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Search / Trial NCT06884046

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

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Mar 12, 2025

Trial Information

Current as of April 23, 2025

Recruiting

Keywords

Neurodevelopment Stress Parental Parental Guidance

ClinConnect Summary

This clinical trial is looking at ways to help parents manage their stress when their newborns have congenital heart disease, a serious condition affecting the heart's structure that may require surgery shortly after birth. The study aims to create a supportive program that offers personalized help to parents, starting from the time they learn about their child's diagnosis before birth and continuing through the baby's surgery. It's important because many children with congenital heart disease face challenges in their development, and parental stress can make these issues worse.

To participate in the trial, parents need to have a baby with congenital heart disease that will be operated on within the first 28 days of life, and they must be receiving care from the University Hospital of Bordeaux. Eligible parents must also understand and read French, as well as be able to provide written consent. Throughout the trial, parents can expect to receive tailored support aimed at helping them cope with their stress during this challenging time. This trial is currently recruiting participants, and it's a great opportunity for families to access support while contributing to important research.

Gender

ALL

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.

About University Hospital, Bordeaux

The University Hospital of Bordeaux is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the institution integrates cutting-edge scientific inquiry with patient care, fostering an environment that encourages collaboration among multidisciplinary teams. With a commitment to improving treatment outcomes and enhancing patient safety, the University Hospital of Bordeaux plays a pivotal role in the development of new therapies and medical technologies, contributing significantly to the global medical community.

Locations

Pessac, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported