Visiting the Royal Women's Hospital, Melbourne Australia

I visited the Royal Women's Hospital in Melbourne, not only a renowned research hub dedicated to maternal, fetal, and neonatal health. It was also where I completed my Neonatal Fellwoship.

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

The SURV1VE-2 trial has the potential to reshape neonatal resuscitation guidelines by optimizing cardiovascular support strategies for asphyxiated newborns.

Stay tuned for further updates on SURV1VE!