Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-03 @ 7:07 PM
Study NCT ID:
NCT06431269
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2024-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-25', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied', 'timeFrame': '4 months (to obtain the neurophysiologist assessment)', 'description': "This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening."}], 'secondaryOutcomes': [{'measure': 'Feasibility of the IPA screening for NDD', 'timeFrame': '18 months', 'description': "This rate will be calculated by dividing the complete IPA screenings (including HAS and the ASQ-3 parent's questionnaire) and children coming to the Complex Congenital Heart Defects consultation during the study period."}, {'measure': 'Performance (sensibility) of the IPA screening for NDD on the NDD high risk population', 'timeFrame': '4 months (to obtain the neurophysiologist assessment)', 'description': "This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening."}, {'measure': 'Performance (specificity) of the IPA screening for NDD on the NDD high risk population', 'timeFrame': '4 months (to obtain the neurophysiologist assessment)', 'description': "This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening."}, {'measure': 'Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population', 'timeFrame': '4 months (to obtain the neurophysiologist assessment)', 'description': "This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening."}, {'measure': 'Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population', 'timeFrame': '4 months (to obtain the neurophysiologist assessment)', 'description': "This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening."}, {'measure': 'Prevalence of NDD in the high risk population', 'timeFrame': '18 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['congenital heart disease', 'neurodevelopmental screening', 'advanced practice nurse', 'organization of care', 'neuropsychological assessment'], 'conditions': ['Congenital Heart Disease in Children', 'Neurodevelopmental Disorders']}, 'descriptionModule': {'briefSummary': 'Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease', 'detailedDescription': 'Congenital heart disease (CHD) is the leading cause of birth defects. Over 90% of children born with CHD reach adulthood. 50% of them will develop a neurodevelopmental disorder (NDD) that could affect life and long-term prognosis, including scholar and social integration and health related quality of life.\n\nIn France, there is a lack of medical resources to screen NDD in this population and to refer patients for appropriate and early treatment.\n\nInvestigators plan to propose a systematic early screening of NDD by an Advanced Practice Nurse (APN) during the usual cardiac follow-up. Children with CHD aged 1 to 5 will be included. If NDD is suspected, the patient will be referred to a neuropsychologist for NDD diagnosis confirmation and management planning. Patients with higher NDD risks (neonatal cardiac surgery) will benefit from a systematic neuropsychologist evaluation.\n\nThis study will investigate the feasibility and performance of an APN screening in this NDD-high risk population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Congenital heart disease with stable status defined by last operation \\>3 months, no cardiac decompensation in the last 3 months, no planned surgery within 6 months after the inclusion\n* Cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life,\n* Patient aged 1 to 5 years.\n* No previous medical diagnosis of NDD\n* Parental or legal guardian's consent.\n* Social security affiliation (for France only)\n\nExclusion Criteria:\n\n* Patients with a genetic or poly-malformative syndrome with known neurological impairment.\n* Neurodevelopmental disorder already known/treated\n* Neurodevelopmental status evaluation within the last 6 months."}, 'identificationModule': {'nctId': 'NCT06431269', 'acronym': 'NEURODEV-IPA', 'briefTitle': 'Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease', 'orgStudyIdInfo': {'id': 'RECHMPL21_0291'}, 'secondaryIdInfos': [{'id': 'ID-RCB', 'type': 'REGISTRY', 'domain': '2024-A00552-45'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening for neurodevelopmental disorders by an advanced practice nurse', 'interventionNames': ['Other: Screening for neurodevelopmental disorders by an advanced practice nurse']}], 'interventions': [{'name': 'Screening for neurodevelopmental disorders by an advanced practice nurse', 'type': 'OTHER', 'description': 'Screening for neurodevelopmental disorders by an advanced practice nurse with Ages \\& Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale', 'armGroupLabels': ['Screening for neurodevelopmental disorders by an advanced practice nurse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie VINCENTI, MD', 'role': 'CONTACT', 'email': 'm-vincenti@chu-montpellier.fr', 'phone': '04 67 33 66 39'}], 'facility': 'University Hospitial of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34250', 'city': 'Palavas-les-Flots', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie Guillaumont, MD', 'role': 'CONTACT'}], 'facility': 'Institut Marin Saint-Pierre', 'geoPoint': {'lat': 43.52974, 'lon': 3.93043}}, {'zip': '33600', 'city': 'Pessac', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal Amedro, MD', 'role': 'CONTACT'}], 'facility': 'CHU Bordeaux Haut-Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'centralContacts': [{'name': 'Marie VINCENTI, MD', 'role': 'CONTACT', 'email': 'm-vincenti@chu-montpellier.fr', 'phone': '04 67 33 66 39'}, {'name': 'Clinical Research Associate', 'role': 'CONTACT', 'email': 'recherche-clinique-ccp@chu-montpellier.fr', 'phone': '06 67 33 66 32'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}