Clinical trial NCT03902652: Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During CC+SI During CPR of Asphyxiated Newborns Improve Time to ROSC
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart; Arrest, Newborn
Birth Asphyxia
Bradycardia Neonatal
Keywords: Chest Compression
Newborn
Infant
Sustained Inflation
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Return of spontaneous Circulation
timeFrame: up to 60 Minutes of chest compression
Secondary outcomes:
measure: Mortality
timeFrame: Until infant is discharge from hospital (maximum of 30 weeks after birth)
measure: Number of Epinephrine dosses during resuscitation
timeFrame: During resuscitation (up to 60 minutes)
measure: Rate of brain injury
timeFrame: Until infant is discharge from hospital (maximum of 30 weeks after birth)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
Study officials:
affiliation: University of Alberta
name: Georg Schmolzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: