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SI + CC Versus 3:1 C:V Ratio During Neonatal CPR (SURV1VE)

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ClinicalTrials.gov Identifier: NCT02858583
Recruitment Status : Recruiting
First Posted : August 8, 2016
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE July 30, 2016
First Posted Date  ICMJE August 8, 2016
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE October 19, 2017
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
Return of spontaneous Circulation [ Time Frame: up to 60 Minutes of chest compression ]
Duration of chest compression heart rate is >60/min for 60sec.
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2016)
Return of spontaneous Circulation [ Time Frame: up to 60 Minutes of chest compression ]
Duration of chest compression heart rate is >60/min for 15sec.
Change History Complete list of historical versions of study NCT02858583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
  • Mortality [ Time Frame: Until infant is discharge from hospital (maximum of 30 weeks after birth) ]
    Number of infants who die until discharge - comparison between group
  • Number of Epinephrine dosses during resuscitation [ Time Frame: During resuscitation (up to 60 minutes) ]
    How many doses of epinephrine are given - comparison between group
  • Rate of brain injury [ Time Frame: Until infant is discharge from hospital (maximum of 30 weeks after birth) ]
    Brain injury either by ultrasound or magnet resonance imaging - comparison between group
  • Necrotizing enterocolitis [ Time Frame: Until infant is discharge from hospital (maximum of 30 weeks after birth) ]
    Number of infants who develop Necrotizing enterocolitis - comparison between group
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Official Title  ICMJE 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
Brief Summary

Research question In newborn infants requiring CPR, does CC superimposed by sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation?

Overall objective: CC superimposed by sustained inflation will improve short- and long-term outcomes in preterm (>28 weeks or older) and term newborns.

Hypothesis to be tested Primary hypothesis: By using CC superimposed by sustained inflation (CC+SI) during CPR the time needed to achieve return of spontaneous circulation (ROSC) compared to the current 3:1 compression to ventilation (C:V) will be reduced in asphyxiated newborns.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Arrest
  • Birth Asphyxia
  • Bradycardia
Intervention  ICMJE
  • Procedure: 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.
  • Procedure: 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: 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.
    Intervention: Procedure: 3:1 C:V
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 19, 2017)
218
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2016)
118
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants (term or preterm infants >28 weeks' gestation) requiring CC in the delivery room will be eligible for the trial.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 20 Minutes   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Georg Schmolzer +1 7807354647 georg.schmoelzer@me.com
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   China,   Germany,   Ireland,   Italy,   Norway,   Poland,   Qatar,   United Kingdom
Removed Location Countries Spain,   United States
 
Administrative Information
NCT Number  ICMJE NCT02858583
Other Study ID Numbers  ICMJE 1.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Georg Schmolzer University of Alberta
PRS Account University of Alberta
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP