Published online April 1, 2005
PEDIATRICS Vol. 115 No. 4 April 2005, pp. 1018-1029 (doi:10.1542/peds.2004-2183)
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A Multicenter, Randomized, Masked, Comparison Trial of Lucinactant, Colfosceril Palmitate, and Beractant for the Prevention of Respiratory Distress Syndrome Among Very Preterm Infants

Fernando R. Moya, MD*, Janusz Gadzinowski, MD, PhD{ddagger}, Eduardo Bancalari, MD§, Vicente Salinas, MD||, Benjamin Kopelman, MD, Aldo Bancalari, MD#, Maria Katarzyna Kornacka, MD, PhD**, T. Allen Merritt, MD{ddagger}{ddagger}, Robert Segal, MD§§, Christopher J. Schaber, PhD§§, Huei Tsai, PhD§§, Joseph Massaro, PhD||||, Ralph d'Agostino, PhD¶¶ for the International Surfaxin Collaborative Study Group

* Department of Pediatrics, University of Texas Health Science Center at Houston, Houston, Texas
{ddagger} University of Medical Sciences, Poznan, Poland, and Polish Mother's Memorial Hospital Research Institute, Lodz, Poland
§ Jackson Memorial Hospital, University of Miami, Miami, Florida
|| National Institute of Perinatology, Mexico City, Mexico
Hospital São Paulo, University of Sao Paulo, Paulista School of Medicine, Sao Paulo, Brazil
# Regional Clinical Hospital Guillermo Grant-Benavente, University of Concepción, Concepción, Chile
** Neonatology Clinic, Warsaw Medical University, Warsaw, Poland
{ddagger}{ddagger} St Charles Medical Center, Bend, Oregon
§§ Discovery Laboratories, Doylestown, Pennsylvania
|||| Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts
¶¶ Statistics and Consulting Unit, Department of Mathematics and Statistics, Boston University, Boston, Massachusetts

Background and Objective. Evidence suggests that synthetic surfactants consisting solely of phospholipids can be improved through the addition of peptides, such as sinapultide, that mimic the action of human surfactant protein-B (SP-B). A synthetic surfactant containing a mimic of SP-B may also reduce the potential risks associated with the use of animal-derived products. Our objective was to compare the efficacy and safety of a novel synthetic surfactant containing a functional SP-B mimic (lucinactant; Discovery Laboratories, Doylestown, PA) with those of a non–protein-containing synthetic surfactant (colfosceril palmitate; GlaxoSmithKline, Brentford, United Kingdom) and a bovine-derived surfactant (beractant; Abbott Laboratories, Abbott Park, IL) in the prevention of neonatal respiratory distress syndrome (RDS) and RDS-related death.

Methods. We assigned randomly (double-masked) 1294 very preterm infants, weighing 600 to 1250 g and of ≤32 weeks gestational age, to receive colfosceril palmitate (n = 509), lucinactant (n = 527), or beractant (n = 258) within 20 to 30 minutes after birth. Primary outcome measures were the rates of RDS at 24 hours and the rates of death related to RDS during the first 14 days after birth. All-cause mortality rates, bronchopulmonary dysplasia (BPD) rates, and rates of other complications of prematurity were prespecified secondary outcomes. Primary outcomes, air leaks, and causes of death were assigned by an independent, masked, adjudication committee with prespecified definitions. The study was monitored by an independent data safety monitoring board.

Results. Lucinactant reduced significantly the incidence of RDS at 24 hours, compared with colfosceril (39.1% vs 47.2%; odds ratio [OR]: 0.68; 95% confidence interval [CI]: 0.52–0.89). There was no significant difference in comparison with beractant (33.3%). However, lucinactant reduced significantly RDS-related mortality rates by 14 days of life, compared with both colfosceril (4.7% vs 9.4%; OR: 0.43; 95% CI: 0.25–0.73) and beractant (10.5%; OR: 0.35; 95% CI: 0.18–0.66). In addition, BPD at 36 weeks postmenstrual age was significantly less common with lucinactant than with colfosceril (40.2% vs 45.0%; OR: 0.75; 95% CI: 0.56–0.99), and the all-cause mortality rate at 36 weeks postmenstrual age was lower with lucinactant than with beractant (21% vs 26%; OR: 0.67; 95% CI: 0.45–1.00).

Conclusions. Lucinactant is a more effective surfactant preparation than colfosceril palmitate for the prevention of RDS. In addition, lucinactant reduces the incidence of BPD, compared with colfosceril palmitate, and decreases RDS-related mortality rates, compared with beractant. Therefore, we conclude that lucinactant, the first of a new class of surfactants containing a functional protein analog of SP-B, is an effective therapeutic option for preterm infants at risk for RDS.

Key Words: lucinactant • colfosceril palmitate • beractant • surfactant • respiratory distress syndrome

Abbreviations: RDS, respiratory distress syndrome • BPD, bronchopulmonary dysplasia • OR, odds ratio • CI, confidence interval • IVH, intraventricular hemorrhage • PVL, periventricular leukomalacia • PMA, postmenstrual age • SP, surfactant protein • DPPC, dipalmitoylphosphatidylcholine • FIO2, fraction of inspired oxygen

Accepted Dec 6, 2004.




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