Table 1.
Trial | Dates | Enrolled | Exclusion | % not meeting inclusion criteria | Geography | Birth weight (mean or range) | Intervention | Outcome | Mortality |
---|---|---|---|---|---|---|---|---|---|
STOP-ROP | 1994–1999 | 30–48 weeks GA with prethreshold ROP in one eye and median SaO2 <94% | Median SaO2>94% or congenital abnormality | 34% | United States | 726 grams | Infants randomized to SaO2 ranges of 89–94% or 96–99% | No significant difference in threshold ROP. In subgroup, threshold ROP < infants without Plus disease in 96–99% SaO2 group | Not assessed formally 7 infants in lower oxygen tension group vs. 9 infants in the higher tension group died) |
Support | 2005–2009 | 24–27 weeks GA 6 days at birth who underwent full resuscitation | Infants with major congenital abnormalities | 6.6% | United States | 825–836 grams |
|
Decreased ROP in 85–89% SaO2 group | Increased mortality in 85–89% SaO2 group |
BOOST II | 2006–2011 | <28 weeks GA |
|
9% | Australia, UK, New Zealand | 826–837 grams | Randomized to SaO2 of 85–89% or 91–95% | Decreased ROP in 85–89% SaO2 group | Increased mortality when targeting SaO2 <90% |
COT | 2006–2012 | >23 weeks to 27 weeks and 6 days GA |
|
16% | Canada, United States, Argentina Finland, Germany Israel | 827–845 grams | Randomized to SaO2 of 85–89% or 91–95% | No significant difference between SaO2 targets on ROP at 18 months | No significant difference between SaO2 targets on death or disability at 18 months |
GA-gestational age; SaO2 – oxygen saturation; STOP-ROP - Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity; BOOST – Benefits of Oxygen Saturation Targeting; SUPPORT - Surfactant, Positive Airway Pressure, Pulse Oximetry Randomized Trial; COT – Canadian Oxygen Trial