Actively Recruiting

Phase Not Applicable
Age: 0Days - 28Days
All Genders
NCT06884046

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

Led by University Hospital, Bordeaux · Updated on 2025-03-19

40

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Days - 28Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Parents whose fetus has congenital heart disease diagnosed before birth, requiring surgery within 28 days after birth
  • Parents followed in the congenital heart disease sector of the University Hospital of Bordeaux from diagnosis
  • Free, informed, and signed consent from both parents or single mother (or authorized third person if needed) before any study procedures
  • Person affiliated with or beneficiary of a social security scheme (excluding AME)
  • Parents with legal parental authority
Not Eligible

You will not qualify if you...

  • Parents who do not understand or read French and cannot be assisted by a translator
  • Parents with major psychiatric disorders
  • Parents currently deprived of liberty due to legal proceedings
  • Parents under guardianship, curatorship, or unable to give personal consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hôpital Cardiologique Haut-Lévêque

Pessac, France, France, 33604

Actively Recruiting

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Research Team

L

Laurie PONTEINS

CONTACT

A

Amandine RUISSEL

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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