Cardiac Arrest
Conditions
Brief summary
Newborn infants who require cardiopulmonary resuscitation at birth receive chest compression using a 3-Compression to 1-Ventilation (3:1 C:V) ratio. However, the optimal chest compression technique during cardiopulmonary resuscitation is uncertain and identified as a critical gap in evidence. The International Consensus Statement advises to use the 3:1 C:V ratio based on animal studies, and states that there are no clinical trials to support this approach and called for more research. There continues to be uncertainty about the optimal chest compression technique during cardiopulmonary resuscitation. This trial will compare if in newborn infants with cardiac arrest in the delivery room does providing CC+SI (a new chest compression technique) compared to 3:1 C:V decreases the incidence of all mortality within the initial hospital stay. This will be a multi-centre international cluster randomized trial.
Interventions
PROCEDURECC+SI (Chest compression during sustained inflation)
CC+SI (Chest compression during sustained inflation)
PROCEDURE3:1 C:V (3:1 Compression:Ventilation ratio)
3:1 C:V Group (Control group - Standard of Care): Newborns randomized to "3:1 C:V" will receive a CC rate of 90/min and 30 ventilations/min as per current resuscitation guidelines. The PIP used for the 30 inflations will also be 30cmH2O) as per current resuscitation guidelines. Every 60sec, a HR assessment as per neonatal guidelines will be performed to assess if HR is \<60/min - continue CC or \>60/min - stop CC (current standard of care). 3:1 C:V will be continued until ROSC.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 40 Years
Healthy volunteers
No
Inclusion criteria
* Newborns with gestational age born between 28 to 43 weeks based on best available obstetrical estimate * Newborns designated to receive full resuscitation, i.e., parental request or pre-determined decision to provide only comfort care at birth * No known major congenital or chromosomal malformation. All newborns who meet inclusion criteria will be enrolled as the centres agreed to change their local hospital policy during the trial. The inclusion criteria are designed to be pragmatic and provide useful knowledge translation for most of the patient population in the future.
Exclusion criteria
\- Newborns born outside of study centers and transported to centers after delivery. Sex, race, and ethnicity are not part of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal mortality | 0-40 days after birth | All mortality within the initial hospital stay |
Countries
Canada
Contacts
CONTACTCaroline Fray
PRINCIPAL_INVESTIGATORGeorg Schmolzer
University of Alberta
Outcome results
None listed