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

Birth Asphyxia Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03902652
• Other study ID #: Pro00088541
• Status: Withdrawn
• Phase: N/A
• Start date: August 27, 2022
• Est. completion date: September 30, 2027

Study information

• Verified date: June 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Minutes to 20 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia
• Bradycardia
• Bradycardia Neonatal
• Heart; Arrest, Newborn

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return of spontaneous Circulation	Duration of chest compression heart rate is >60/min for 60sec.	up to 60 Minutes of chest compression
Secondary	Mortality	Number of infants who die until discharge - comparison between group	Until infant is discharge from hospital (maximum of 30 weeks after birth)
Secondary	Number of Epinephrine dosses during resuscitation	How many doses of epinephrine are given - comparison between group	During resuscitation (up to 60 minutes)
Secondary	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)