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

NCT ID: NCT06577818

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 554 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2033-07-01

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 all mortality within the initial hospital stay.

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

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CC+SI (Chest compression during sustained inflation)

Intervention Type: PROCEDURE

CC+SI (Chest compression during sustained inflation)

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.

Group Type: ACTIVE_COMPARATOR

3:1 C:V (3:1 Compression:Ventilation ratio)

Intervention Type: PROCEDURE

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.

Interventions

CC+SI (Chest compression during sustained inflation)

CC+SI (Chest compression during sustained inflation)

Intervention Type: 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.

Intervention Type: PROCEDURE

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

Exclusion Criteria

• Newborns born outside of study centers and transported to centers after delivery.

• Maximum Eligible Age: 40 Minutes
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georg Schmolzer

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Royal Alexandra Hospital

Edmonton, , Canada

Countries

Canada

Central Contacts

Caroline Fray

Role: CONTACT

caroline.fray@albertahealthservices.ca

+1 (780) 613-5237‬

Other Identifiers

Pro00145624

Identifier Type: -

Identifier Source: org_study_id