Visiting the Ritchie Centre, Monash University, Melbourne Australia

I am at the Ritchie Centre at Monash University, an amazing research hub dedicated to fetal, neonatal, and child health.

I am presenting my work over the last decade in improving chest compression and how CC+SI - Chest Compression superimposed by Sustained inflation might improve outcome and the upcoming SURV1VE-2-Trial.

As well as Vasopressin an alternative to Epinephirne during neonatal cardiopulmonary resuscitation and the ongoing VERSE-Trial.

SURV1VE-Trial: Sustained Inflation and Chest Compression vs. 3:1 Compression-to-Ventilation Ratio

The SURV1VE-Trial is an international multi-center randomized controlled trial comparing two CPR strategies in asphyxiated newborns:

1. Sustained Inflation with Chest Compressions (CC+SI)

2. Standard 3:1 Compression-to-Ventilation (C:V) Ratio

Primary Objective

To determine whether CC+SI improves short- and long-term outcomes in preterm and term newborns requiring chest compressions in the delivery room.

Primary Hypothesis

Using CC+SI during neonatal CPR will reduce the time to achieve ROSC compared to the current 3:1 C:V ratio.

Study Design & Sample Size

• Prospective, multi-national RCT

• Two-arm parallel design

• 554 infants (277 control / 277 intervention)

Inclusion & Exclusion Criteria

• Inclusion: Infants (preterm >28 weeks’ gestation and term) requiring chest compression.

• Exclusion: Congenital abnormalities, conditions affecting ventilation, congenital heart disease requiring neonatal intervention, and parental refusal to consent.

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Efficacy Endpoints

• Primary: All-cause mortality within 28 days after birth

• Secondary: Time to achieve ROSC, delivery room interventions (epinephrine use), admission temperature, use of therapeutic hypothermia, mechanical ventilation, inotropes, infections, pneumothorax, brain injury, seizures, 18-24 month neurodevelopmental outcomes.

Safety Evaluations & Statistical Methods

• Adverse event monitoring.

• Interim analyses at 25% and 50% of enrollment completion.

• Final analysis will be conducted unblinded once the study database is released.

• Statistical tools: IBM SPSS Statistics Ver. 24 and SAS version 9.4.

This trial will be being conducted aorund trhe world and has been registered under ClinicalTrials.Gov (NCT06577818).

VERSE-Trial: Vasopressin vs Epinephrine in Neonatal Resuscitation

The VERSE-Trial is a cluster randomized controlled trial comparing vasopressin and epinephrine during cardiopulmonary resuscitation (CPR) of newborns requiring chest compressions and cardiovascular supportive medication in the delivery room.

Primary Objective

The study aims to determine whether vasopressin improves short- and long-term outcomes in preterm and term newborns compared to epinephrine.

Primary Hypothesis

Vasopressin will reduce the time needed to achieve return of spontaneous circulation (ROSC) in asphyxiated newborns compared to epinephrine.

Study Design & Sample Size

• Prospective single-center cluster RCT

• 10-20 infants enrolled

Inclusion & Exclusion Criteria

• Inclusion: Newborns requiring chest compression and cardiovascular supportive medication in the delivery room.

• Exclusion: Congenital abnormalities, conditions affecting breathing or ventilation, congenital heart disease requiring neonatal intervention, and parental refusal to consent.

Efficacy Endpoints

• Primary: Time to achieve ROSC (HR >60/min for 60 sec)

• Secondary: Mortality prior to discharge, delivery room interventions, use of therapeutic hypothermia, mechanical ventilation, inotropes, infection, NEC, BPD, ROP, brain injury, seizures.

Safety Evaluations & Statistical Methods

• Adverse events monitoring.

• Interim analyses will be conducted after each vasopressin-enrolled patient to assess safety.

• Final analysis will follow an intention-to-treat approach.

This trial is being conducted in Canada and has been registered under ClinicalTrials.Gov (NCT05738148). The study protocol was published in ResuscitationPlus (2023).

Both VERSE and SURV1VE trials have the potential to reshape neonatal resuscitation guidelines by optimizing cardiovascular support strategies for asphyxiated newborns.

Stay tuned for further updates on these exciting studies!