The primary aim of this study is to investigate the safety and feasibility of ultra-high field magnetic resonance imaging (MRI) of the brain in neonates and to optimize scan protocols.
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Congenital and peripartum neurological conditions
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints of this study are safety, based on the measurement of
comfort, feeding intolerance, temperature and vital parameters of the infant,
specific absorption rate and sound pressure levels, and the feasibility based
on quality of the scan i.e. signal to noise ratio, contrast to noise,
B0-inhomogenieties.
Secondary outcome
not applicable
Background summary
A large part of the infants admitted to the neonatal intensive care unit will
experience long-term damage of different organ systems such as the lungs,
kidneys and intestines. However, one of the most important consequences on the
long term is injury to the developing brain and subsequent poor
neurodevelopmental outcome. In our department, all infants who are at risk for
brain damage are scanned using MRI to assess brain injury and to predict long
term neurodevelopmental outcome. Currently, we use a magnetic field of 3.0Tesla
(3.0T), however, for adults the current state of the art is 7.0Tesla (7.0T)
MRI, which has shown added value in a growing number of clinical studies. Using
7.0T MRI, it has been shown in adults that micro bleedings and micro-ischemic
lesions were better visible, but also the quality of imaging of the white
matter tracts, vascularization and magnetic resonance spectroscopy improved.
Since it is important for the future of the infant to visualize brain injury
early in order to predict outcome and to start early intervention, we expect
7.0T to offer a major improvement in neonatal health care. However, 7.0T MRI
has never been performed in infants and a first important step in this research
field would be a pilot study to assess safety.
Study objective
The primary aim of this study is to investigate the safety and feasibility of
ultra-high field magnetic resonance imaging (MRI) of the brain in neonates and
to optimize scan protocols.
Study design
In this observational study, we will investigate the feasibility and safety of
7.0T MRI in 20 infants between the term (equivalent) age (37 weeks gestational
age or more) and 3-months post-term. The clinically stable infants will undergo
a 7.0T MRI after their routine 3.0T MRI scan on the same to be able to compare
both scans. Infants will receive a sedative agent (current standard) before the
first (3.0T) MRI according to the clinical protocol. The MRI will be supervised
by a neonatologist and a 7.0T imaging expert will be present throughout the
second (7.0T) MR examination. Safety will be determined by measuring the
infant*s vital parameters, temperature, feeding intolerance and comfort scores
before, during and after MRI, as well as the specific absorption rate of the MR
scan. Since this is the first time 7.0T MRI will be performed in neonates and
to be able to adapt the MRI protocol to the unique properties of the neonatal
brain, the 7.0T scan protocols will be developed and optimized whilst scanning
the first patients. We will also compare the quality of the scan i.e. signal to
noise ratio, contrast to noise, B0-inhomogenieties of the 7.0T compared to the
3.0T MRI.
Study burden and risks
We expect this study to be beneficial to future patients if we find that 7.0T
MRI is a safe and feasible technique in neonates. It is expected to offer a
more accurate technique to assess the development of the brain on a
microstructural level. Furthermore, we think that the extent of (subtle) brain
injury can be better visualized, leading to a better prediction of outcome in
neonates. This is of importance to provide parents adequate information about
the future perspectives of their child, but also allows us in the near future
to select the right patients for neuroprotective therapies and to measure the
effect of neuroprotective therapies in more detail. Safety and feasibility of
7.0T MRI of the brain in neonates can also provide valuable information for
future studies of 7.0T imaging of other organs.
Since the anatomy, water content, damage and development of the brain in
neonates are not comparable with adults or older children, this study can only
be performed in neonates.
The burden for the infants will be the performance of 2 MRI scans instead of 1
MRI scan. Infants will receive an extra feeding via the nasal tube between the
two MRI scans, but will not receive a second dose of chloral hydrate to limit
the burden. Possible risks of the 7.0T MRI are an MRI related increase in
temperature, peripheral nerve stimulation and discomfort.
We will monitor the infant closely to minimalize the chance of adverse effects
and to be able to stop the MRI as soon as there is any evidence of adverse
effects or discomfort. Furthermore, there are technical challenges such as an
increased risk of artefacts.
Lundlaan 6
Utrecht 3584 EA
NL
Lundlaan 6
Utrecht 3584 EA
NL
Listed location countries
Age
Inclusion criteria
- Neonates with a clinical indication for MRI in the Wilhelmina Children*s
Hospital i.e. stroke, perinatal asphyxia, premature infants between term
equivalent age (37 weeks or more) and 3 months post-term;
Exclusion criteria
- Corpus alienum inside or outside the body that cannot be temporarily removed
i.e. ferrometal, pacemakers, cochlear implants, hydrocephalus pump, aneurysm
clips;
- Instable clinical condition e.g. respiratory support / intravenous or
intra-arterial catheters.
- Very irritable or feeding intolerance
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 | NL66198.041.18 |