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

NCT ID: NCT06884046

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-06
• Study Completion Date: 2027-02-06

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.

Conditions

Complex Congenital Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Accompaniment project

The experimental intervention envisaged combines specific monitoring and the implementation of a personalised support programme.

Group Type: EXPERIMENTAL

Personalized support project

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Cardiologique Haut-Lévêque

Pessac, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Laurie PONTEINS

Role: CONTACT

laurie.ponteins@chu-bordeaux.fr

+33 05 57 65 67 93 ext. +33

Amandine RUISSEL

Role: CONTACT

recherche.cardioped@chu-bordeaux.fr

+33 05 57 62 32 29 ext. +33

Facility Contacts

Laurie PONTEINS

Role: primary

laurie.ponteins@chu-bordeaux.fr

+33 05 57 65 67 93 ext. +33

Other Identifiers

2024-A00681-46

Identifier Type: OTHER

Identifier Source: secondary_id

CHUBX 2022/78

Identifier Type: -

Identifier Source: org_study_id