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.
Chest Compression during sustained inflation (CC+SI) will improve short- and long-term outcomes in preterm and term newborns
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
Infants (preterm and term) requiring chest compression in the delivery room.
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
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)
Use of therapeutic cooling
Use of inotropes
Retinopathy of prematurity
Brain injury as indicated by abnormal neuroimaging
18-24 months neuro-developmental outcomes
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.
Canada and Austria
Enrolment Period: 2 years
ClinicalTrials.Gov Trial: NCT02858583