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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bradycardia Neonatal; Birth Asphyxia; Heart; Arrest, Newborn
• Intervention / Treatment: Procedure: Intervention (21% oxygen during CC+SI); Procedure: Intervention (100% oxygen during CC+SI)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Edmonton, Canada
    • Royal Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 20 minutes (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (21% oxygen during CC+SI); 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.	Procedure: Intervention (21% oxygen during CC+SI); 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.
Active Comparator: Intervention (100% oxygen during CC+SI); 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.	Procedure: Intervention (100% oxygen during CC+SI); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of spontaneous Circulation	Duration of chest compression heart rate is >60/min for 60sec.	up to 60 Minutes of chest compression

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of infants who die until discharge - comparison between group	Until infant is discharge from hospital (maximum of 30 weeks after birth)
Number of Epinephrine dosses during resuscitation	How many doses of epinephrine are given - comparison between group	During resuscitation (up to 60 minutes)
Rate of brain injury	Brain injury either by ultrasound or magnet resonance imaging - comparison between group	Until infant is discharge from hospital (maximum of 30 weeks after birth)

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Anticipated): August 27, 2022
• Primary Completion (Anticipated): June 30, 2027
• Study Completion (Anticipated): September 30, 2027

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Infant; Newborn; Chest Compression; Sustained Inflation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Arrhythmias, Cardiac; Death; Bradycardia; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: Pro00088541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: after publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No