Fetuses with a congenital heart disease show a delay in cortical maturation especially in the third trimester, in comparison with healthy control cases.
ID
Bron
Verkorte titel
Aandoening
Congenital heart disease
Intra-uterine neurodevelopmental disorders
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Brain age of healthy control fetuses, especially in the third trimester (cortical folding of the brain)
2. Speed of maturation of healthy control fetuses, especially in the third trimester
Achtergrond van het onderzoek
Rationale: Congenital heart disease (CHD) is the most prevalent congenital anomaly and accounts for significant (neonatal) mortality and morbidity. Not only cardiovascular and surgical problems can arise, also a high percentage of CHD children suffer from neurodevelopmental disorders. Recent imaging studies found signs of abnormal neurological development already present at birth. However, the precise intrauterine pathophysiology is not known. The current study is designed to analyse the normal fetal neurodevelopment and to collect biomaterial of healthy fetuses for the LUMC Biobank Verloskunde, to serve as a control group for fetuses with congenital heart defects. In the department of fetal medicine of the LUMC, all consecutive CHD fetuses are systematically included in a fetal neurodevelopmental surveillance program (Heart And Neurodevelopmental Program). Data and biomaterial of fetuses with CHD are stored in the LUMC Biobank Verloskunde.
Objective: To study prenatal normal intrauterine cerebral developmental as a comparison for neurodevelopment in fetuses with CHD, to identify possible prognostic factors for abnormal neurodevelopmental outcome in children
with CHD. To collect and store placentas and biomaterial of the umbilical cord of healthy control fetuses in our LUMC Biobank congenital heart disease for future research.
Study design: Single-center, prospective, observational cohort study
Study population: Pregnant women carrying a congenitally normal fetus
Main study parameters/endpoints: brain age, intrauterine development of the brain, speed of maturation
Secondary study parameters/endpoints: brain perfusion, growth trajectories of brain structures, brain volumes, collection of placentas and biomaterial of the umbilical cord for storage in the LUMC Biobank Verloskunde.
Doel van het onderzoek
Fetuses with a congenital heart disease show a delay in cortical maturation especially in the third trimester, in comparison with healthy control cases.
Onderzoeksopzet
20-24-28-32 and 36 weeks of gestational age
Birth
Algemeen / deelnemers
Moska Aliasi
+31(0)71 5269199
m.aliasi@lumc.nl
Wetenschappers
Moska Aliasi
+31(0)71 5269199
m.aliasi@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Singleton pregnancy
- Normal second trimester ultrasound (absence of abnormalities on ultrasound)
- No use of alcohol, drugs or other psychoactive substances during pregnancy
- Age ≥ 18 years
- Gestational age 18-36 weeks
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Obstetric history of intra-uterine growth restriction or intra-uterine fetal demise
- Serious underlying maternal medical condition
- Use of teratogenic medication during pregnancy
- Congenital abnormalities detected in the first year of life
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9035 |
| CCMO | NL72889.058.20 |
| OMON | NL-OMON49553 |