NCT06884046

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Complex Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	Personalized support project	1. Presence of a child nurse at the consultation of the anesthesiologist-resuscitator. 2. Antenatal paramedical consultation conducted by a child nurse composed of a semi-structured interview and an evaluation of Parental Stress by the ISP-4 self-questionnaire. 3. Implementation of the personalized support project 4. Self-assessment of parental stress using the ISP-4 self-questionnaire (child admitted to intensive care or resuscitation unit) 5. Application of the personalised support project 6. Self-assessment of parental stress using the ISP-4 self-questionnaire (child discharged from intensive care) 7. Paramedical follow-up consultation with parents (semi-directive interview, ISP-4 self-questionnaire) and assessment of the child's psychomotor development in the child's 6th month of life

Timeline

• Start date: 2025-02-06
• Primary completion: 2027-02-06
• Completion: 2027-02-06
• First posted: 2025-03-19
• Last updated: 2025-03-19

Locations

1 site across 1 country: France