Congenital Heart Disease in ChildrenNEURODEV-IPANCT06431269
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
A study testing Screening for neurodevelopmental disorders by an advanced practice nurse in people with Congenital Heart Disease in Children and Neurodevelopmental Disorders, run by University Hospital, Montpellier at 3 sites in France.
Trial summary
Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Congenital Heart Disease in Children, Neurodevelopmental Disorders
- What is being tested?
- Screening for neurodevelopmental disorders by an advanced practice nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 3 sitesFrance
- Study dates
- 31 May 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life,
- Patient aged 1 to 5 years.
- No previous medical diagnosis of NDD
- Parental or legal guardian's consent.
- Social security affiliation (for France only)
Who cannot join
- Patients with a genetic or poly-malformative syndrome with known neurological impairment.
- Neurodevelopmental disorder already known/treated
- Neurodevelopmental status evaluation within the last 6 months.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
University Hospitial of Montpellier
Montpellier, 34295
Marie VINCENTI, MD, 04 67 33 66 39, m-vincenti@chu-montpellier.fr
- Not yet recruiting
Institut Marin Saint-Pierre
Palavas-les-Flots, 34250
Sophie Guillaumont, MD
- Not yet recruiting
CHU Bordeaux Haut-Lévêque
Pessac, 33600
Pascal Amedro, MD
About this study
Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease
Read the detailed description
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.
In France, there is a lack of medical resources to screen NDD in this population and to refer patients for appropriate and early treatment.
Investigators 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.
This study will investigate the feasibility and performance of an APN screening in this NDD-high risk population.
- Being tested
- Screening for neurodevelopmental disorders by an advanced practice nurse
- Keywords
- congenital heart disease, neurodevelopmental screening, advanced practice nurse, organization of care, neuropsychological assessment
- Medical subject headings
- Neurodevelopmental Disorders, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for neurodevelopmental disorders by an advanced practice nurseOther
Screening for neurodevelopmental disorders by an advanced practice nurse with Ages \& Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale
| Study group | Role | What they receive |
|---|---|---|
| Screening for neurodevelopmental disorders by an advanced practice nurse | Experimental | Not described Receives: Other: Screening for neurodevelopmental disorders by an advanced practice nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied
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.
Measured: 4 months (to obtain the neurophysiologist assessment)
Secondary outcomes (6)
Feasibility of the IPA screening for NDD
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.
Measured: 18 months
Performance (sensibility) of the IPA screening for NDD on the NDD high risk population
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.
Measured: 4 months (to obtain the neurophysiologist assessment)
Performance (specificity) of the IPA screening for NDD on the NDD high risk population
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.
Measured: 4 months (to obtain the neurophysiologist assessment)
Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population
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.
Measured: 4 months (to obtain the neurophysiologist assessment)
Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population
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.
Measured: 4 months (to obtain the neurophysiologist assessment)
Prevalence of NDD in the high risk population
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start31 May 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431269
- Sponsor's protocol ID
- RECHMPL21_0291
- Other IDs
- ID-RCB
- Acronym
- NEURODEV-IPA
- Status last verified
- Jun 2025
- First submitted
- 17 May 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06431269
- Acronym / sponsor ID
- NEURODEV-IPA / RECHMPL21_0291
- Keywords
- congenital heart disease, neurodevelopmental screening, advanced practice nurse, organization of care, neuropsychological assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease
Detailed description
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.
In France, there is a lack of medical resources to screen NDD in this population and to refer patients for appropriate and early treatment.
Investigators 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.
This study will investigate the feasibility and performance of an APN screening in this NDD-high risk population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening for neurodevelopmental disorders by an advanced practice nurse | Experimental | Other: Screening for neurodevelopmental disorders by an advanced practice nurse |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
- Cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life,
- Patient aged 1 to 5 years.
- No previous medical diagnosis of NDD
- Parental or legal guardian's consent.
Key exclusion criteria (3 listed)
- Patients with a genetic or poly-malformative syndrome with known neurological impairment.
- Neurodevelopmental disorder already known/treated
- Neurodevelopmental status evaluation within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for neurodevelopmental disorders by an advanced practice nurseScreening for neurodevelopmental disorders by an advanced practice nurse with Ages \& Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale | Other | Screening for neurodevelopmental disorders by an advanced practice nurse |
Primary outcome
Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied
Time frame: 4 months (to obtain the neurophysiologist assessment)
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.
6 secondary outcomes
Feasibility of the IPA screening for NDD
Time frame: 18 months
Performance (sensibility) of the IPA screening for NDD on the NDD high risk population
Time frame: 4 months (to obtain the neurophysiologist assessment)
Performance (specificity) of the IPA screening for NDD on the NDD high risk population
Time frame: 4 months (to obtain the neurophysiologist assessment)
Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population
Time frame: 4 months (to obtain the neurophysiologist assessment)
Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population
Time frame: 4 months (to obtain the neurophysiologist assessment)
Prevalence of NDD in the high risk population
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for neurodevelopmental disorders by an advanced practice nurse in people with Congenital Heart Disease in Children and Neurodevelopmental Disorders, run by University Hospital, Montpellier at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie VINCENTI, MD (04 67 33 66 39, m-vincenti@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied (time frame: 4 months (to obtain the neurophysiologist assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.