Back to resultsChest Compression and Sustained Inflation
Primary Purpose
Newborn Infants Having Asystole or Bradycardia at Birth
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CC+SI
3:1 CPR
Sponsored by
About this trial
This is an interventional treatment trial for Newborn Infants Having Asystole or Bradycardia at Birth focused on measuring Chest compression, Delivery Room, NICU,
Eligibility Criteria
Inclusion Criteria:
Newborn infants with asystole Newborn infants with bradycardia
Exclusion Criteria:
-
Sites / Locations
- Royal Alexandra Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SI+CC
3:1 CPR
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time needed to achieve Return of Spontaneous Circulation
We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique
Secondary Outcome Measures
Full Information
NCT ID
NCT02083705
First Posted
January 13, 2014
Last Updated
January 6, 2017
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT02083705
Brief Title
Chest Compression and Sustained Inflation
Official Title
Chest Compression and Sustained Inflation for Asystole or Bradycardia in Newborn Infants
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn Infants Having Asystole or Bradycardia at Birth
Keywords
Chest compression, Delivery Room, NICU,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SI+CC
Arm Type
Experimental
Arm Description
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.
Arm Title
3:1 CPR
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
CC+SI
Intervention Description
Chest compression will be superimposed by sustained inflation during CPR
Intervention Type
Procedure
Intervention Name(s)
3:1 CPR
Intervention Description
CPR using 3:1 ratio (control group)
Primary Outcome Measure Information:
Title
Time needed to achieve Return of Spontaneous Circulation
Description
We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique
Time Frame
within the first 10 minutes after birth
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newborn infants with asystole Newborn infants with bradycardia
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Schmolzer
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28988159
Citation
Schmolzer GM, O Reilly M, Fray C, van Os S, Cheung PY. Chest compression during sustained inflation versus 3:1 chest compression:ventilation ratio during neonatal cardiopulmonary resuscitation: a randomised feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F455-F460. doi: 10.1136/archdischild-2017-313037. Epub 2017 Oct 7.
Results Reference
derived
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Chest Compression and Sustained Inflation
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