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Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases

RecruitingNAAges 0 Days - 28 DaysAllUniversity Hospital, Bordeaux
NCT06884046 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Personalized support project
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Where

1 site
Hôpital Cardiologique Haut-Lévêque
Pessac, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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