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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorUniversity Hospital, Montpellier

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Screening for neurodevelopmental disorders by an advanced practice nurse

    Other intervention

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

Treatment groups

270 Participants
are divided into 1 treatment group
Group A: Screening for neurodevelopmental disorders by an advanced practice nurseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 months (to obtain the neurophysiologist assessment)

Secondary outcomes

1

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.

Time frame
18 months
2

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.

Time frame
4 months (to obtain the neurophysiologist assessment)
3

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.

Time frame
4 months (to obtain the neurophysiologist assessment)
4

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.

Time frame
4 months (to obtain the neurophysiologist assessment)

Other outcomes

Sponsors and contacts

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