NCT06577818

Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 554 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 40 Minutes
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrest

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2031-07-01
• Completion: 2033-07-01
• First posted: 2024-08-29
• Last updated: 2025-08-06

Locations

1 site across 1 country: Canada