Chest Compression and Sustained Inflation

NCT02083705 | Completed Results DMC

• 1 other identifier: Pro00034524_CC
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn Infants Having Asystole or Bradycardia at Birth

Keywords

Chest compression, Delivery Room, NICU,

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Procedure: CC+SI

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.

Procedure: 3:1 CPR

Interventions

CC+SI PROCEDURE

Chest compression will be superimposed by sustained inflation during CPR

SI+CC

3:1 CPR PROCEDURE

CPR using 3:1 ratio (control group)

3:1 CPR

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn infants with asystole Newborn infants with bradycardia

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (1)

• Schmolzer GM, O Reilly M, Fray C, van Os S, Cheung PY. Chest compression during sustained inflation versus 3:1 chest compression:ventilation ratio during neonatal cardiopulmonary resuscitation: a randomised feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F455-F460. doi: 10.1136/archdischild-2017-313037. Epub 2017 Oct 7.

  PMID: 28988159 DERIVED

MeSH Terms

Interventions

Cardiopulmonary Resuscitation

Intervention Hierarchy (Ancestors)

Resuscitation; Emergency Treatment; Therapeutics

Results Point of Contact

• Title: Georg Schmölzer
• Organization: University of Alberta

georg.schmoelzer@me.com

7807354647

Study Officials

• Georg Schmolzer

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: March 11, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 30, 2025
• Results First Posted: September 20, 2024

Record last verified: 2025-03

Locations

CA (1)