RCTs of Differing Pulse Oximetry Targets
| Study . | Primary Outcome . | Primary Outcome Results . | Other Findings . |
|---|---|---|---|
| STOP-ROP39 | Rate of progression to threshold ROP (89%–94% vs 96%–99%) | No significant differences | • Higher saturation range exhibited worsening of chronic lung disease and longer duration of hospitalization |
| N = 649 | |||
| BOOST40 | Growth and developmental outcomes (91%–94% vs 95%–98%) | No significant differences | • Higher saturation range required oxygen for a longer period of time, dependence on oxygen at 36 wk postmenstrual age, and need for home oxygen |
| N = 358 | |||
| SUPPORT43,44 | Death, severe ROP, or both (85%–89% vs 91%–95%) | No significant differences | • Severe ROP significantly more common in the higher Sao2 range |
| N = 1316 | • Increased mortality in the lower Sao2 range at 18–22 mo of corrected age | ||
| • No significant difference in the composite outcome of death or neurodevelopmental impairment at 18–22 mo | |||
| BOOST II45,–48 | Death or neurodevelopmental impairment at 18–22 mo of corrected for prematurity (85%–89% vs 91%–95%) | No significant differences in a pooled analysis of all 3 trials47 | • Change in oximeter algorithm during the study |
| No significant difference in individual trial analyses46,48 | • Study stopped before complete enrollment | ||
| N = 2448 | In a post hoc analysis combining 2 of the 3 trials, the primary outcome occurred in 492 (48.1%) of 1022 in the lower target group versus 437 (43.1%) of 1013 in the higher target group (RR, 1.11 [95% CI, 1.01–1.23]; P = .023)46 | • Severe ROP significantly more common in the higher Sao2 range | |
| • Significantly increased necrotizing enterocolitis at the lower saturation range | |||
| • Significantly increased mortality at hospital discharge in the lower Sao2 range with the revised oximeter algorithm | |||
| COT49 | Death before a corrected age of 18 mo or survival with ≥1 of the following: gross motor disability, cognitive or language delay, severe hearing loss, and bilateral blindness (85%–89% vs 91%–95%) | No significant differences | • Change in oximeter algorithm during the study |
| N = 1201 | • No difference in mortality | ||
| • Targeting the lower saturation range reduced the postmenstrual age at last use of oxygen therapy |
| Study . | Primary Outcome . | Primary Outcome Results . | Other Findings . |
|---|---|---|---|
| STOP-ROP39 | Rate of progression to threshold ROP (89%–94% vs 96%–99%) | No significant differences | • Higher saturation range exhibited worsening of chronic lung disease and longer duration of hospitalization |
| N = 649 | |||
| BOOST40 | Growth and developmental outcomes (91%–94% vs 95%–98%) | No significant differences | • Higher saturation range required oxygen for a longer period of time, dependence on oxygen at 36 wk postmenstrual age, and need for home oxygen |
| N = 358 | |||
| SUPPORT43,44 | Death, severe ROP, or both (85%–89% vs 91%–95%) | No significant differences | • Severe ROP significantly more common in the higher Sao2 range |
| N = 1316 | • Increased mortality in the lower Sao2 range at 18–22 mo of corrected age | ||
| • No significant difference in the composite outcome of death or neurodevelopmental impairment at 18–22 mo | |||
| BOOST II45,–48 | Death or neurodevelopmental impairment at 18–22 mo of corrected for prematurity (85%–89% vs 91%–95%) | No significant differences in a pooled analysis of all 3 trials47 | • Change in oximeter algorithm during the study |
| No significant difference in individual trial analyses46,48 | • Study stopped before complete enrollment | ||
| N = 2448 | In a post hoc analysis combining 2 of the 3 trials, the primary outcome occurred in 492 (48.1%) of 1022 in the lower target group versus 437 (43.1%) of 1013 in the higher target group (RR, 1.11 [95% CI, 1.01–1.23]; P = .023)46 | • Severe ROP significantly more common in the higher Sao2 range | |
| • Significantly increased necrotizing enterocolitis at the lower saturation range | |||
| • Significantly increased mortality at hospital discharge in the lower Sao2 range with the revised oximeter algorithm | |||
| COT49 | Death before a corrected age of 18 mo or survival with ≥1 of the following: gross motor disability, cognitive or language delay, severe hearing loss, and bilateral blindness (85%–89% vs 91%–95%) | No significant differences | • Change in oximeter algorithm during the study |
| N = 1201 | • No difference in mortality | ||
| • Targeting the lower saturation range reduced the postmenstrual age at last use of oxygen therapy |
COT, Canadian Oxygen Trial; BOOST, Benefits of Oxygen Saturation Targeting; STOP, Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity; SUPPORT, Surfactant Positive Airway Pressure and Pulse Oximetry Trial.