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 : June 13, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Arrest Birth Asphyxia Bradycardia||Procedure: CC+SI Procedure: 3:1 C:V||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official 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|
|Actual Study Start Date :||October 19, 2017|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||August 2023|
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.
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.
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.
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.
- Return of spontaneous Circulation [ Time Frame: up to 60 Minutes of chest compression ]Duration of chest compression heart rate is >60/min for 60sec.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858583
|Contact: Georg Schmolzer||+1 email@example.com|
|Medical University Graz||Not yet recruiting|
|Contact: Gerhard Pichler|
|Principal Investigator: Gerhard Pichler|
|Medical University Vienna||Not yet recruiting|
|Contact: Michael Wagner|
|Principal Investigator: Monika Olischar|
|Sub-Investigator: Michael Wagner|
|Royal Alexandra Hospital||Recruiting|
|Contact: Georg Schmolzer 7807354660 firstname.lastname@example.org|
|Principal Investigator: Georg Schmolzer|
|Sub-Investigator: Po-Yin Cheung|
|Sub-Investigator: Sylvia van Os|
|IWK Health Centre||Not yet recruiting|
|Contact: Souvik Mitra|
|Principal Investigator: Souvik Mitra|
|Principal Investigator:||Georg Schmolzer||University of Alberta|