Support for parents of children with congenital heart disease during surgery
Evaluation of the Feasibility of Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
This study is testing a new support program to see if it can help reduce stress for parents of babies with congenital heart disease during their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Pessac, France) |
| Trial ID | NCT06884046 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are parents of fetuses diagnosed with congenital heart disease who will undergo surgery within the first 28 days of life.
Not a fit: Parents who do not understand or read French or those with major psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the well-being of parents and enhance the neurodevelopmental outcomes for their children.
How similar studies have performed: While there is limited data on similar personalized support models, the approach is innovative and may provide new insights into managing parental stress in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pessac, France
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.