The pilot study is intended to document and demonstrate the feasibility of conducting a large multi-center, randomized, controlled clinical trial in very low birth weight infants comparing the effectiveness of two early ventilation strategies: non-tidal ventilation, as delivered by HFOV; and tidal ventilation, as delivered by SIMV. The study design and protocols are prototypes developed for the larger trial. Ventilator protocols were developed flowing discussions between the pilot study key personnel and other recognized experts in neonatal ventilation. Experience with these protocols will provide valuable data for improving the final study plan.
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