NCT06884046 Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
| NCT ID | NCT06884046 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Complex Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2027-02-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-02-06 with a primary completion date of 2027-02-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06884046 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 28 Days, studying Complex Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06884046 currently recruiting?
Yes, NCT06884046 is actively recruiting participants. Contact the research team at laurie.ponteins@chu-bordeaux.fr for enrollment information.
Where is the NCT06884046 trial being conducted?
This trial is being conducted at Pessac, France.
Who is sponsoring the NCT06884046 clinical trial?
NCT06884046 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 40 participants.