Chest Compression Techniques for Cardiac Arrest in Newborns (SUR1VE-2 Trial)

N/A

Waitlist Available

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within the first 28 days after birth

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare a new chest compression technique called CC+SI to the standard 3-Compression to 1-Ventilation ratio in newborn infants with cardiac arrest. The goal is to see if

Who is the study for?

This trial is for newborn infants who experience cardiac arrest in the delivery room and require cardiopulmonary resuscitation. The eligibility criteria are not fully listed, but typically include specific health conditions of the infant.

What is being tested?

The study is testing two different techniques of chest compressions during cardiopulmonary resuscitation: CC+SI (Chest compression with sustained inflation) versus the standard 3:1 Compression to Ventilation ratio. It aims to determine which method better reduces mortality at hospital discharge.

What are the potential side effects?

As this trial involves critical emergency procedures on newborns, side effects are not detailed like typical drug trials. However, risks may include those associated with any form of cardiopulmonary resuscitation such as potential injury from compressions or complications from improper ventilation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby was born between 28 to 43 weeks of pregnancy.

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My newborn will receive all necessary life-saving measures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within the first 28 days after birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within the first 28 days after birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and within the first 28 days after birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neonatal mortality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CC+SI (Chest compression during sustained inflation)Experimental Treatment1 Intervention

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 II: 3:1 C:V (3:1 Compression:Ventilation ratio)Active Control1 Intervention

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.

0 / 2Eligibility criteria met