Support for Parents of Children with Heart Surgery
Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
Recruiting
N/AInterventional Study
Complex Congenital Heart Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
0 Days – 28 Days
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
40 (estimated)
Sponsor
University Hospital, Bordeaux · Other
Who this trial is looking for
This trial is looking for parents of babies with congenital heart disease who need surgery soon after birth. Participating involves providing consent to receive support tailored to help manage parental stress during this difficult time.
Are You a Good Fit for This Trial?
You may be able to join if
I am a parent of a fetus diagnosed with congenital heart disease.
My child is scheduled for heart surgery within the first 28 days of life.
I am being followed by the University Hospital of Bordeaux for my child's condition.
I can give my consent or have a legal guardian do so on my behalf.
I am covered by a social security scheme.
You may not be able to join if
I do not understand or cannot read French and have no one to help translate.
I have major psychiatric disorders.
I am currently in prison due to legal issues.
I am under guardianship or cannot personally give consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 dep…
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.
Trial Locations
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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…
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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