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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Sudhin
Thayyil
s.thayyil@imperial.ac.uk
Josephine
Mendoza
j.mendoza@imperial.ac.uk
Other disorders originating in the perinatal period
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Approximately one million full term babies die and an equivalent number become disabled for life every year as a result of birth asphyxia related brain injury. Although cooling the body to 33.5°C for 72 hours benefits babies who have severe forms of brain injury, most babies have milder forms of brain injury (i.e. mild encephalopathy).
1. To examine the feasibility of recruiting and randomising babies with mild neonatal encephalopathy to multiple treatment durations.
2. To examine the feasibility of obtaining adequate quality data on the primary outcome for the phase II trial (i.e. thalamic N-acetyl aspartate level) in the recruited babies
3. To examine the feasibility of collecting adequate quality data for exploratory sub-studies on heart rate variability and gene expression profile
METHODS
A total of 32 babies with mild neonatal encephalopathy will be recruited from several large hospitals in the UK, and will be randomised to normothermia (36 to 36.5C) or whole-body cooling for one of three durations: 24h, 48h, or 72h followed by rewarming at 0.5C per hour. We will collect 0.5 ml of venous or arterial blood at the time of recruitment (aged < 6 hours) and again at 80 hours of age. All babies will have continuous ECG and aEEG recording as part of the intensive care for at-least 72 hours. The thalamic concentration of N-acetyl-aspartate, [NAA], will be measured using 3 Tesla magnetic resonance (MR) spectroscopy performed between 4 and 7 days after birth.
DATA ANALYSIS AND OUTCOME MEASURES
• Proportion of the eligible babies recruited and the realistic recruitment rates per centre
• Number of babies with adequate quality data on thalamic NAA levels.
This feasibility study will inform the design of a phase II RCT of cooling in mild encephalopathy.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Device;Imaging;Other;
You can take part if:
You may not be able to take part if:
The following group of babies will be excluded prior to randomisation 1. Babies without encephalopathy 2. Babies with moderate or severe encephalopathy who meet the current NICE/AAP guidelines for cooling therapy. 3. Babies with seizures (clinical and/or aEEG/EEG) 4. Babies with moderate or severe abnormalities on aEEG voltage criteria. 5. Babies with life threatening congenital malformations
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by NIHR Academy; GARFIELD WESTON FOUNDATION; .
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Read full details
for Trial ID: CPMS 37318
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