Status:
RECRUITING
Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Complex Congenital Heart Disease
Eligibility:
All Genders
Up to 28 years
Phase:
NA
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 b...
Detailed Description
Congenital heart disease (CC) is the most common congenital malformation. Every year, 8 newborns out of 1000 are affected by these pathologies worldwide and about 20% of them will require intervention...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 6 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06884046
Start Date
February 6 2025
End Date
February 6 2027
Last Update
March 19 2025
Active Locations (1)
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1
Hôpital Cardiologique Haut-Lévêque
Pessac, France, France, 33604