Published online December 29, 2008
PEDIATRICS Vol. 123 No. 1 January 2009, pp. 89-96 (doi:10.1542/10.1542/peds.2007-2680)

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ARTICLE

A Pilot Randomized, Controlled Trial of Later Treatment With a Peptide-Containing, Synthetic Surfactant for the Prevention of Bronchopulmonary Dysplasia

Matthew Laughon, MD, MPH^a, Carl Bose, MD^a, Fernando Moya, MD^b, Judy Aschner, MD^c, Steven Mark Donn, MD^d, Christopher Morabito, MD^e, James John Cummings, MD^f, Robert Segal, MD^g, Carlos Guardia, MD^g, Genzhou Liu, PhD^g for the Surfaxin Study Group

^a School of Medicine, University of North Carolina, Chapel Hill, North Carolina
^b Department of Neonatology, New Hanover Regional Medical Center, Wilmington, North Carolina
^c Division of Neonatology, Department of Pediatrics, and Vanderbilt Kennedy Center, Vanderbilt University Medical Center, Nashville, Tennessee
^d Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Michigan Health System, C.S. Mott Children's Hospital, Ann Arbor, Michigan
^e Division of Neonatology, Lehigh Valley Hospital, Allentown, Pennsylvania
^f Brody School of Medicine, East Carolina University, Greenville, North Carolina
^g Discovery Laboratories, Inc, Warrington, Pennsylvania

OBJECTIVE. Oxidant injury and lung inflammation in extremely premature infants are associated with the development of bronchopulmonary dysplasia. Surfactant dysfunction resulting from these events may contribute to the pathogenesis of bronchopulmonary dysplasia. Treatment with exogenous surfactant may decrease the incidence or severity of bronchopulmonary dysplasia. We conducted a masked, multicenter, multinational, randomized, controlled, pilot study to estimate the effects of treating infants at high risk for developing bronchopulmonary dysplasia with lucinactant, a synthetic, peptide-containing surfactant, on safety during dosing and the incidence of death or bronchopulmonary dysplasia.

METHODS. Preterm infants between 600 and 900 g requiring mechanical ventilation and a fraction of inspired oxygen of 0.30 between 3 and 10 days of age were randomly assigned to receive either sham air (placebo) or 1 of 2 doses of lucinactant (90 or 175 mg/kg total phospholipid) every 48 hours to a maximum of 5 doses, if they remained on mechanical ventilation.

RESULTS. Of 136 infants enrolled at 34 sites, 44 received placebo, 47 received 90 mg/kg total phospholipid, and 45 received 175 mg/kg total phospholipid. The 90 mg/kg group had a significantly higher percentage of boys (64%) compared with the placebo group (39%); no other significant differences in baseline characteristics among groups were present. Compared with placebo, both the 90 mg/kg and 175 mg/kg groups experienced a significantly higher incidence of desaturation and bradycardia during dosing. Twenty-four hours after dosing, the mean fraction of inspired oxygen was lower in both lucinactant groups (33%) compared with the placebo group (39%). The incidence of mortality or bronchopulmonary dysplasia was 66% in the placebo group, 79% in the 90 mg/kg group, and 58% in the 175 mg/kg group. These differences were not statistically significant. There were no statistical differences among groups for pneumothorax, pulmonary interstitial emphysema, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, or mortality.

CONCLUSIONS. There were trends toward lower oxygen requirements and toward a lower incidence of mortality or bronchopulmonary dysplasia at 36 weeks' postmenstrual age in infants who received the higher dose of lucinactant, and this warrants further investigation.

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Key Words: premature infant • surfactant • bronchopulmonary dysplasia

Abbreviations: BPD—bronchopulmonary dysplasia • FIO₂—fraction of inspired oxygen • DOL—day of life • S-90—90 mg/kg lucinactant • S-175—175 mg/kg lucinactant • PMA—postmenstrual age • CI—confidence interval • OR—odds ratio

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Accepted Apr 2, 2008.

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