Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal

MI-összefoglaló

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The trial is looking for unborn babies with a serious heart defect found before birth, and their biological parents. The study follows the babies' development after birth.

Életkor

Unborn babies (fetuses), followed after birth, and their parents.

Nem

All

A betegség stádiuma

A heart defect present from birth, found before birth. It must be serious enough to need heart surgery in the first three months of life.

A részvétel fő kizáró okai

• Parents are considering a medical end to the pregnancy
• A genetic condition or a syndrome with other birth defects found before joining
• Parents not covered by social security or a similar system
• Parents who do not understand French well
• No written consent from both parents

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

Congenital heart defects (CHD), as the leading cause of birth defects, affect 12 million people globally and approximately 41,000 newborns each year in Europe. CHD presents a significant public health concern due to its association with high morbidity and mortality rates across the lifespan. Over 50% of infants born with critical CHD will develop neurodevelopmental disorders (NDD), requiring specialized care and impacting their quality of life. NDDs, involving early and persistent disruptions in cognitive, emotional, and behavioral development due to abnormal brain development, are highly variable. They may impact language, learning, motor skills, intellectual efficiency, social cognition, attention, memory, and executive functions, often accompanied by psychosocial difficulties. These hidden disabilities constitute the primary long-term sequelae of CHD, surpassing even cardiovascular complications in impact, and affect children who often undergo multiple cardiac surgeries during early childhood. NDDs are associated not only with complex CHDs but also with simpler CHDs that are repaired in early childhood and considered 'cured.'

A vizsgálat csoportja

• Study population (Newborns with congenital heart defects and their two parents)

  The study population will consist of 150 fetuses with a prenatally diagnosed critical congenital heart defect (CHD), at high risk of developing developmental delays, and their two parents.

  Kezelés: Neurodevelopmental assessment (Bayley-IV), Biological sampling, ELFE dietary questionnaire, Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised) és Data collection for the study (Cardiovascular, developemental, fetal, pregnancy, MRI)