450
Participants
Start Date
February 28, 2025
Primary Completion Date
August 28, 2027
Study Completion Date
August 28, 2027
Neurodevelopmental assessment (Bayley-IV)
Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist
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."
ELFE dietary questionnaire
Questionnaire on diet and lifestyle during pregnancy (only for the mother)
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.
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)."
RECRUITING
Nantes University Hospital, Nantes
NOT_YET_RECRUITING
AP-HM, Marseille
NOT_YET_RECRUITING
CHRU Tours, Tours
Pays de la Loire Laboratory of Psychology (LPPL)
UNKNOWN
Physiopathology of Nutritional Adaptations Joint Research Unit (UMR PhAN)
UNKNOWN
Institut du thorax, INSERM UMR1087
UNKNOWN
Nantes University Hospital
OTHER