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NCT Number: NCT06431269

Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease

Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease

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Key information

Conditions

Congenital Heart Disease in Children Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Mental Disorders Neurodevelopmental Disorders

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitial of Montpellier, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Screening for neurodevelopmental disorders by an advanced practice nurse

Other

Screening for neurodevelopmental disorders by an advanced practice nurse with Ages & Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale

Primary outcomes

  1. 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.

Secondary outcomes

  1. Feasibility of the IPA screening for NDD

    Time frame: 18 months

    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.

  2. Performance (sensibility) of the IPA screening for NDD on the NDD high risk population

    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.

  3. Performance (specificity) of the IPA screening for NDD on the NDD high risk population

    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.

  4. 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)

    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.

  5. 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)

    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. Prevalence of NDD in the high risk population

    Time frame: 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Associate

CONTACT

[email protected]

06 67 33 66 32

Marie VINCENTI, MD

CONTACT

[email protected]

04 67 33 66 39

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: NEURODEV-IPA

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 28, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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