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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

CC+SI (Chest compression during sustained inflation)
Procedure/Surgery
CC+SI (Chest compression during sustained inflation)
3:1 C:V (3:1 Compression:Ventilation ratio)
Procedure/Surgery
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.

Treatment groups

554 Participants

are divided into 2 treatment groups

Group A: CC+SI (Chest compression during sustained inflation)Experimental treatment 1 intervention

Group B: 3:1 C:V (3:1 Compression:Ventilation ratio)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Neonatal mortality

All mortality within the initial hospital stay

Time frame

0-40 days after birth

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: