PatientsVille.com LogoPatientsVille.com

Newborn Infants Having Asystole or Bradycardia at Birth | Chest Compression and Sustained Inflation

Newborn Infants Having Asystole or Bradycardia at Birth research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: Newborn infants with asystole Newborn infants with bradycardia Exclusion Criteria:

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Newborn Infants Having Asystole or Bradycardia at Birth

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:CC+SIChest compression will be superimposed by sustained inflation during CPR

Procedure:3:1 CPRCPR using 3:1 ratio (control group)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

SI+CCChest 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.

3:1 CPRCPR 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.

Study Status

Completed

Start Date: January 2014

Completed Date: October 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Time needed to achieve Return of Spontaneous Circulation

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Georg Schmolzer

Lead Sponsor: University of Alberta

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02083705

Discuss Bradycardia