Colorimetric CO2 Detector to Improve Effective Mask Ventilations in Very Preterm Infants: A Pilot Randomized Controlled Study

Abstract

Introduction: End-tidal CO₂ (ETCO₂) detector is currently recommended for confirmation of endotracheal tube placement during neonatal resuscitation. Whether it is feasible to use ETCO₂ detectors during mask ventilation to reduce risk of bradycardia and desaturations, which are associated with increased risk of death in preterm babies, is unknown. Methods: This is a pilot randomized controlled trial (NCT04287907) involving newborns 24 + 0/7 to 32 + 0/7 weeks gestation who required mask ventilation at birth. Infants were randomized into groups with or without colorimetric ETCO₂ detectors. Combined duration of any bradycardia (<100 bpm) and time below prespecified target oxygen saturation (SpO₂) as measured by pulse oximetry were compared. Results: Fifty participants were randomized, 47 with outcomes analysed (2 incomplete data, 1 postnatal diagnosis of trachea-oesophageal fistula). Mean gestational age and birthweight were 28.5 ± 1.9 versus 29.4 ± 1.6 weeks (p = 0.1) and 1,252.7 ± 409.7 g versus 1,334.6 ± 369.1 g (p = 0.5) in the intervention and control arm, respectively. Mean combined duration of bradycardia and desaturation was 276.7 ± 197.7 s (intervention) and 322.7 ± 277.7 s (control) (p = 0.6). Proportion of participants with any bradycardia or desaturation at 5 min were 38.1% (intervention) and 56.5% (control) (p = 0.2). No chest compressions, epinephrine administration, or death occurred in the delivery room. Conclusion: This pilot study demonstrates the feasibility of a trial to evaluate colorimetric ETCO₂ detectors during mask ventilation of very preterm infants to reduce bradycardia and low SpO₂. Further assessment with a larger population will be required to determine if ETCO₂ detector usage at resuscitation reduces risk of adverse outcomes, including death and disability, in very preterm infants.