An interventional study of Intervention (21% oxygen during CC+SI) and Intervention (100% oxygen during CC+SI) in Heart; Arrest, Newborn, Birth Asphyxia and Bradycardia Neonatal, sponsored by University of Alberta. Withdrawn at 1 site in Canada. Open to participants aged 0 Minutes to 20 Minutes. Per ClinicalTrials.gov, last updated 2022-09-26.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
Among 65 studies in Heart Arrest with a site in Canada — 10 open to participants now, 13 under way, 1 of them phase 3. Heart Arrest · Canada.
Among the 65 studies in Heart Arrest with a site in Canada, this one is the 45th largest by enrollment of the 46 interventional ones that give a count, is one of 2 that started in 2022, is one of 34 with no phase, and was the 47th registered.
926 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.
Browse Heart Arrest studies →10 of the 65 studies in Heart Arrest with a site in Canada are open now. Recruiting first, the newest first:
Columbia University · Sites in Canada, United States, Brazil and 2 more countries
Ages 18+
Laval University · Sites in Canada
University of Calgary · Sites in Canada
Johns Hopkins University · Sites in Canada, United States
Ages 18+ · Healthy volunteers
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Sites in Canada
Ages 1 days–17 yrs
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 157 Heart Arrest studies recruiting now, 109 (69%) set no upper age limit and 28 (18%) stop at 75 or younger; 30 take children under 18; 18 take healthy volunteers.
This study: 0 Minutes to 20 Minutes · all sexes · no healthy volunteers.
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65 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 5 · Phase 3 5 · Phase 4 1
First in 1992; this study’s year is marked. 2 started in 2022.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 246 across the 46 interventional studies, 793 across the 19 observational. Of the 44 that completed or were terminated, 20 (45%) have results posted.
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1 of 65 have an industry lead sponsor. The 10 most frequent:
University of Alberta is the lead sponsor of 824 studies on the registry; 170 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
University of Alberta has 6 studies filed under Heart Arrest — fewer than ten, so there is no comparison to draw.
2 of the studies in Heart Arrest with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07829887University of CalgaryCerebral Oximetry in Management of Post Cardiac Arrest | 2027-02 |
| NCT07484828Laval UniversityEvaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm | 2027-06 |
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Among the 65 studies in Heart Arrest with a site in Canada, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 "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 "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.
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.
Return of spontaneous Circulation
Duration of chest compression heart rate is \>60/min for 60sec.
Time frame: up to 60 Minutes of chest compression
Mortality
Number of infants who die until discharge - comparison between group
Time frame: 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
Time frame: During resuscitation (up to 60 minutes)
Rate of brain injury
Brain injury either by ultrasound or magnet resonance imaging - comparison between group
Time frame: Until infant is discharge from hospital (maximum of 30 weeks after birth)
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: after publication
No publications or documents are linked to this record.
Start is estimated for Aug 2022; primary completion for Jun 2027, 58 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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