Support for parents of children with congenital heart disease during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a personalized support model aimed at reducing parental stress during the neonatal surgical management of congenital heart disease. It focuses on providing comprehensive, multidisciplinary care starting from the antenatal period, addressing the unique challenges faced by families. The intervention includes consultations with a paramedical team and tailored support projects to meet the specific needs of parents. The effectiveness of this approach will be assessed through parental stress evaluations at various stages of the care journey.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Free, informed and signed written consent of the couple or single mother in a single parent setting or by a third person (in case of physical disability of the participant) and the investigator (no later than the day of inclusion and before any examination required by the research).
* Person affiliated or beneficiary of a social security scheme (excluding AME).
* Parents with parental authority.

Exclusion Criteria:

* 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.

Where it's running

• Hôpital Cardiologique Haut-Lévêque
  Pessac, France, France Recruiting

Study contacts

• Study coordinator: Laurie PONTEINS
• Email: laurie.ponteins@chu-bordeaux.fr
• Phone: +33 05 57 65 67 93

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.