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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 : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.


Condition or disease Intervention/treatment Phase
Heart Arrest Birth Asphyxia Bradycardia Procedure: CC+SI Procedure: 3:1 C:V Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.




Primary Outcome Measures :
  1. Return of spontaneous Circulation [ Time Frame: up to 60 Minutes of chest compression ]
    Duration of chest compression heart rate is >60/min for 60sec.


Secondary Outcome Measures :
  1. 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

  2. Number of Epinephrine dosses during resuscitation [ Time Frame: During resuscitation (up to 60 minutes) ]
    How many doses of epinephrine are given - comparison between group

  3. 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

  4. 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



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Ages Eligible for Study:   up to 20 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Georg Schmolzer +1 7807354647 georg.schmoelzer@me.com

Locations
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United States, Arizona
University of Arizona and Banner Medical Center Not yet recruiting
Tucson, Arizona, United States, 85724-5073
Contact: Ranjit Kylathu         
Principal Investigator: Ranjit Kylathu         
United States, California
Mary Birch Hospital Not yet recruiting
San Diego, California, United States, 92123
Contact: Anup Katheria         
Principal Investigator: Anup Katheria         
Australia
Royal Womens Hospital Not yet recruiting
Melbourne, Australia
Contact: Peter Davis         
Principal Investigator: Omar Kamlin         
Sub-Investigator: Peter Davis         
King Edward Memorial Hospital for Women Not yet recruiting
Perth, Australia
Contact: Andrew Gill         
Principal Investigator: Andrew Gill         
Austria
Landeskrankenhaus Feldkirch Not yet recruiting
Feldkirch, Austria
Contact: Burkart Simma         
Principal Investigator: Burkart Simma         
Medical University Graz Not yet recruiting
Graz, Austria
Contact: Gerhard Pichler         
Principal Investigator: Gerhard Pichler         
Medical University Vienna Not yet recruiting
Vienna, Austria
Contact: Michael Wagner         
Principal Investigator: Monika Olischar         
Sub-Investigator: Michael Wagner         
Canada
Royal Alexandra Hospital Recruiting
Edmonton, Canada
Contact: Georg Schmolzer    7807354660    georg.schmoelzer@me.com   
Principal Investigator: Georg Schmolzer         
Sub-Investigator: Po-Yin Cheung         
Sub-Investigator: Sylvia van Os         
IWK Health Centre Not yet recruiting
Halifax, Canada
Contact: Souvik Mitra         
Principal Investigator: Souvik Mitra         
McMaster Children's Hospital Not yet recruiting
Hamilton, Canada
Contact: Salhab el Helou         
Principal Investigator: Salhab el Helou         
CHU Sainte-Justine Not yet recruiting
Montreal, Canada
Contact: Ahmed Moussa         
Principal Investigator: Ahmed Moussa         
BC Children's Hospital Not yet recruiting
Vancouver, Canada
Contact: Deepak Manhas         
Principal Investigator: Deepak Manhas         
China
Hong Kong University Not yet recruiting
Shenzhen, China
Contact: Chun-Bong Chow         
Principal Investigator: Chun-Bong Chow         
Germany
University Hospital Ulm Not yet recruiting
Ulm, Germany
Contact: Helmut Hummler         
Principal Investigator: Helmut Hummler         
Ireland
University College Cork Not yet recruiting
Cork, Ireland
Contact: Eugene Dempsey         
Principal Investigator: Eugene Dempsey         
Italy
Ospedale dei Bambini Vittore Buzzi Not yet recruiting
Milano, Italy
Contact: Gianluca Lista         
Sub-Investigator: Francesco Cavigioli         
Sub-Investigator: Francesca Castoldi         
Principal Investigator: Gianluca Lista         
Norway
Akershus University Hospital Not yet recruiting
Oslo, Norway
Contact: Anne Solevåg         
Sub-Investigator: Brit Nakstad         
Principal Investigator: Anne Solevåg         
Poland
Poznan University of Medical Sciences Not yet recruiting
Poznań, Poland
Contact: Jan Mazela         
Principal Investigator: Jan Mazela         
Qatar
Division of Neonatology Department of Pediatrics, Sidra Medicine Not yet recruiting
Doha, Qatar
Contact: Helmut Hummler         
Sub-Investigator: Nicola Robertson         
Principal Investigator: Helmut Hummler         
Spain
University & Polytechnic Hospital La Fe Not yet recruiting
Valencia, Spain
Contact: Max Vento         
Principal Investigator: Max Vento         
United Kingdom
John Radcliffe Hospital Not yet recruiting
Oxford, United Kingdom
Contact: Charles-Christoph Roehr         
Principal Investigator: Charles-Christoph Roehr         
Great Western Hospitals NHS Foundation Trust Not yet recruiting
Swindon,, United Kingdom
Contact: Sarah Bates         
Principal Investigator: Sarah Bates         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Georg Schmolzer University of Alberta

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02858583     History of Changes
Other Study ID Numbers: 1.0
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Chest Compression
Newborn
Infant
Sustained Inflation
Additional relevant MeSH terms:
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Bradycardia
Heart Arrest
Asphyxia Neonatorum
Asphyxia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death
Wounds and Injuries
Infant, Newborn, Diseases