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Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During CC+SI During CPR of Asphyxiated Newborns Improve Time to ROSC (SURV1VE-O2)

Primary Purpose

Heart; Arrest, Newborn, Birth Asphyxia, Bradycardia Neonatal

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intervention (21% oxygen during CC+SI)
Intervention (100% oxygen during CC+SI)
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart; Arrest, Newborn focused on measuring Chest Compression, Newborn, Infant, Sustained Inflation

Eligibility Criteria

0 Minutes - 20 Minutes (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Term infants requiring chest compressions in the delivery room
  • Preterm infants >28 weeks' gestation requiring chest compressions in the delivery room

Exclusion Criteria:

  • Infants with congenital abnormality
  • Infants with congenital diaphragmatic hernia or congenital heart disease
  • Infants who's parents refused to give consent to this study

Sites / Locations

  • Royal Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention (21% oxygen during CC+SI)

Intervention (100% oxygen during CC+SI)

Arm Description

Infants randomized into the "21% oxygen 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 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will 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 20sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI. During CC+SI the clinical team will only use 21% oxygen.

Infants randomized into the "100% oxygen 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 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will 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 20sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI. During CC+SI the clinical team will only use 100% oxygen.

Outcomes

Primary Outcome Measures

Return of spontaneous Circulation
Duration of chest compression heart rate is >60/min for 60sec.

Secondary Outcome Measures

Mortality
Number of infants who die until discharge - comparison between group
Number of Epinephrine dosses during resuscitation
How many doses of epinephrine are given - comparison between group
Rate of brain injury
Brain injury either by ultrasound or magnet resonance imaging - comparison between group

Full Information

First Posted
April 2, 2019
Last Updated
September 22, 2022
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03902652
Brief Title
Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During CC+SI During CPR of Asphyxiated Newborns Improve Time to ROSC
Acronym
SURV1VE-O2
Official Title
Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During Sustained Inflation and Chest Compression During Cardiopulmonary Resuscitation of Asphyxiated Newborns Improve Time to Return of Spontaneous Circulation - a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study never commenced at trial site.
Study Start Date
August 27, 2022 (Anticipated)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
When newborn babies are born without a heartbeat the clinical team has to provide breathing and chest compressions (what is call cardiopulmonary resuscitation) to the newborn baby. Cardiopulmonary resuscitation is an infrequent event in newborn babies (~1% of all deliveries), approximately one million newborn babies die annually due to lack of oxygen at birth causing being born without a heartbeat. Outcome studies of newborn babies receiving cardiopulmonary resuscitation in the delivery room have reported high rates of death and neurological impairment. This puts a heavy burden on health resources since these infants require frequent hospital re-admission and long-term care. The poor prognosis raises questions as improve cardiopulmonary resuscitation methods and specifically adapt them to newborn babies to improve outcomes. Currently a 3:1 ratio, which equals 3 chest compressions to one rescue breath to resuscitate a newborn baby. This means that chest compressions are stopped after every 3rd compression to give one rescue breath. The investigators believe that this interruption of chest compressions is bad for the newborn baby and that chest compressions should be continued without interruption while rescue breaths are given continuously. The investigators believe that this approach will allow us to reduce death and long-term burdens in newborn babies born without a heartbeat. Furthermore, it is not known if rescue breaths given with 100% oxygen or 21% oxygen (room air) is better for newborn babies. Using continuous chest compressions and rescue breaths without interruptions, this study will compare 21% with 100% oxygen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart; Arrest, Newborn, Birth Asphyxia, Bradycardia Neonatal
Keywords
Chest Compression, Newborn, Infant, Sustained Inflation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention (21% oxygen during CC+SI)
Arm Type
Experimental
Arm Description
Infants randomized into the "21% oxygen 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 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will 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 20sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI. During CC+SI the clinical team will only use 21% oxygen.
Arm Title
Intervention (100% oxygen during CC+SI)
Arm Type
Active Comparator
Arm Description
Infants randomized into the "100% oxygen 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 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will 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 20sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI. During CC+SI the clinical team will only use 100% oxygen.
Intervention Type
Procedure
Intervention Name(s)
Intervention (21% oxygen during CC+SI)
Intervention Description
Infants randomized into the "21% oxygen 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 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will 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 20sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI. During CC+SI the clinical team will only use 21% oxygen.
Intervention Type
Procedure
Intervention Name(s)
Intervention (100% oxygen during CC+SI)
Intervention Description
Infants randomized into the "100% oxygen 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 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will 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 20sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI. During CC+SI the clinical team will only use 100% oxygen.
Primary Outcome Measure Information:
Title
Return of spontaneous Circulation
Description
Duration of chest compression heart rate is >60/min for 60sec.
Time Frame
up to 60 Minutes of chest compression
Secondary Outcome Measure Information:
Title
Mortality
Description
Number of infants who die until discharge - comparison between group
Time Frame
Until infant is discharge from hospital (maximum of 30 weeks after birth)
Title
Number of Epinephrine dosses during resuscitation
Description
How many doses of epinephrine are given - comparison between group
Time Frame
During resuscitation (up to 60 minutes)
Title
Rate of brain injury
Description
Brain injury either by ultrasound or magnet resonance imaging - comparison between group
Time Frame
Until infant is discharge from hospital (maximum of 30 weeks after birth)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Minutes
Maximum Age & Unit of Time
20 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Term infants requiring chest compressions in the delivery room Preterm infants >28 weeks' gestation requiring chest compressions in the delivery room Exclusion Criteria: Infants with congenital abnormality Infants with congenital diaphragmatic hernia or congenital heart disease Infants who's parents refused to give consent to this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Schmolzer, MD, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
after publication

Learn more about this trial

Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During CC+SI During CPR of Asphyxiated Newborns Improve Time to ROSC

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