Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
ConditionCardiac Arrest
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 40
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- CC+SI (Chest compression during sustained inflation)
- 3:1 C:V (3:1 Compression:Ventilation ratio)
Treatment groups
554 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov