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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
NA trial testing Intervention (21% oxygen during CC+SI) in Heart; Arrest, Newborn. Withdrawn.
30 June 2027
Quick facts
| Lead sponsor | University of Alberta |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 27 August 2022 |
| Primary completion | 30 June 2027 |
| Estimated completion | 30 September 2027 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Intervention (21% oxygen during CC+SI)
- Intervention (100% oxygen during CC+SI)
Conditions studied
- Heart; Arrest, Newborn — all drugs for Heart; Arrest, Newborn →
- Birth Asphyxia — all drugs for Birth Asphyxia →
- Bradycardia Neonatal — all drugs for Bradycardia Neonatal →
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.
Verify or expand the search:
- PubMed search for NCT03902652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03902652 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Alberta
- Last refreshed: 26 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03902652.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing