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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02858583




Registration number
NCT02858583
Ethics application status
Date submitted
30/07/2016
Date registered
8/08/2016
Date last updated
1/08/2024

Titles & IDs
Public title
SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Scientific title
SURV1VE-Trial - Sustained Inflation and Chest Compression Versus 3:1 Chest Compression to Ventilation Ratio During Cardiopulmonary Resuscitation of Asphyxiated Newborns: A Randomized Controlled Trial
Secondary ID [1] 0 0
1.0
Universal Trial Number (UTN)
Trial acronym
SURV1VE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Arrest 0 0
Birth Asphyxia 0 0
Bradycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system
Cardiovascular 0 0 0 0
Coronary heart disease
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS-9674
Treatment: Surgery - CC+SI
Treatment: Surgery - 3:1 C:V

Experimental: Intervention (CC+SI) - Infants randomized into the "CC+SI group" will receive a SI with a PIP of 25-30 cmH2O while receiving chest compression. The SI will be delivered over a period of 45 seconds. This will be followed by PEEP of 5-8 cm water to perform an assessment of the newborn's heart rate. If heart rate is \>60/min continue with standard care as per local hospital policy (standard hospital practice guideline). If heart rate remains \<60/min continue with CC+SI for another 45sec at which time a further assessment should be performed. If heart rate remains \<60/min continue with CC+SI.

Active comparator: Control (3:1 C:V) - Infants randomized into the "3:1 C:V group" will receive CC at a rate of 90/min and 30 ventilations/min in a 3:1 C:V ratio as recommended by the current resuscitation guidelines.


Treatment: Drugs: GS-9674
Tablet administered orally once daily

Treatment: Surgery: CC+SI
chest compression will be delivered during sustained inflation (CC+SI). The duration of each sustain inflation is 20sec. After 20sec a pause of 1sec id done before the next sustained inflation is delivered for another 20sec. Chest compressions are given continuously. This approach is continued until return of spontaneous circulation.

Treatment: Surgery: 3:1 C:V
During 3:1 C:V. 3 chest compressions are given, then stopped and then 1 inflation is given. This approach is continued until return of spontaneous circulation.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Return of Spontaneous Circulation
Timepoint [1] 0 0
up to 60 Minutes of chest compression
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
Until infant is discharge from hospital (maximum of 30 weeks after birth)
Secondary outcome [2] 0 0
Rate of Brain Injury - Intraventricular Hemorrhage
Timepoint [2] 0 0
Until infant is discharge from hospital (maximum of 30 weeks after birth)
Secondary outcome [3] 0 0
Necrotizing Enterocolitis
Timepoint [3] 0 0
Until infant is discharge from hospital (maximum of 30 weeks after birth)

Eligibility
Key inclusion criteria
* Infants (term or preterm infants >28 weeks' gestation) requiring CC in the delivery room will be eligible for the trial.
Minimum age
0 Minutes
Maximum age
20 Minutes
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation (e.g. congenital diaphragmatic hernia), or congenital heart disease requiring intervention in the neonatal period. Infants would be also excluded if their parents refused to give consent to this study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2022
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Canada
State/province [3] 0 0
Edmonton
Country [4] 0 0
Canada
State/province [4] 0 0
Halifax

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Georg Schmolzer
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02858583