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

RecruitingOBSERVATIONAL
Enrollment

450

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

August 28, 2027

Study Completion Date

August 28, 2027

Conditions
Heart Disease CongenitalNeurodevelopmental Disorder
Interventions
BEHAVIORAL

Neurodevelopmental assessment (Bayley-IV)

Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist

OTHER

Biological sampling

"The samples to be collected at delivery will include:~* A 4 ml maternal blood sample in an EDTA tube for lipidomic and metabolomic analyses at delivery~* A 6 ml maternal blood sample in an EDTA tube (2 tubes of 3 ml) for genetic analysis~* A 4 ml venous cord blood sample in an EDTA tube for transcriptomic and epigenetic analysis; and a 2 ml EDTA tube for metabolomic/lipidomic analysis~* Samples from fresh placenta for transcriptomic, epigenetic, metabolomic, and lipidomic analyses~* A meconium sample collected as soon as possible after birth in a dry tube for microbiome analysis~During hospitalization for the cardiac surgery:~* Genome analysis samples will be collected from the father and the infant. These samples will be taken in two EDTA tubes of 3 ml each.~* Perioperative neurobiomarker samples will be collected (one EDTA tube of 500 μL preoperatively and postoperatively on Day 1 and 2).~At 1 month, a stool sample will be collected from the infants for microbiome analysis."

BEHAVIORAL

ELFE dietary questionnaire

Questionnaire on diet and lifestyle during pregnancy (only for the mother)

BEHAVIORAL

Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised)

The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events.

OTHER

Data collection for the study (Cardiovascular, developemental, fetal, pregnancy, MRI)

"* Cardiovascular follow-up data collection~* Developmental follow-up data collection~* Collection of postoperative brain MRI data, scheduled between Day 5 post-surgery and the end of the hospital stay~* Collection of data on pregnancy exposure, obstetric events, and delivery data.~* Collection of fetal ultrasound data (T2 and T3).~* Collection of fetal echocardiography data (T2 and T3)."

Trial Locations (3)

44093

RECRUITING

Nantes University Hospital, Nantes

Unknown

NOT_YET_RECRUITING

AP-HM, Marseille

NOT_YET_RECRUITING

CHRU Tours, Tours

All Listed Sponsors
collaborator

Pays de la Loire Laboratory of Psychology (LPPL)

UNKNOWN

collaborator

Physiopathology of Nutritional Adaptations Joint Research Unit (UMR PhAN)

UNKNOWN

collaborator

Institut du thorax, INSERM UMR1087

UNKNOWN

lead

Nantes University Hospital

OTHER