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

Not Applicable

Not yet recruiting

• Conditions: Cardiac Arrest
• Interventions: Procedure: CC+SI (Chest compression during sustained inflation)

• Registration Number: NCT06577818
• Lead Sponsor: University of Alberta

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 mortality at hospital discharge.

This will be a multi-centre international cluster randomized trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Study Start: 2025-07-01
• Primary Completion: 2030-07-01
• Study Completion: 2033-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

i) Newborns with gestational age born between 28 to 43 weeks based on best available obstetrical estimate; ii) Newborns designated to receive full resuscitation, i.e., parental request or pre-determined decision to provide only comfort care at birth; iii) 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

i) 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CC+SI (Chest compression during sustained inflation)	CC+SI (Chest compression during sustained inflation)	CC+SI Group (Intervention group): Newborns randomized to "CC+SI" will receive CPR with a SI using a peak inflation pressure (PIP) of 30cmH2O while receiving CC. The PIP was chosen based on our animal studies and two previous clinical trials. CC will be performed at a rate of minimum 90/min. Each SI will be delivered for duration of 30sec with a 1 sec pause between the next SI for 30sec is started while CCs are continued. After 2x30sec CC+SI (total of 60sec), Heart rate (HR) will be assessed: A HR \<60/min means CC+SI is continued for another 60sec (2x30sec CC+SI), followed by another HR assessment. If HR \>60/min, CC are stopped (current standard of care). CC+SI will continued until ROSC.

Primary Outcome Measures

Name	Time	Method
Neonatal mortality	0-40 days after birth	Death which occurs until first discharge from Hospital

Trial Locations

Locations (1)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Canada