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Chest Compression and Sustained Inflation

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02083705
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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Brief Summary:
Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.

Condition or disease Intervention/treatment Phase
Newborn Infants Having Asystole or Bradycardia at Birth Procedure: CC+SI Procedure: 3:1 CPR Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chest Compression and Sustained Inflation for Asystole or Bradycardia in Newborn Infants
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SI+CC

Chest compression will be superimposed by sustained inflations during CPR:

"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.

 Procedure: CC+SI
Chest compression will be superimposed by sustained inflation during CPR
Active Comparator: 3:1 CPR

CPR using 3:1 C:V ratio:

"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.

 Procedure: 3:1 CPR
CPR using 3:1 ratio (control group)


Outcome Measures
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Primary Outcome Measures :
  1. Time needed to achieve Return of Spontaneous Circulation [ Time Frame: within the first 10 minutes after birth ]
    We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique


Eligibility Criteria
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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Newborn infants with asystole Newborn infants with bradycardia

Exclusion Criteria:

-

Contacts and Locations
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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): NCT02083705


Locations
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Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Georg Schmolzer University of Alberta
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02083705    
Other Study ID Numbers: Pro00034524_CC
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Keywords provided by University of Alberta:
Chest compression, Delivery Room, NICU,
Additional relevant MeSH terms:
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Bradycardia
Heart Arrest
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes