Measuring Oxygenation in Newborn Infants with Targeted Oxygen Ranges (MONITOR): a randomised crossover pilot study

Abstract

ObjectiveThe Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration showed that high (91–95%) versus low (85–89%) SpO2targets reduced mortality. Trials of higher targets are needed to determine whether any more survival advantage may be gained. This pilot study explored the achieved oxygenation patterns observed when targeting SpO292–97% to facilitate the design of future trials.DesignSingle-centre prospective randomised crossover pilot study. Manual FiO2adjustment. Study time 12 hours per infant. 6 hours targeting SpO290–95% and 6 hours targeting SpO292–97%.PatientsTwenty preterm infants born <29 weeks’ gestation, greater than 48 hours old, receiving supplemental oxygen.OutcomesPrimary outcome was percentage time with SpO2above 97% and below 90%. Pre-defined secondary outcomes included percentage time spent within, above or below transcutaneous PO2(TcPO2) 6.7–10.7 kPa (50–80 mm Hg). Comparisons were made using paired-samples t-test (2-tailed).ResultsWith SpO2target 92–97% versus 90–95%, the mean (IQR) percentage time above SpO297% was 11.3% (2.7–20.9) versus 7.8% (1.7–13.9), p=0.02. Percentage time with SpO2<90% was 13.1% (6.7–19.1) versus 17.9% (11.1–22.4), p=0.003. Percentage time with SpO2<80% was 1% (0.1–1.4) versus 1.6% (0.4–2.6), p=0.119. Percentage time with TcPO2<6.7 kPa (50 mm Hg) was 49.6% (30.2–66.0) versus 55% (34.3–73.5), p=0.63. Percentage time above TcPO210.7 kPa (80 mm Hg) was 1.4% (0–1.4) versus 1.8% (0–0), p=0.746.ConclusionsTargeting SpO292–97% produced a right shift in SpO2and TcPO2distribution, with reduced time at SpO2<90% and increased time at SpO2>97%, without increasing time with TcPO2>10.7 kPa (80 mm Hg). Clinical trials targeting this higher SpO2range could be conducted without significant hyperoxic exposure.Trial registration numberNCT03360292.