The SURV1VE trial-sustained inflation and chest compression versus 3:1 chest compression-to-ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns: study protocol for a cluster randomized controlled trial

Abstract

Background: The need for cardiopulmonary resuscitation (CPR) is often unexpected, and the infrequent use of CPR in the delivery room (DR) limits the opportunity to perform rigorous clinical studies to determine the best method for delivering chest compression (CC) to newborn infants. The current neonatal resuscitation guidelines recommend using a coordinated 3:1 compression-to-ventilation (C:V) ratio (CC at a rate of 90/min and ventilations at a rate of 30/min). In comparison, providing CC during a sustained inflation (SI) (CC + SI) significantly improved hemodynamics, minute ventilation, and time to return of spontaneous circulation (ROSC) compared to 3:1 C:V ratio in asphyxiated piglets. Similarly, a small pilot trial in newborn infants showed similar results. Until now no study has examined different CC techniques during neonatal resuscitation in asphyxiated newborn infants in the DR. To date, no trial has been performed to directly compare CC + SI and 3:1 C:V ratio in the DR during CPR of asphyxiated newborn infants.

Methods: This is a large, international, multi-center, prospective, unblinded, cluster randomized controlled trial in asphyxiated newborn infants at birth. All term and preterm infants > 28+ 0 by best obstetrical estimate who require CPR at birth due to bradycardia (< 60/min) or asystole are eligible. The primary outcome of this study is to compare the time to ROSC in infants born > 28+ 0 weeks' gestational age with bradycardia (< 60/min) or asystole immediately after birth who receive either CC + SI or 3:1 C:V ratio as the CPR strategy.

Discussion: Morbidity and mortality rates are extremely high for newborns requiring CC. We believe the combination of simultaneous CC and SI during CPR has the potential to significantly improve ROSC and survival. In addition, we believe that CC + SI might improve respiratory and hemodynamic parameters and potentially minimize morbidity and mortality in newborn infants. In addition, this will be the first randomized controlled trial to examine CC in the newborn period.

Trial registration: ClinicalTrials.gov, NCT02858583 . Registered on 8 August 2016.

Conflict of interest statement

Ethics approval and consent to participate

The SURV1VE trial will be conducted in compliance with the guidelines of the Declaration of Helsinki in its latest form, the International Conference on Harmonization of Good Clinical Practice Guidelines [39]. In case of modifications in the study protocol that are not merely of a formal nature but contain changes pertinent to the study participants, a renewed vote of the relevant ethics committees will be obtained. If applicable, the patients (parents) will be informed in the patient information and consent form about changes in the terms and conditions of the trial. The SURV1VE trial will only start the randomization of participants after approvals from the relevant ethics committees have been obtained. The SURV1VE trial has been approved by the Human Research Ethics Board, University of Alberta, Edmonton, Canada (Pro00066739). In case of a necessary protocol amendment, the amendment will be submitted to the ethics committee.

Consent for publication

Not applicable. Results will be presented at relevant national and international conferences as well as being published in peer-reviewed journals.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Example template of recommended content for the schedule of enrollment, interventions, and assessments*

Fig. 2

Study flow chart