Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases (Et APRéS Ca)

March 12, 2025 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Accompaniment project
The experimental intervention envisaged combines specific monitoring and the implementation of a personalised support programme.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Families participation evaluation
Time Frame: at the last protocol visit ( visit 6 - day 180)
The participation of families in the proposed accompaniment will be evaluated by the participation rate: number of parents who participated in the study until the last stage of the protocol, number of parents who dropped out of the study and reason.
at the last protocol visit ( visit 6 - day 180)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental stress Evolution
Time Frame: between visit 1 (day -28) and visit 6 (day 180)
Evolution of parental stress by the ISP-4 self-questionnaire (Parental Stress Index)
between visit 1 (day -28) and visit 6 (day 180)
Infant development
Time Frame: at the last protocol visit ( visit 6 - day 180)
Evolution of the overall score of the Bayley-4 scale (Bayley Infant and Young Child Development Scales) at 6 months of life compared to a literature cohort (neonate child).
at the last protocol visit ( visit 6 - day 180)
Evaluation of the healthcare team adherence
Time Frame: at visit 5 ( day 60 )
Evaluation of the adherence of the healthcare team to this new model via a Likert scale administered at the discharge of the child, and an analysis of the large items found on the accompanying sheets
at visit 5 ( day 60 )
Evaluation of the healthcare team adherence
Time Frame: at visit 5 ( day 60 )
Evaluation of the adherence of the healthcare team to this new model via an EVA scale administered at the discharge of the child, and an analysis of the large items found on the accompanying sheets
at visit 5 ( day 60 )
Personal Support Project Evaluation
Time Frame: at the last protocol visit ( visit 6 - day 180)
Evaluation of the Personal Support Project by families using an Visual Analogue Scale.
at the last protocol visit ( visit 6 - day 180)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2025

Primary Completion (Estimated)

February 6, 2027

Study Completion (Estimated)

February 6, 2027

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2022/78
  • 2024-A00681-46 (Other Identifier: ID-RCB number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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