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Sustained inflation and chest compression versus 3:1 chest compression to ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns – a cluster randomized controlled trial


Infants (preterm >28 weeks’ gestation and term) requiring chest compression in the delivery room.


Primary Objective

Chest Compression during sustained inflation (CC+SI) will improve short- and long-term outcomes in preterm and term newborns 


Primary Hypothesis

By using CC+SI during cardiopulmonary resuscitation (CPR) the time needed to achieve return of spontaneous circulation (ROSC) compared to the current 3:1 compression to ventilation (C:V) will be reduced in asphyxiated newborns.


Design and Sample Size

This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel design of two alternative courses of treatment. 218 infants – 109 control / 109 intervention


Inclusion Criteria

Infants (preterm and term) requiring chest compression in the delivery room.


Exclusion Criteria 

a) Congenital abnormality

b) Condition that might have an adverse effect on breathing or ventilation (e.g. congenital diaphragmatic hernia)

c) Congenital heart disease requiring intervention in the neonatal period) 

d) Parents’ refusal to give consent to this study


Efficacy Endpoints 


  • Time to achieve return of spontaneous circulation defined as a heart rate of >60/min for 60sec



  • All mortality prior to discharge from hospital

  • Delivery room interventions (use of epinephrine)

  • Admission temperature

  • Use of therapeutic cooling

  • Mechanical ventilation

  • Use of inotropes

  • Infection/sepsis

  • Necrotizing enterocolitis

  • Pneumothorax

  • Bronchoplumonary dysplasia

  • Retinopathy of prematurity 

  • Brain injury as indicated by abnormal neuroimaging

  • Seizure 

  • 18-24 months neuro-developmental outcomes


Safety Evaluations 

Adverse events


Statistical Methodology

Interim analyses will be conducted when 10%, 25% and 50% of participants complete primary outcome. The final analysis will be conducted after the study is completed, unblinded, and the database is released for analysis. All analyses will be performed using IBM SPSS Statistics Ver. 24 (IBM Corp.) and SAS version 9.4 (SAS Institute Inc.) or later.

Clinical Centers

Canada and Austria

Enrolment Period: 2 years

ClinicalTrials.Gov Trial: NCT02858583

Study protocol has been published in Trials in 2019

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