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NCT03902652: SURV1VE-O2

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

Withdrawn NA Last updated 26 September 2022
What this trial tests

NA trial testing Intervention (21% oxygen during CC+SI) in Heart; Arrest, Newborn. Withdrawn.

Timeline
27 August 2022
Primary endpoint
30 June 2027
30 September 2027

Quick facts

Lead sponsorUniversity of Alberta
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Start date27 August 2022
Primary completion30 June 2027
Estimated completion30 September 2027
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Alberta

Who can join

Adults 0 Minutes to 20 Minutes, any sex, with Heart; Arrest, Newborn or Birth Asphyxia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University of Alberta trials

Trials by the same sponsor.

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