Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001298606p
Ethics application status
Submitted, not yet approved
Date submitted
13/11/2023
Date registered
13/12/2023
Date last updated
13/12/2023
Date data sharing statement initially provided
13/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing servo-controlled and cold pack methods for providing cooling treatment for newborns with perinatal asphyxia during transport
Scientific title
Efficiency of servo-controlled vs. cold pack delivered therapeutic hypothermia for newborns with hypoxic ischaemic encephalopathy (HIE) during neonatal transport: A randomised controlled trial
Secondary ID [1] 310951 0
None
Universal Trial Number (UTN)
Trial acronym
COOL COT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxic ischaemic encephalopathy 332029 0
Condition category
Condition code
Neurological 328758 328758 0 0
Other neurological disorders
Reproductive Health and Childbirth 328930 328930 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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,
Intervention code [1] 327378 0
Treatment: Devices
Comparator / control treatment
Use of the servo-controlled device (intervention) will be compared with the current standard treatment of cold packs (comparator).
Cold packs are stored in the NETS WA fridge (never frozen) and are applied to the baby depending on the internal temperature as per a treatment algorithm. They are placed into cotton bags so not to be in direct contact with the skin to avoid adverse skin reactions e.g cold burns. The baby’s temperature is monitored continuously via an in-dwelling rectal thermometer which is read ever 15-minutes. If rectal temperature falls < 33.0oC, the transport isolate warmer (on manual) is switched on and gradually adjusted to maintain rectal temp at 33.0-34.0oC. The heater is turned off once temperature reaches 33.5oC.
These cold packs will be applied by the NETS nurse or doctor at the referring hospital and this method of cooling will be continued for the duration of the transport process.
Adherence to the comparator treatment will be ensured by reviewing the patient's transport records.
Control group
Active

Outcomes
Primary outcome [1] 336561 0
Temperature within range 33-34 degrees Celcius on arrival at receiving hospital.
Timepoint [1] 336561 0
On arrival at receiving hospital
Secondary outcome [1] 428819 0
Time to target temperature (between 33 and 34 degrees C)
Timepoint [1] 428819 0
Measured every 15 minutes throughout the transport process.
Secondary outcome [2] 428828 0
Duration of time spent outside of target temperature range
Timepoint [2] 428828 0
Measurements will be taken every 15 minutes for the duration of the transport process
Secondary outcome [3] 428829 0
Degree of fluctuation in temperature
Timepoint [3] 428829 0
Temperature will be measured every 15 minutes throughout the transport process.
Secondary outcome [4] 428830 0
Safety outcomes. Adverse events from therapeutic hypothermia by the servo-controlled device during transport, e.g. related to temperature probe and cooling jacket (Curewrap)
Timepoint [4] 428830 0
For duration of intervention (during the transport)
Secondary outcome [5] 429487 0
Long term outcome: Comparison of MRI brain findings on days 5-10 (part of routine care)
Timepoint [5] 429487 0
At time of MRI on day 5-10 of life.
Secondary outcome [6] 429488 0
Long term outcome: Comparison of neurodevelopmental outcome using 2-year Bayley Scales of Infant and Toddler Development 4th Edition (BAYLEY-IV) follow up (part of routine care).
Timepoint [6] 429488 0
At 2 year review of participant

Eligibility
Key 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)
Minimum age
0 Hours
Maximum age
12 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be centralised and computer-generated
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2024
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25837 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 41665 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 315211 0
Charities/Societies/Foundations
Name [1] 315211 0
Perth Children's Hospital Foundation
Country [1] 315211 0
Australia
Primary sponsor type
Government body
Name
Child and Adolescent Health Service Executive
Address
CAHS, 15 Hospital Avenue, Nedlands, WA6009
Country
Australia
Secondary sponsor category [1] 317237 0
None
Name [1] 317237 0
Address [1] 317237 0
Country [1] 317237 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314136 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 314136 0
Ethics committee country [1] 314136 0
Australia
Date submitted for ethics approval [1] 314136 0
06/12/2023
Approval date [1] 314136 0
Ethics approval number [1] 314136 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130542 0
A/Prof Jonathan Davis
Address 130542 0
Newborn Emergency Transport Service, Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6009
Country 130542 0
Australia
Phone 130542 0
+61 0864565392
Fax 130542 0
Email 130542 0
[email protected]
Contact person for public queries
Name 130543 0
Jonathan Davis
Address 130543 0
Newborn Emergency Transport Service, Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6009
Country 130543 0
Australia
Phone 130543 0
+61 0864565392
Fax 130543 0
Email 130543 0
[email protected]
Contact person for scientific queries
Name 130544 0
Jonathan Davis
Address 130544 0
Newborn Emergency Transport Service, Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6009
Country 130544 0
Australia
Phone 130544 0
+61 0864565392
Fax 130544 0
Email 130544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20897Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.