Clinical trial NCT06884046: Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
Official title: Evaluation of the Feasibility of Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Congenital Heart Disease
Keywords: Neurodevelopment
Stress parental
Parental guidance
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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 in the first days of life. The complexity of heart disease, factors intrinsic to the patient as well as surgical techniques can be the cause of neurological abnormalities. Indeed, 43% of these CC newborns are already carriers of a cerebral anomaly in the perinatal period.

Neurodevelopmental disorders (NDD) 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 CC varies depending on the time of diagnosis, the type of pathology and the organization of neonatal care.

It is essential to accompany these parents with personalized care. It must be comprehensive, multidisciplinary and empathetic, with the aim of improving the neurodevelopmental prognosis of these children, and family well-being.

Through this project of accompaniment proposed from the antenatal, we innovate by integrating consultations by the paramedical team of the resuscitation, the implementation of a personalized support project that meets the expectations and needs of families for better care of their child. A parental stress assessment will be carried out at 4 times of the family care journey.

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.

Primary outcomes:
measure: Families participation evaluation
timeFrame: at the last protocol visit ( visit 6 - day 180)
Secondary outcomes:
measure: Parental stress Evolution
timeFrame: between visit 1 (day -28) and visit 6 (day 180)
measure: Infant development
timeFrame: at the last protocol visit ( visit 6 - day 180)
measure: Evaluation of the healthcare team adherence
timeFrame: at visit 5 ( day 60 )
measure: Evaluation of the healthcare team adherence
timeFrame: at visit 5 ( day 60 )
measure: Personal Support Project Evaluation
timeFrame: at the last protocol visit ( visit 6 - day 180)
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital Cardiologique Haut-Lévêque
Study officials:
References: