SUPPORT (USA).

Trial name or title	The surfactant positive airway pressure and pulse oximetry trial in extremely low birth weight infants
Methods	This is a prospective, randomized, factorial 2x2 design multi‐centre trial. Randomization will be stratified by gestational age, and will be done utilizing double‐sealed envelopes. The individual factors to be tested will be: 1) A prospective comparison of CPAP and a permissive ventilatory strategy begun in the delivery room and continuing in the NICU with early (<1 hour) surfactant and mechanical ventilation; 2) A prospective comparison of a lower SpO2 range (85% to 89%) with a higher more conventional SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen. The intervention monitored through Masimo Radical SET pulse oximeters are masked by offsetting the assigned SpO2 by +/‐3% points. Staff will (a) target SpO2 88‐92% and (b) aim to maximize time spent with SpO2 between 85‐95%. From 85‐95%, the offset will be 3% above or below the actual SpO2. Outside 85‐95%, study oximeters read actual SpO2. Power has been calculated to be 80% for detecting an absolute difference of 10% in the primary and secondary outcomes, with a sample size of 1310.
Participants	Infants <27 weeks' gestation at birth and <24 hours old
Interventions	Lower (Fn SpO2 85‐89%) vs higher (Fn SpO2 91‐95%) O2 targeting
Outcomes	Death or major disability at 2 years corrected age, survival without BPD at 36 weeks, survival without ROP, other secondary outcomes
Starting date	February 2005
Contact information	Dr Neil Finer; Email: nfiner@ucsd.edu
Notes