Applicability of fetal brain imaging techniques for clinical purposes.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Congenital and peripartum neurological conditions
- Maternal complications of pregnancy
Synonym
Sponsors and support
Intervention
Outcome measures
Primary outcome
What is the added value of transvaginal ultrasound or MRI to abdominal
ultrasound in a fetus at thig risk of deveoping brain damage in the second and
third trimester of pregnancy.
Secondary outcome
What is the prevalence of changes visible on antenatal ultrasound in the areas
in the brain that are prone to hypoxic ischemic damage after birth.
What is the evolution of these changes over time before and after birth.
Which antenatal ultrasound findings are associated with abnormal neurological
development until five years of age.
At which gestational age can brain damage best be determined with
transabdominal and transvaginal ultrasound and MRI.
Which brain imaging procedures have the best predictive value for the
neurological outcome at two and five uears of age and how are they related
cost-effectively.
Background summary
Title: Fetal brain imaging in fetuses at high risk of acquired anomalies
Ultrasonography and Magnetic Resonance Imaging (MRI) are techniques of which
the application is no longer limited to the examination of early and later
brain damege of the neonate since it can also successfully be applied in the
fetus. Despite this fact and the knowledge that the majority of early brain
damege does nog originate from peripartum events bur earlier before birth,
these techniques have nog yet been compared systemetically to examine the
prevalence of brain damage in fetuses at high risk. First it has to be examined
whether abnormal findings before birth persist with consequences for the later
neurological outcome, or are transient , due to the plasticity of the young
brain. Even physiological phenomena can be found mimicking sighns that may be
considered abnormal in the neonate.
Study objective
Applicability of fetal brain imaging techniques for clinical purposes.
Study design
A pregnant woman will be invited for the study when the inclusion criteria are
fullfilled. After informed consent the study starts. The study consists of
fetal brain imaging of the pregnant women by means of transabdominal and
transvaginal sonography at inclusion and two weekly thereafter until birth.
MRI is performed once before birth. After birth the sonographic brain imaging
is repeated in the neonate and MRI is performed once at term age. Neurological
follow-up of the neonated is performed at term age, 1, 2, and 5 years.
Study burden and risks
The moment a pregnant women is exposed to a risk that may cause fetal brain
damage she is invited to participate in the study.
There is no risk involved in the participation of this study.
The nature of the study involves a longitudinal examination of the fetal brain
by means of sonographic examination until birth and once an MRI of the fetal
brain. The burden will be limited by combining the sonographic examinations
with the regular check-ups. The neonate will be examined sonographically within
24 hours after birth and weekly during the three weeks thereafter and one MRI
at term age. The neurological examination will be performed at term age, 1, 2,
and 5 years of age.
The benifit will be the continuity of the brain investigations by one
investigator and multidisciplinary team discussing the findings. In case of
unexpected findings the parents will be informed.
Boelelaan 1117
1081HV
NL
Boelelaan 1117
1081HV
NL
Listed location countries
Inclusion criteria
zwangeren waarbij een infectie is aangetoond (toxoplasmose, cytomegalie), trauma hebben ondergaan of trombocytopenie (allo-immuun) of bij de foetus een groeirestrictie is aangetoond onder de 10de percentiel voor 30 weken zwangerschapsduur, hydrops (verdacht voor anemie, arythmie, parvo virus infectie of hydrothorax), monochriale tweeling, echoscopische hersenbevindingen passend bij verkregen afwijking.
Exclusion criteria
age below 18 years
serious language or communication barrier
pacemaker (with respect to MRI)
familial chromosomal, syndromal or metabolic abnormality
confirmed chromosomal abnormality
suspected syndromal or metabolic abnormality
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL25476.000.10 |