## Protocol Section
### Identification Module
**NCT ID:** NCT06431269

**Acronym:** NEURODEV-IPA

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

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

#### Organization Study ID Info
**ID:** 21_0291
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Montpellier
#### Secondary ID Infos
**Domain:** 2024-A00552-45
**ID:** ID-RCB
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-25

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Montpellier

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Congenital Heart Disease in Children

- Neurodevelopmental Disorders

**Keywords:**

- congenital heart disease

- neurodevelopmental screening

- advanced practice nurse

- organization of care

- neuropsychological assessment

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 270

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Screening for neurodevelopmental disorders by an advanced practice nurse

**Label:** Screening for neurodevelopmental disorders by an advanced practice nurse

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Screening for neurodevelopmental disorders by an advanced practice nurse

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

**Name:** Screening for neurodevelopmental disorders by an advanced practice nurse

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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:** Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied

**Time Frame:** 4 months (to obtain the neurophysiologist assessment)

#### Secondary Outcomes

**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:** Feasibility of the IPA screening for NDD

**Time Frame:** 18 months

**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 (sensibility) of the IPA screening for NDD on the NDD high risk population

**Time Frame:** 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

**Time Frame:** 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

**Time Frame:** 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

**Time Frame:** 4 months (to obtain the neurophysiologist assessment)

**Measure:** Prevalence of NDD in the high risk population

**Time Frame:** 18 months

### Eligibility Module

**Eligibility Criteria:** 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:

* Genetic or poly-malformative syndrome with usual neurodevelopmental care (CAMPS-type care network)
* Neurodevelopmental status evaluation within the last 6 months.

**Maximum Age:** 5 Years

**Minimum Age:** 1 Year

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** m-vincenti@chu-montpellier.fr

**Name:** Marie VINCENTI, MD

**Phone:** 04 67 33 66 39

**Role:** CONTACT

**Contact 2:**

**Email:** recherche-clinique-ccp@chu-montpellier.fr

**Name:** Clinical Research Associate

**Phone:** 06 67 33 66 32

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Montpellier

**Contacts:**

***Contact 1:***

- **Email:** m-vincenti@chu-montpellier.fr

- **Name:** Marie VINCENTI, MD

- **Phone:** 04 67 33 66 39

- **Role:** CONTACT

**Country:** France

**Facility:** University Hospitial of Montpellier

**Zip:** 34295

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000018376

- Term: Cardiovascular Abnormalities

- ID: D000000013

- Term: Congenital Abnormalities

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M9419

- Name: Heart Diseases

- Relevance: HIGH

- As Found: Heart Disease

- ID: M9418

- Name: Heart Defects, Congenital

- Relevance: HIGH

- As Found: Congenital Heart Disease

- ID: M30644

- Name: Neurodevelopmental Disorders

- Relevance: HIGH

- As Found: Neurodevelopmental Disorders

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006331

- Term: Heart Diseases

- ID: D000006330

- Term: Heart Defects, Congenital

- ID: D000065886

- Term: Neurodevelopmental Disorders

### Misc Info Module

- Version Holder: 2024-05-31
