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TABLE 1

RCTs of Differing Pulse Oximetry Targets

StudyPrimary OutcomePrimary Outcome ResultsOther 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 
StudyPrimary OutcomePrimary Outcome ResultsOther 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.

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