A Multicenter, Randomized, Controlled Trial of Lucinactant Versus Poractant Alfa Among Very Premature Infants at High Risk for Respiratory Distress Syndrome

Abstract

Lucinactant and poractant alfa were similar in terms of efficacy and safety when used for the prevention and treatment of RDS among preterm infants. The ability to enhance the performance of a synthetic surfactant with the addition of a peptide that mimics the action of SP-B, such as sinapultide, brings potential advantages to exogenous surfactant therapy.

Surfactant therapy in preterm infants with respiratory distress syndrome and in near-term or term newborns with acute RDS

“…They differ in composition, onset of response, and duration of action, dosing volume, and the need for additional doses. Fifteen trials [7][8][9][10][11][12][13][14][15][16][17][18][19][20] comparing natural vs synthetic surfactants (Table 1), 21 and seven studies comparing different natural surfactants have been published (Table 2). 21 Multiple, randomized, controlled trials have consistently shown better clinical outcomes during the acute phase of RDS, and improved survival with natural surfactants than with synthetic surfactants that lack surfactant-associated proteins, especially, surfactant protein-B (SP-B).…”

Synthetic surfactants: where are we? Evidence from randomized, controlled clinical trials

“…15 To date there have been two multicenter, phase III, double-blind, randomized, controlled trials examining the efficacy of lucinactant in the prevention of RDS. 15,23 Inclusion criteria, approach to surfactant administration and time periods when the studies were conducted were fairly similar for both trials ( Table 2). The SELECT (Safety and Effectiveness of Lucinactant versus Exosurf in a Clinical Trial) study compared lucinactant with colfosceril.…”

Corrections regarding lucinactant and clinical trials involving lucinactant

“…The dry block heater temperature was set at 44 1C and the lucinactant vials were placed in the dry block heater for 15 min, as summarized in the published reports of the lucinactant trials. 2,3 This procedure avoids imprecision around warming methods using body heat or exposure to room temperatures that may range from 20-25 1C and assures that each dose of surfactant is prepared in an identical way. When warmed for 15 min in a dry block heater set at 44 1C, lucinactant reaches a temperature that approximates body temperature.…”

“…2 In addition, the adjudication committee and the data safety monitoring board were both based in the US. Similarly, the Surfaxin Therapy Against Respiratory distress syndrome (STAR) study included sites in Poland, but these sites made up less than a quarter of the total study sites, 3 and the two top enrolling sites were outside of Poland. If a summary statement of the study site locations is relevant, the most accurate description of study site locations is Europe and Latin America for the SELECT study and Europe and the Americas for the STAR study.…”

“…As stated in the published report, slow enrollment and the futility of attaining full enrollment triggered the study termination. 3 The decision to stop the trial was not influenced by the diversion of financial support to another trial. Dr Halliday concludes that synthetic surfactants are probably not yet ready for the market.…”