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 < or =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.