NCT06884046

Brief Summary

Half of children with congenital heart disease develop specific neurodevelopmental disorders. Neurodevelopmental disorders are the leading cause of morbidity in these children. They can be increased by perioperative complications, the family and economic socio-economic environment and the level of parental stress. The stress perceived by parents of children with congenital heart disease varies depending on the time of diagnosis, the organization of care inherent in neonatal management and the type of pathology diagnosed. The main objective is to evaluate the feasibility of a multidisciplinary and personalised model of support for parental stress, from the ante-natal period, in the context of their child's neonatal cardiac surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Feb 2025Feb 2027

Study Start

First participant enrolled

February 6, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2027

Last Updated

March 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

February 25, 2025

Last Update Submit

March 12, 2025

Conditions

Complex Congenital Heart Disease

Keywords

NeurodevelopmentStress parentalParental guidance

Outcome Measures

Primary Outcomes (1)

  • Families participation evaluation

    The participation of families in the proposed accompaniment will be evaluated by the participation rate: number of parents who participated in the study until the last stage of the protocol, number of parents who dropped out of the study and reason.

    at the last protocol visit ( visit 6 - day 180)

Secondary Outcomes (5)

  • Parental stress Evolution

    between visit 1 (day -28) and visit 6 (day 180)

  • Infant development

    at the last protocol visit ( visit 6 - day 180)

  • Evaluation of the healthcare team adherence

    at visit 5 ( day 60 )

  • Evaluation of the healthcare team adherence

    at visit 5 ( day 60 )

  • Personal Support Project Evaluation

    at the last protocol visit ( visit 6 - day 180)

Study Arms (1)

Accompaniment project

EXPERIMENTAL

The experimental intervention envisaged combines specific monitoring and the implementation of a personalised support programme.

Other: Personalized support project

Interventions

Personalized support projectOTHER

1. Presence of a child nurse at the consultation of the anesthesiologist-resuscitator. 2. Antenatal paramedical consultation conducted by a child nurse composed of a semi-structured interview and an evaluation of Parental Stress by the ISP-4 self-questionnaire. 3. Implementation of the personalized support project 4. Self-assessment of parental stress using the ISP-4 self-questionnaire (child admitted to intensive care or resuscitation unit) 5. Application of the personalised support project 6. Self-assessment of parental stress using the ISP-4 self-questionnaire (child discharged from intensive care) 7. Paramedical follow-up consultation with parents (semi-directive interview, ISP-4 self-questionnaire) and assessment of the child's psychomotor development in the child's 6th month of life

Accompaniment project

Eligibility Criteria

Age0 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents whose fetus has congenital heart disease diagnosed in antenatal, which will be operated in the neonatal period (between 0 and 28 days of life) within our sector.
  • Parents followed in the congenital heart disease sector of the University Hospital of Bordeaux as soon as the diagnosis is announced in antenatal.
  • Person affiliated or beneficiary of a social security scheme (excluding AME).
  • Parents with parental authority.

You may not qualify if:

  • Parents who do not understand or read French and cannot be accompanied by a third party for translation.
  • Parents with major psychiatric disorders.
  • Parents deprived of liberty due to ongoing legal proceedings.
  • Parents under guardianship or curatorship or unable to personally express consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cardiologique Haut-Lévêque

Pessac, France, 33604, France

RECRUITING

Central Study Contacts

Laurie PONTEINS

CONTACT

+33 05 57 65 67 93laurie.ponteins@chu-bordeaux.fr

Amandine RUISSEL

CONTACT

+33 05 57 62 32 29recherche.cardioped@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 19, 2025

Study Start

February 6, 2025

Primary Completion (Estimated)

February 6, 2027

Study Completion (Estimated)

February 6, 2027

Last Updated

March 19, 2025

Record last verified: 2025-02

Locations

FR(1)