None listed
Conditions
Brief summary
All babies with a diagnosis of HIE who require retrieval for therapeutic hypothermia will be approached by NETS WA and randomised to either servo-controlled cooling or current standard care (cold packs). The primary outcome will be baby temperature in range (33.0 – 34.0 degrees Celcius) on arrival at the receiving unit. Secondary outcomes will look at time to achieving therapeutic temperature, duration of time spent out of range, degrees of temperature fluctuation and safety. We aim to recruit 52 babies in 18-months to assess feasibility, efficacy and safety.
Interventions
All babies with a diagnosis of hypoxic ischaemic encephalopathy (HIE) who require retrieval for therapeutic hypothermia will be approached by Newborn Emergency Transport Service Western Australia (NETS WA) and randomised to either servo-controlled cooling (intervention) or cold packs (comparator/current standard care).
Servo-controlled cooling involves the use of a device called CritiCool Mini (Belmont Medical Technologies, USA) with a specialised wrap (Curewrap) which circulates water at a des
All babies with a diagnosis of hypoxic ischaemic encephalopathy (HIE) who require retrieval for therapeutic hypothermia will be approached by Newborn Emergency Transport Service Western Australia (NETS WA) and randomised to either servo-controlled cooling (intervention) or cold packs (comparator/current standard care). Servo-controlled cooling involves the use of a device called CritiCool Mini (Belmont Medical Technologies, USA) with a specialised wrap (Curewrap) which circulates water at a desired temperature around the baby so that they remain within a target temperature. A rectal thermometer provides continuous feedback to the control unit and the temperature of the water is constantly adjusted to maintain a steady internal temperature. The temperature will be set at 33.5 oC in the targeted temperature management mode in the Criticool mini. The baby will be wrapped in the Curewrap for to allow the servo-controlled cooling. The Curewrap is a single use, one-piece, body-shaped, flexible garment that is easy to wrap and secure for the patient. A pressure relief algorithm periodically lets the water drain from the wrap, for slight repositioning of the patient, and specially designed channels within the garment distribute pressure. This wrap will be applied by the NETS nurse or doctor at the referring hospital and the intervention will be continued for the duration of the transport process. Adherence to the intervention treatment will be ensured by reviewing the patient's transport records,
Sponsors
Child and Adolescent Health Service Executive
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 12 Hours
Healthy volunteers
No
Inclusion criteria
Require transport for definitive therapeutic hypothermia At least 35 weeks gestation Informed parental consent. Evidence of HIE as defined by regional neonatal guideline a. Evidence of asphyxia as defined by the presence of at least two of the following four criteria: i. Any acute perinatal event that may result in HIE (e.g. abruption of placenta, cord prolapse, severe foetal heart-rate abnormality). ii. Apgar < 6 at 10 minutes or continued need for resuscitation with positive pressure ventilation +/- chest compressions at 10 minutes of age. iii. Cord pH < 7.0 or base deficit of 12 or more. iv. If cord pH is not available, pH < 7.0 or BE > 12 mmol/L within 60 minutes of birth on post-natal blood gas. b. Moderate or severe encephalopathy defined by at least one of the following 3 criteria i. >=3 criteria in moderate/severe category based on modified Sarnat Classification ii. Seizures iii. Abnormal amplitude-integrated electroencephalogram (aEEG) (low voltage discontinuous, burst suppression)
Exclusion criteria
Major congenital abnormality that will require urgent surgery within the first 72-hours of life gastrointestinal abnormality that a rectal probe can or should not be inserted. Active bleeding and coagulopathy in which cooling would likely exacerbate. Newborn who appears moribund in which ongoing treatment is likely to be futile. Refusal of consent
Outcome results
None listed