Heart; Arrest, NewbornSURV1VE-O2NCT03902652
Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During CC+SI During CPR of Asphyxiated Newborns Improve Time to ROSC
A study testing Intervention (21% oxygen during CC+SI) and Intervention (100% oxygen during CC+SI) in people with Heart; Arrest, Newborn and Birth Asphyxia, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 0 to 20 minutes
- Conditions the study is for
- Heart; Arrest, Newborn, Birth Asphyxia, Bradycardia Neonatal
- What is being tested?
- Intervention (21% oxygen during CC+SI) and Intervention (100% oxygen during CC+SI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 27 Aug 2022to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 20 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term infants requiring chest compressions in the delivery room
- Preterm infants >28 weeks' gestation requiring chest compressions in the delivery room
Who cannot join
- Infants with congenital abnormality
- Infants with congenital diaphragmatic hernia or congenital heart disease
- Infants who's parents refused to give consent to this study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Heart; Arrest, Newborn, Birth Asphyxia, Bradycardia Neonatal
- Being tested
- Intervention (21% oxygen during CC+SI), Intervention (100% oxygen during CC+SI)
- Keywords
- Chest Compression, Newborn, Infant, Sustained Inflation
- Medical subject headings
- Heart Arrest, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention (21% oxygen during CC+SI)Procedure or surgery
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)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (21% oxygen during CC+SI) | Experimental | 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. Receives: Procedure: Intervention (21% oxygen during CC+SI) |
| Intervention (100% oxygen during CC+SI) | Active comparator | 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. Receives: Procedure: Intervention (100% oxygen during CC+SI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of spontaneous Circulation
Duration of chest compression heart rate is >60/min for 60sec.
Measured: up to 60 Minutes of chest compression
Secondary outcomes (3)
Mortality
Number of infants who die until discharge - comparison between group
Measured: 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
Measured: During resuscitation (up to 60 minutes)
Rate of brain injury
Brain injury either by ultrasound or magnet resonance imaging - comparison between group
Measured: Until infant is discharge from hospital (maximum of 30 weeks after birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start27 Aug 2022 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Why it stopped: Study never commenced at trial site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart; Arrest, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg Schmolzer, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902652
- Sponsor's protocol ID
- Pro00088541
- Acronym
- SURV1VE-O2
- Status last verified
- Jun 2022
- First submitted
- 2 Apr 2019
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03902652
- Acronym / sponsor ID
- SURV1VE-O2 / Pro00088541
- Conditions
- Heart; Arrest, Newborn, Birth Asphyxia, Bradycardia Neonatal
- Keywords
- Chest Compression, Newborn, Infant, Sustained Inflation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never commenced at trial site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 27 Aug 2022 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (21% oxygen during CC+SI) | Experimental | 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) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 0 to 20 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Term infants requiring chest compressions in the delivery room
- Preterm infants >28 weeks' gestation requiring chest compressions in the delivery room
Key exclusion criteria (3 listed)
- Infants with congenital abnormality
- Infants with congenital diaphragmatic hernia or congenital heart disease
- Infants who's parents refused to give consent to this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Intervention (21% oxygen during CC+SI) |
| 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. | Procedure or surgery | Intervention (100% oxygen during CC+SI) |
Primary outcome
Return of spontaneous Circulation
Time frame: up to 60 Minutes of chest compression
Duration of chest compression heart rate is >60/min for 60sec.
3 secondary outcomes
Mortality
Time frame: Until infant is discharge from hospital (maximum of 30 weeks after birth)
Number of Epinephrine dosses during resuscitation
Time frame: During resuscitation (up to 60 minutes)
Rate of brain injury
Time frame: Until infant is discharge from hospital (maximum of 30 weeks after birth)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Schmolzer, MD, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (21% oxygen during CC+SI) and Intervention (100% oxygen during CC+SI) in people with Heart; Arrest, Newborn and Birth Asphyxia, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of spontaneous Circulation (time frame: up to 60 Minutes of chest compression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.