To determine the feasibility of rs-fMRI in neonates undergoing a planned diagnostic MRI session following perinatal asphyxia. To assess intra-session reproducibility (test-retest reliability) of the rs-fMRI technique in neonates with asphyxia.
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
1.Feasibility of the rs-fMRI technique will be determined by assessing the
image quality of the dynamic scans, the presence of motion artefacts and the
temporal SNR.
2. The intra-session reproducibility of the rs-fMRI technique in neonates with
asphyxia determined by the mean and Standard Deviation (SD) of the difference
between 2 rs-fMRI acquisitions of 6 minutes each of the volume of the activated
set of voxels and of the signal intensity of these voxels. Bland-Altman plots
and Smallest Detectable Change will be used to report this.
Secondary outcome
nvt
Background summary
Hypoxic-ischemic encephalopathy (HIE) after perinatal asphyxia in neonates is a
serious condition that can cause long-term neurologic sequelae and in severe
cases even death. At this moment several clinical diagnostic tests are used to
evaluate the severity of the condition: EEG (electroencephalography), cerebral
ultrasound and conventional MRI (magnetic resonance imaging) with DWI
(diffusion-weighted imaging).
A relatively new possible functional test which needs to be evaluated is
resting state functional MRI (rs-fMRI). Rs-fMRI is a relatively new and
powerful method which is able to determine differences in patterns in regional
brain activity that occur when a subject is not performing an explicit task,
i.e. is in a *resting state*. These patterns are closely related to neural
subsystems revealed by task-activation fMRI. Because of the lack of task
demands, rs-fMRI is ideally suited for studying these endogenous low-frequency
fluctuations in neonates and identifies potential alterations in several
important brain networks, such as the visual and sensory/motor module.
Although rs-fMRI has proven to be useful in older children, its feasibility in
neonates with asphyxia still has to be determined. Also, as in any diagnostic
test, the reliability, reproducibility and validity of rs-fMRI has to be proven
before it is to be used as a diagnostic and prognostic instrument in clinical
practice.
Study objective
To determine the feasibility of rs-fMRI in neonates undergoing a planned
diagnostic MRI session following perinatal asphyxia.
To assess intra-session reproducibility (test-retest reliability) of the
rs-fMRI technique in neonates with asphyxia.
Study design
A mutlicenter center, cross-sectional study of 30 consecutive enrolled
neonates, GA (gestational age) * 36 weeks, diagnosed clinically with perinatal
asphyxia.
Study burden and risks
All scans will be performed for clinical diagnosis/ indications. No MR sessions
will be performed only for study purposes. The burden for patients is an
additional 12 minutes extra scan time in the MRI-scanner. MRI is a non-invasive
imaging modality and is considered to be a safe standard medical procedure. The
technique has no known complications. The risks associated with study
participation involving MRI scanning are negligible. The infants will be safely
embedded in blankets and receive hearing protection (earplugs and mini-muffs).
In the AMC we use a special MR-incubator (AMC) with monitoring of vital signs.
The incubator offers the possibility to investigate possible brain damage in
very fragile (even instable or ventilated) neonatal patients in an environment
controlled by neonatologists. All clinical data are available digitally for
each infant. Regular standard of care treatment will be given for all infants.
No experimental treatment will be prescribed. No additional laboratory
investigations will be performed. This study poses no risk for any of the
participants.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Term neonates clinically diagnosed with perinatal asphyxia.
Exclusion criteria
Lack of informed consent of parents (parental refusal or unable to explain because of language barrier).
Neonate with known congenital malformation(s) of the brain or congenital infection of the brain.
Neonate with known syndrome (e.g. Down syndrome).
Neonate with known congenital neuromuscular disease.
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 | NL42456.018.13 |