A Phase Ib/IIa Randomized, Placebo Controlled Study of the Safety and Efficacy of Once Daily Dosing of STP206 in Premature Very Low Birth Weight and Extremely Low Birth Weight Neonates

880724
Pediatrics
Dr. Rachana Singh
Baystate Medical Center 759 Chestnut Street Springfield, MA 01199
The study will be conducted in two parts. Part A will determine the safety and tolerability of two doses of the study drug, STP206, versus control. Part B will evaluate the safety and efficacy of the study drug, STP206, in very low and extremely low birth weight neonates for prevention of Necrotizing Enterocolitis (NEC).
Neonates with birth weights between 500- 2000g for Part A and 500- 1500g for Part B who have the ability to start treatment within four days after birth and had a gestational age between 23 and 32 weeks at birth.
Dr. Rachana Singh
413-794-2400