Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-04 @ 7:50 AM
Study NCT ID:
NCT03045757
Status:
TERMINATED
Last Update Posted:
2024-10-04
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Dysphagia in Neonates With CHD
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': 60}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Dr. Fogel left the organization, and no other clinician was available to continue the study. Data was never collected for the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-02-04', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral motor skills of infants with CHD utilizing the NOMAS', 'timeFrame': '1 year'}, {'measure': 'Type and quality of oral motor skills of infants with CHD before cardiothoracic surgery as measured by NOMAS', 'timeFrame': '1 year'}, {'measure': 'Type and quality of feeding readiness using the Infant Driven Feeding Scales with infants with CHD after cardiothoracic surgery', 'timeFrame': '1 year'}, {'measure': 'Type and Quality of oral motor skills in newborn infants as measured by NOMAS', 'timeFrame': '1 year'}, {'measure': 'Type and quality of oral motor skills of infants with CHD after cardiothoracic surgery as measured by NOMAS', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysphagia of Newborn']}, 'descriptionModule': {'briefSummary': 'The overall goal of this study is to describe the oral motor skills of neonates born with congenital heart defects, both before and after cardiac surgery, and to evaluate current measures of feeding motor skills and feeding readiness in this population using the Neonatal Oral Motor Assessment Scale (NOMAS) and the Infant Driven Feeding Scale.\n\nThe specific aims are to:\n\n1. Describe the oral motor skills of infants with CHD before surgery as compared with normal full-term newborn (\\>37 weeks) using the NOMAS\n2. Describe the oral motor skills of infants with CHD after surgery as compared with those same infants before surgery using the NOMAS.\n3. Determine if the current Infant Driven Feeding Readiness Scale appropriately identifies which children with CHD are ready for oral feeding. (A. Feeding Readiness Scale, B. Quality of Nippling Scale at the 1st post- operative feeding evaluation)\n4. Describe the unique characteristics of oral motor skills in infants with CHD (ie. Wide jaw excursions, poor latch, etc.) Our hypothesis is that infants with CHD will have dysfunctional sucking patterns before surgical repair as compared to normal newborns. This dysfunctional sucking pattern in infants with CHD will have worsened post-surgery as compared to pre-surgery. In addition, the Infant Driven Feeding Scale will be utilized to predict that many infants with CHD will not be ready for oral feedings, however most of those patients will go on to successfully take oral feedings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy newborns and neonates with CHD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full-term newborns with normal physical exam that are delivered \\> 37 weeks gestation (healthy newborn arm).\n\nor\n\n* Newborn with CHD born \\> 37 weeks gestation, are hemodynamically stable and who require surgical correction in the first 30 days of life (CHD arm).\n\nExclusion Criteria:\n\n* Full-term newborn arm\n* Newborn admitted into the NICU\n* Genetic syndromes\n* Congenital abnormalities or signs of developmental delay\n\n ยท Infants with CHD arm\n* Newborn requiring intubation prior to evaluation (Note: Infants with CHD with genetic or other malformations not specifically mentioned will not be excluded due to their prevalence in this population)\n* Down Syndrome\n* Trisomy 13, Trisomy 18\n* Congenital anomalies of facial structure or musculature specifically cleft lip, hard or soft palate'}, 'identificationModule': {'nctId': 'NCT03045757', 'briefTitle': 'Evaluating Dysphagia in Neonates With CHD', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Evaluating Oral Motor Skills of Neonates Requiring Congenital Heart Surgery and the Impact on Oral Feeding Readiness', 'orgStudyIdInfo': {'id': '6540'}, 'secondaryIdInfos': [{'id': 'K5900376', 'type': 'OTHER', 'domain': 'Advocate Health Care'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Newborn', 'description': 'Healthy Newborn'}, {'label': 'CHD Neonates', 'description': 'Neonates born with CHD before and after surgical repair'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': "Advocate Children's Hospital", 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}], 'overallOfficials': [{'name': 'Jennifer L Fogel, MSCCC-SLP/L', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advocate Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}