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Clinical Trials/NCT02083705
NCT02083705CompletedNot Applicable

Chest Compression and Sustained Inflation for Asystole or Bradycardia in Newborn Infants

University of Alberta1 site in 1 country9 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
9
Locations
1
Primary Endpoint
Time Needed to Achieve Return of Spontaneous Circulation

Study Overview

Brief Summary

Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
— to 3 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Newborn infants with asystole Newborn infants with bradycardia

Exclusion Criteria

  • Not provided

Arms & Interventions

3:1 CPR

Active Comparator

CPR using 3:1 C:V ratio:

"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.

Intervention: 3:1 CPR (Procedure)

SI+CC

Experimental

Chest compression will be superimposed by sustained inflations during CPR:

"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.

Intervention: CC+SI (Procedure)

Outcomes

Primary Outcomes

Time Needed to Achieve Return of Spontaneous Circulation

Time Frame: within the first 10 minutes after birth

We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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