Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
Key facts
- Who runs it
- University Hospital, Bordeaux
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 6 Feb 2025
- Expected to end
- 6 Feb 2027
- Type of study
- Interventional
- Treatments tested
- Personalized support project
- Record updated
- 19 March 2025
Who can take part
- Age
- 0 days to 28 days
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Parents with major psychiatric disorders
- Parents who do not understand or read French and cannot be accompanied by a third party for translation
- Parents deprived of liberty due to ongoing legal proceedings
- Parents under guardianship or curatorship or unable to personally express consent
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Accompaniment projectTreatment being tested
The experimental intervention envisaged combines specific monitoring and the implementation of a personalised support programme.
Treatment: Personalized support project
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Feasibility of Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
- Record updated
- 19 March 2025