Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-31 @ 3:58 AM
Study NCT ID:
NCT01749059
Status:
COMPLETED
Last Update Posted:
2016-12-19
First Post:
2012-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-01-25', 'releaseDate': '2018-08-14'}], 'estimatedResultsFirstSubmitDate': '2018-08-14'}}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6147}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-16', 'studyFirstSubmitDate': '2012-12-11', 'studyFirstSubmitQcDate': '2012-12-12', 'lastUpdatePostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'True Positive Rate', 'timeFrame': 'One year follow-up', 'description': 'The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have CCHD.'}, {'measure': 'False Positive Rate', 'timeFrame': 'One year follow-up', 'description': 'The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.'}, {'measure': 'True Negative Rate', 'timeFrame': 'One year follow-up', 'description': 'The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.'}, {'measure': 'False Negative Rate', 'timeFrame': 'One year follow-up', 'description': 'The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have heart defects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing newborns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates known to have a congenital heart defect at the time of screening.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Documentation of informed consent and authorization.\n2. Full term and late preterm newborns (EGA 35-44 weeks)\n3. On room air\n4. Neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth\n5. Parents agree to follow-up contact post discharge\n\nExclusion Criteria:\n\n1. On supplemental oxygen\n2. Admitted to the Neonatal Intensive Care Unit\n3. Parents do not agree to follow-up\n4. Greater than 30 days of age'}, 'identificationModule': {'nctId': 'NCT01749059', 'acronym': 'CCHD', 'briefTitle': 'The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Pediatrix'}, 'officialTitle': 'The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease', 'orgStudyIdInfo': {'id': 'PDX-003-11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Congenital Heart Defect'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08638', 'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Capital Health Regional Medical Center - Pediatrix Medical Group', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}], 'overallOfficials': [{'name': 'Reese H Clark, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatrix'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pediatrix', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-08-14', 'type': 'RELEASE'}, {'date': '2019-01-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Pediatrix'}}}}