Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000728639
Ethics application status
Approved
Date submitted
23/04/2014
Date registered
8/07/2014
Date last updated
8/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of the Optimal Cooling period for hypothermic treatment of Hypoxic Ischemic Encephalopathy (HIE) in term neonates (OCHIE)
Scientific title
A study which will analyse all available clinical parameters of term babies where the clinical decision has been to administer hypothermia treatment following a hypoxic event during cooling and re-warming to determine if there are clinical parameters which aids diagnosis of the severity of the hypoxic insult and outcome prediction and allows analysis and determination of the optimal cooling period based on the severity.
Secondary ID [1] 284476 0
Nil known
Universal Trial Number (UTN)
U1111-1155-9877
Trial acronym
OCHIE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxic Ischemic Encephalopathy 291718 0
Condition category
Condition code
Neurological 292095 292095 0 0
Other neurological disorders
Reproductive Health and Childbirth 292096 292096 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Additional measurements of the Resistance Index (RI) are measured with Ultrasound daily whilst cooled and every 0.5 degrees (C) increase in rectal temperature (approximately 2 hourly). After warmed, RI will be measured daily until recovery to normal (1 week maximum).
All available clinical parameters recorded and analysed including (but not limited to) vital signs, pathology results, and aEEG from time of consent until the return of the RI to normal (1 week maximum). Cerebral perfusion using Near-infrared Spectrometry (NIRS) continuously monitored from time of consent during cooling and re-warming and until RI returns to normal (again 1 week maximum).
Analysis of MRI (one MRI after re-warming).
Inclusion of 2 year developmental review.
Intervention code [1] 289240 0
Not applicable
Comparator / control treatment
Control group is normal term neonates that receive no treatment. Resistance index measured within 72 hours of birth.
Control group
Active

Outcomes
Primary outcome [1] 291970 0
aEEG activity - measured as the duration of abnormal activity as a percentage of time in relation to normal activity, and number and duration of seizures
Timepoint [1] 291970 0
0-4 days of age (before, during cooling and re-warming and immediately after treatment)
Primary outcome [2] 291971 0
Resistance Index (RI) as measured in the anterior and middle cerebral arteries significantly lower (more than one standard deviation) lower than in normal neonates
Timepoint [2] 291971 0
0-5 days of age (during and immediately following hypothermia treatment).
Secondary outcome [1] 307945 0
Severe disability as defined as motor and/or cognitive delay as determined by Paediatrician at 2 year developmental review.
Timepoint [1] 307945 0
2 years of age

Eligibility
Key inclusion criteria
Near-term or term infants born at 36 weeks' gestation or more with birth weight of >1.8kgs that have had hypothermia treatment started within 6 hours of birth because they have been clinically assessed and deemed suitable for the treatment because there was:
* Evidence of acute event around the time of birth Apgar
score of 5 or less at 10 minutes after birth, severe acidosis, defined as pH level of less than 7 or base deficit of 16 mmol/L or less (cord blood or any blood gas obtained within 1 h of birth), continued need for resuscitation at 10 minutes after birth and
* Evidence of moderate to severe encephalopathy at birth - clinically determined (at least 3 of the following:
lethargy, stupor, or coma; abnormal tone or posture; abnormal reflexes [suck, grasp, Moro, gag, stretch reflexes];
decreased or absent spontaneous activity; autonomic dysfunction [including bradycardia, abnormal pupils,
apneas]; and clinical evidence of seizures, moderately or severely abnormal amplitudeintegrated electroencephalography (aEEG) background or seizures (CoolCap and TOBY)
Minimum age
1 Hours
Maximum age
48 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 36 weeks gestation or hypothermia treatment not initiated within 6 hours of birth.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/01/2014
Actual
28/01/2014
Date of last participant enrolment
Anticipated
31/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2359 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 8022 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 289128 0
Hospital
Name [1] 289128 0
Mercy Hospital for Women
Country [1] 289128 0
Australia
Funding source category [2] 289556 0
University
Name [2] 289556 0
The University of Melbourne
Country [2] 289556 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
163 Studley Rd, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 287791 0
University
Name [1] 287791 0
The University of Melbourne
Address [1] 287791 0
1-100 Grattan Street, Parkville VIC 3010
Country [1] 287791 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290907 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 290907 0
163 Studley Rd, Heidelberg VIC 3084
Ethics committee country [1] 290907 0
Australia
Date submitted for ethics approval [1] 290907 0
Approval date [1] 290907 0
16/01/2014
Ethics approval number [1] 290907 0
R13/58

Summary
Brief summary
Babies who have deprived of oxygen during birth can be at risk of brain damage because the blood rushes to the
brain to compensate for the lack of oxygen. Cooling has been show to help prevent brain damage. Currently all
babies are cooled for 72 hours but it is thought that some babies may benefit from being cooled for longer. Babies
in this study will have more frequent ultrasound scans through the soft spot on the head (fontanelle) to monitor
blood flow to the brain. Ultrasound scans will occur before cooling, daily whilst cooled, and every hour during rewarming (this takes around 12 hours).
Whilst being treated the baby will be monitored by a patient monitor that monitors blood pressure, heart rate and
respiration rate and an electroencephalograph (EEG) monitor which records electrical brain activity. The data from
the patient monitor and EEG will be collected and analysed for the research. Pathology results and MRI’s may also be included in the research.
When the baby is 2, it is normal practice to invite parents of HIE babies to an interview with a Paediatrician to
discuss their developmental progress and this study will use the information from this developmental review.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 39 39 0 0
/AnzctrAttachments/366212-R13-58 Letter of Expedited Approval of new research.pdf
Attachments [2] 40 40 0 0
/AnzctrAttachments/366212-Final Ethics Approval - OCHIE.pdf

Contacts
Principal investigator
Name 47906 0
Ms Danielle Forster
Address 47906 0
c/- Department of Paediatrics
Mercy Hospital for Women
163 Studley Rd
Heidelberg
VIC 3084
Country 47906 0
Australia
Phone 47906 0
+61 449 989 471
Fax 47906 0
Email 47906 0
[email protected]
Contact person for public queries
Name 47907 0
Ms Carole Branch
Address 47907 0
Administrative Officer
Mercy Health HREC
163 Studley Rd
Heidelberg
VIC 3084
Country 47907 0
Australia
Phone 47907 0
+61 3 8458 4808
Fax 47907 0
Email 47907 0
[email protected]
Contact person for scientific queries
Name 47908 0
Dr Emmanuel Koumoundouros
Address 47908 0
Department of Electrical Engineering
The University of Melbourne
1-100 Grattan Street
Parkville VIC 3010
Country 47908 0
Australia
Phone 47908 0
+61 3 8344 4467
Fax 47908 0
Email 47908 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.