saline placebo-Atlantic Health System-cerebral hemorrhagic-ischemic injury-intraventricular hemorrhage-periventricular leukomalacia

This saline placebo (0.9% sodium chloride solution) is used as the control arm in a Phase II clinical trial sponsored by Atlantic Health System. The trial evaluates the safety and tolerability of high-dose recombinant human erythropoietin for neuroprotection in very low birth weight (VLBW) infants weighing less than 1250 grams. The placebo is administered intravenously at a volume of 1 mL once daily for the first seven days of life, matching the administration schedule and volume of the active treatment. It serves as a comparator to assess the efficacy of erythropoietin in preventing or attenuating prematurity-related brain injuries, specifically cerebral hemorrhagic-ischemic injury, intraventricular hemorrhage, and periventricular leukomalacia. As a placebo, it contains no active pharmaceutical ingredient and is intended to provide a baseline for evaluating the biologic effects of the study drug.

Other names

saline placebosaline vehicle