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Intervention (CC+SI) for Slow Heart Rate (SURV1VE Trial)

N/A

Waitlist Available

Led By Georg Schmolzer

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Infants (term or preterm infants >28 weeks' gestation) requiring CC in the delivery room will be eligible for the trial.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 minutes of chest compression

Awards & highlights

SURV1VE Trial Summary

This trial will compare CC+SI to 3:1 compression to ventilation (C:V) in newborns requiring CPR. The goal is to see if CC+SI improves return of spontaneous circulation (ROSC).

Eligible Conditions

Slow Heart Rate
Cardiac Arrest
Neonatal Asphyxia

SURV1VE Trial Eligibility Criteria

Inclusion Criteria

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

SURV1VE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 minutes of chest compression

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 minutes of chest compression

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 minutes of chest compression for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Return of spontaneous Circulation

Secondary outcome measures

Mortality

Necrotizing Enterocolitis

Number of Epinephrine dosses during resuscitation

+1 more

SURV1VE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention (CC+SI)Experimental Treatment1 Intervention

Infants randomized into the "CC+SI group" will receive a SI with a PIP of 25-30 cmH2O while receiving chest compression. The SI will be delivered over a period of 45 seconds. This will be followed by PEEP of 5-8 cm water to perform an assessment of the newborn's heart rate. If heart rate is >60/min continue with standard care as per local hospital policy (standard hospital practice guideline). If heart rate remains <60/min continue with CC+SI for another 45sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI.

Group II: Control (3:1 C:V)Active Control1 Intervention

Infants randomized into the "3:1 C:V group" will receive CC at a rate of 90/min and 30 ventilations/min in a 3:1 C:V ratio as recommended by the current resuscitation guidelines.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC+SI

2017

N/A

~40

0 / 1Eligibility criteria met