Chest Compression and Sustained Inflation

Newborn Infants Having Asystole or Bradycardia at Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083705
• Other study ID #: Pro00034524_CC
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: January 6, 2017
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: January 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

Newborn infants with asystole Newborn infants with bradycardia

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bradycardia
• Heart Arrest
• Newborn Infants Having Asystole or Bradycardia at Birth

Intervention

Procedure:
• CC+SI
Chest compression will be superimposed by sustained inflation during CPR
• 3:1 CPR
CPR using 3:1 ratio (control group)

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time needed to achieve Return of Spontaneous Circulation	We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique	within the first 10 minutes after birth	No