ECONOMIC OUTCOMES OF COLFOSCERIL PALMITATE RESCUE THERAPY IN INFANTS WEIGHING 1250G OR MORE WITH RESPIRATORY-DISTRESS SYNDROME - RESULTS FROM A RANDOMIZED TRIAL

An analysis of the economic data from a multicentre, randomised, place bo-controlled clinical trial of colfosceril palmitate in infants with neonatal respiratory distress syndrome (NRDS) and birthweights of 1250 g or more is presented. Two 5 ml/kg (67.5 mg/kg) doses of a synthetic surfactant (colfosceril palmitate) or air placebo were administered to 1237 infants who were receiving mechanical ventilation and had an art erial/alveolar oxygen tension ratio of less than 0.22. In addition to the clinical end-points for safety and efficacy, data were collected o n length of hospital stay, days in the neonatal intensive care unit, d ays on mechanical ventilation, days on oxygen, and hospital charges un til the child reached 1-year adjusted age. One-year adjusted age is at tained when the time elapsed since birth is equal to 365 days plus the number of days of prematurity. Rescue treatment with synthetic surfac tant therapy has been shown to reduce the incidence of complications o f NRDS. Growth and development of infants who received colfosceril pal mitate therapy in the study and survived to 1-year adjusted age were e quivalent to those of the survivors in the air placebo group. For the cohort of treated infants, colfosceril palmitate reduced the average l ength of stay at 2 levels of care needed during both the initial hospi talisation (a reduction of 8 days overall and 5 days in intensive care ) and all first year hospitalisations (a reduction of 9 days overall a nd 5 days in intensive care). Total hospital charges for the initial h ospitalisation and through 1-year adjusted age for ahypothetical cohor t of 100 infants treated with colfosceril palmitate were less than tho se for a comparable cohort in the air placebo group. The results would , therefore, suggest that rescue therapy with colfosceril palmitate in infants with NRDS and birthweights over 1250g can result in substanti al reductions in hospital resource utilisation and charges in addition to the clinical benefits associated with its use.