Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CC+SI (Chest compression during sustained inflation), 3:1 C:V (3:1 Compression:Ventilation ratio).
- Who it may be relevant to
- Registry conditions: Cardiac Arrest. Basic parameters: up to 40 Minutes · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sustained Inflation and Chest Compression Versus 3:1 Chest Compression to Ventilation Ratio During Cardiopulmonary Resuscitation of Asphyxiated Newborns - a Multi-centre, International Cluster Randomized Control Trial
Overview
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
- Procedure CC+SI (Chest compression during sustained inflation)
CC+SI (Chest compression during sustained inflation) - Procedure 3:1 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.
Primary outcome measures
- Neonatal mortality [Time frame: 0-40 days after birth]
Eligibility criteria
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 exclusion criteria for this trial, and as such it should represent the combined demographics of all centers involved.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Royal Alexandra Hospital — Edmonton
Identifiers
NCT: NCT06577818 · Pro00145624