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

Study Overview
=================
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.

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

Conditions
-----------------
Heart; Arrest, Newborn, Birth Asphyxia, Bradycardia Neonatal

Intervention / Treatment
-----------------
* Procedure: Intervention (21% oxygen during CC+SI)
* Procedure: Intervention (100% oxygen during CC+SI)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Minutes
Maximum Age: 20 Minutes

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (21% oxygen during CC+SI)<br>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)<br>* 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.<br>|
| Active Comparator: Intervention (100% oxygen during CC+SI)<br>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)<br>* 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.<br>|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chest Compression, Newborn, Infant, Sustained Inflation