Oxygen Saturation Targeting for Infants with Bronchopulmonary Dysplasia: A Pilot Randomized Trial.

Abstract

Rationale: The optimal target oxygen saturation (Sp_O2) range in infants with established bronchopulmonary dysplasia (BPD) is unknown. Objectives: To compare the incidence of intermittent hypoxemia (IH), proportion of time with hypoxemia, and secondary clinical outcomes measured up to 6 months corrected age (CA) in infants with established BPD randomized to higher (⩾96%) versus lower (90-94%) Sp_O2 target ranges. Methods: Fifty infants born at <30 weeks gestational age who received supplemental respiratory support at 36 weeks postmenstrual age (PMA) were randomized before 44 weeks PMA to higher (n = 22) or lower (n = 28) Sp_O2 target ranges. Continuous pulse oximetry data were analyzed weekly to guide titration of respiratory support until 6 months CA. Primary outcomes were the incidence of IH (Sp_O2 < 80% for ⩾30 s) and proportion of time with hypoxemia (<80%) over the entire study period. Secondary outcomes were hypoxemia defined using alternative durations (⩾10 and ⩾60 s) and Sp_O2 thresholds (<90%) and clinical and developmental outcomes assessed through 6 months CA. Post hoc analyses compared rates of hypoxemia between the two study groups from enrollment to 48 weeks PMA among infants with at least 4 weeks of study data. Results: Median duration of monitoring was 19.0 (interquartile range [IQR], 8.5-23.0) weeks, yielding 835 (IQR, 412-1,269) hours of data per participant. Over the entire study period, there was no difference between Sp_O2 target groups in the primary outcomes of median numbers of IH events <80% for ⩾30 seconds or time with Sp_O2 < 80%. Post hoc analyses of infants with at least 4 weeks of study data demonstrated higher incidence of IH events <80% and <90% for both ⩾60 and ⩾30 seconds between enrollment and 48 weeks PMA in the lower target group. Infants in the lower Sp_O2 target group were discharged at later PMA than infants in the higher Sp_O2 target group (median, 48.0 vs. 45.0 wk; P = 0.05). Conclusions: A higher (⩾96%) compared with lower (90-94%) Sp_O2 target strategy is unlikely to significantly reduce hypoxemia between 36-44 weeks PMA and 6 months CA. A possible decrease in IH before 48 weeks PMA and modest clinical improvements associated with the higher target range will require confirmation in future studies. Clinical trial registered with www.clinicaltrials.gov (NCT03385330).