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ID
Source
Brief title
Health condition
Congenital heart disease
Intra-uterine neurodevelopmental disorders
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
1. Brain perfusion of healthy control fetuses
2. Growth trajectories of brain structures
3. Brain volume of healthy control fetuses
4. Collection of placentas and biomaterial of the umbilical cords for storage for future research. The biomaterials will be stored in the LUMC Biobank Verloskunde
Background summary
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.
Study objective
Fetuses with a congenital heart disease show a delay in cortical maturation especially in the third trimester, in comparison with healthy control cases.
Study design
20-24-28-32 and 36 weeks of gestational age
Birth
Moska Aliasi
+31(0)71 5269199
m.aliasi@lumc.nl
Moska Aliasi
+31(0)71 5269199
m.aliasi@lumc.nl
Inclusion criteria
- 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
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9035 |
| CCMO | NL72889.058.20 |
| OMON | NL-OMON49553 |