Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-28 @ 1:12 AM
Study NCT ID:
NCT03104751
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2017-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurodevelopment in Infants With Complex Congenital Heart Defects
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': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2017-03-27', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Salivary cortisol', 'timeFrame': '0-30 days, 3 months, 6 months', 'description': 'Saliva sample to measure snapshot of cortisol release'}, {'measure': 'Hair cortisol', 'timeFrame': '0-30 days, 3 months, 6 months', 'description': 'Hair cortisol provides a validated measure of intensity and course of stress exposure over time and is considered a proxy measure of total HPA activation'}, {'measure': 'Fingernail cortisol', 'timeFrame': '0-30 days, 3 months, 6 months', 'description': 'Fingernail sample to measure cortisol levels'}], 'primaryOutcomes': [{'measure': 'Change in MRI (Magnetic Resonance Imaging) of brain - infants with CCHD only', 'timeFrame': '1 to 5 days days prior to surgery, 4-10 days after surgery, 6 months of age', 'description': 'Brain MRI'}, {'measure': 'Change in Test of Infant Motor Performance (TIMP)', 'timeFrame': '0-30 days, 3 months', 'description': 'test of early motor development'}, {'measure': 'Change in Mobile Paradigm', 'timeFrame': '3 months and 6 months', 'description': 'Measure of learning, memory, and task-specific kicking coordination in infants'}, {'measure': 'Change in Heart Rate Variability', 'timeFrame': '30 days, 3 months, 6 months', 'description': 'Measure of autonomic nervous system function and development'}], 'secondaryOutcomes': [{'measure': 'Bayley Scales of Motor Development', 'timeFrame': '3 months, 6 months', 'description': 'The Bayley Scales of Infant and Toddler Development is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior.'}, {'measure': 'Edinburgh Postnatal Depression Scale', 'timeFrame': '0-30 days, 3 months, 6 months', 'description': 'self report survey to assess maternal depression'}, {'measure': 'Infant-Toddler Quality of Life Questionnaire', 'timeFrame': '0-30 days, 3 months, 6 months', 'description': 'self report survey to assess infant health status and physical and psychosocial functioning'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': '0-30 days, 3 months, 6 months', 'description': 'sefl report survey measure of anxiety'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complex Congenital Heart Defect', 'Infants'], 'conditions': ['Complex Congenital Heart Defect']}, 'referencesModule': {'references': [{'pmid': '35190880', 'type': 'DERIVED', 'citation': 'Tripathi T, Harrison TM, Simsic JM, Cabral TI, Heathcock JC. Screening and Evaluation of Neurodevelopmental Impairments in Infants Under 6 Months of Age with Congenital Heart Disease. Pediatr Cardiol. 2022 Mar;43(3):489-496. doi: 10.1007/s00246-021-02745-4. Epub 2022 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with Complex Congenital Heart Disease (CCHD).', 'detailedDescription': "The investigators' long-term goals are to develop a method of identifying infants likely to have adverse neurodevelopmental outcomes following neonatal treatment for CCHD and to develop and test interventions that can be applied early in infancy. The necessary first step is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with CCHD. Each measure provides unique information about development and will include (1) neuroimaging for brain maturity and brain injury, (2) hair and fingernails for cortisol and saliva for immune system function, (3) heart rate variability (HRV) for autonomic nervous system function (ANS), (4) Bayley Scales of Infant Development (BSID-III) for cognitive and motor function, (5) a naturalistic play session incorporating kicking, general movement analysis, or the Test of Infant Motor Performance (TIMP) for motor development, and (6) the mobile paradigm for learning, memory, and task-specific coordination. The investigators will look at types of relationships among these measures within each time point for description of development and across each time point for prediction of development. The investigators' core hypotheses are that infants with CCHD will have measurable deficits in cognitive and motor development birth to \\~ 6 months of age when compared with a healthy control group and that a typology developed from neurodevelopmental measures will reliably predict cognitive and motor delay in the first six months of life in infants with CCHD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants are infants born with a complex congenital heart defect.Cardiac defects include, but are not be limited to: atrioventricular canal defect, double outlet right ventricle, hypoplastic left heart syndrome, interrupted aortic arch, pulmonary atresia, tetralogy of Fallot, and transposition of the great arteries.All participants are recruited from Nationwide Children's Hospital in Columbus, OH. Healthy infants will also be enrolled as a comparison group.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 36 weeks gestational age\n* diagnosed with a Complex Congenital Heart Defect\n* have at least one English-speaking adult family member\n\nExclusion Criteria:\n\n* presence of co-existing, non-cardiac congenital anomalies\n* ongoing post-operative cardiac pacing'}, 'identificationModule': {'nctId': 'NCT03104751', 'briefTitle': 'Neurodevelopment in Infants With Complex Congenital Heart Defects', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Neurodevelopment in Infants With Complex Congenital Heart Defects', 'orgStudyIdInfo': {'id': '2015N0040'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants with Complex Congenital Heart Defect', 'description': 'Infants diagnosed a Complex Congenital Heart Defect'}, {'label': 'Comparison/Healthy Infants', 'description': 'Infants born without genetic syndromes or cardiac condition.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Jill Heathcock, MPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}, {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jill Heathcock', 'investigatorAffiliation': 'Ohio State University'}}}}