, 'identificationModule': {'nctId': 'NCT01835392', 'briefTitle': 'Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery', 'orgStudyIdInfo': {'id': '259980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote Ischemic Preconditioning', 'description': 'Four 5-minute cycles of leg ischemia interspersed with 5-minute cycles of reperfusion using a blood pressure cuff inflated to a pressure 15 mmHg greater than the systolic arterial pressure.', 'interventionNames': ['Procedure: Remote Ischemic Preconditioning']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Placement of blood pressure cuff around leg without inflation for 40 minutes', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Remote Ischemic Preconditioning', 'type': 'PROCEDURE', 'otherNames': ['RIPC', 'Remote Ischemic Conditioning'], 'description': 'Lower limb ischemia/reperfusion cycles', 'armGroupLabels': ['Remote Ischemic Preconditioning']}, {'name': 'Control', 'type': 'OTHER', 'otherNames': ['Sham'], 'description': 'Sham placement of blood pressure cuff without inflation', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nemours Cardiac Center', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}], 'overallOfficials': [{'name': 'Christian Pizarro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nemours'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}