Objective The Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration showed that high (91–95%) versus low (85–89%) SpO2 targets 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 SpO2 92–97% to facilitate the design of future trials.
Design Single-centre prospective randomised crossover pilot study. Manual FiO2 adjustment. Study time 12 hours per infant. 6 hours targeting SpO2 90–95% and 6 hours targeting SpO2 92–97%.
Patients Twenty preterm infants born <29 weeks’ gestation, greater than 48 hours old, receiving supplemental oxygen.
Outcomes Primary outcome was percentage time with SpO2 above 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).
Results With SpO2 target 92–97% versus 90–95%, the mean (IQR) percentage time above SpO2 97% 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 TcPO2 10.7 kPa (80 mm Hg) was 1.4% (0–1.4) versus 1.8% (0–0), p=0.746.
Conclusions Targeting SpO2 92–97% produced a right shift in SpO2 and TcPO2 distribution, 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 SpO2 range could be conducted without significant hyperoxic exposure.
Trial registration number NCT03360292.
- intensive care units, neonatal
Data availability statement
All data relevant to the study are included in the article or uploaded as online supplemental information.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Twitter @fgchr, @rodkelly50, @JamesPBoardman
Contributors FGC reviewed study design, obtained ethical approval, conducted patient recruitment and data collection, performed statistical analysis, drafted the initial manuscript. RK conceptualised and designed the study, obtained ethical approval, reviewed the manuscript. JPB reviewed study design and the manuscript. BJS conceptualised and designed the study, obtained ethical approval, supervised patient recruitment, data collection and statistical analysis, reviewed the manuscript. FGC is responsible for the overall content as guarantor.
Funding This work was supported by Simpsons Special Care Babies (SSCB).
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.