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PEDIATRICS Vol. 100 No. 1 July 1997, pp. 39-50

A Multicenter Randomized Masked Comparison Trial of Synthetic Surfactant Versus Calf Lung Surfactant Extract in the Prevention of Neonatal Respiratory Distress Syndrome

Received Nov 6, 1995; accepted Jun 24, 1996.

Mark L. Hudak*, David J. MartinDagger , Edmund A. Egan*, Elizabeth J. Matteson*, J. Cummings*, August L. Jung§, Lois V. Kimberlinparallel , Richard L. Auten, Adam A. Rosenberg#, Jeanette M. Asselin**, Marc R. BelcastroDagger Dagger , Pamela K. Donohue§§, Charles R. Hamm Jr||, Robert D. Jansen¶¶, Alan S. BrodyDagger , Merchline M. RiddlesbergerDagger , and Paul MontgomeryDagger

From the * Departments of Pediatrics and Dagger  Pediatric Radiology, Children's Hospital of Buffalo, State University of New York at Buffalo, Buffalo, NY; the § Department of Pediatrics, University of Utah Medical Center, Salt Lake City, UT; the parallel  Department of Pediatrics, Evanston Hospital, Evanston IL; the  Department of Pediatrics, Duke University Medical Center, Durham, NC; the # Department of Pediatics, University of Colorado Health Sciences Center, Denver, CO; the ** Division of Neonatology, Children's Hospital of Oakland, Oakland, CA; the Dagger Dagger  Division of Neonatology, Miami Valley Hospital, Dayton, OH; the §§ Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD; the || Department of Pediatrics, University of South Alabama Medical School, Mobile, AL; and the ¶¶ Department of Pediatrics, Northwestern University School of Medicine, Chicago, IL.

Objective.  To compare the efficacy and safety of a synthetic surfactant (Exosurf Neonatal, Burroughs Wellcome Co) and a surfactant extract of calf lung lavage (Infasurf, IND #27,169, ONY, Inc) in the prevention of neonatal respiratory distress syndrome (RDS).

Design and Setting.  Ten-center randomized masked comparison trial.

Patients.  Premature infants (n = 871) <29 weeks gestational age by best obstetric estimate.

Interventions.  Infants were randomly assigned to a course of treatment with Exosurf Neonatal (n = 438) or Infasurf (n = 433) at birth, and if still intubated, at 12 and 24 hours of age. Crossover treatment was allowed within 72 hours of age if severe respiratory failure (defined as two consecutive a/A PO2 ratios <= .10) persisted after three doses of the randomized surfactant.

Primary Outcome Measures.  Three primary outcome measures of efficacy [the incidence of RDS; the incidence of RDS death; and the incidence of survival without bronchopulmonary dysplasia at 28 days after birth] were compared using linear regression techniques.

Results.  Of 871 randomized infants, 18 infants did not receive treatment with a study surfactant, and 25 infants did not meet all eligibility criteria. The primary analysis of efficacy was performed in the 846 eligible infants and analysis of safety outcomes in the 853 infants who received study surfactant. Demographic characteristics did not differ between the two treatment groups. Compared with Exosurf, Infasurf treatment resulted in a 62% decrease in the incidence of RDS (Infasurf, 16% vs Exosurf, 42%) and a 70% decrease in RDS death (Infasurf, 1.7% vs Exosurf, 5.4%) but did not increase the incidence of survival without bronchopulmonary dysplasia at 28 days. Treatment with Infasurf resulted in significant improvement in several secondary outcome measures. Infasurf-treated infants had lower average FIO2 (Infasurf, .33 [SEM] vs Exosurf, .42; difference .08; 95% confidence interval [CI], .06 to .11) and average mean airway pressure (Infasurf, 6.0 cm H2O vs Exosurf, 7.1 cm H2O; difference 1.1 cm H2O; 95% CI, .7 to 1.6 cm H2O) for the first 72 hours of life. Crossover surfactant treatment was significantly less frequent in the Infasurf compared with the Exosurf group (Infasurf, 1% vs Exosurf, 6%). Complications (bradycardia, clinical airway obstruction, and transcutaneous arterial desaturation) associated with second and third, but not initial, surfactant treatments were observed more frequently in the Infasurf treatment group. Infasurf-treated infants had significantly less air leak (<= 7 days) (Infasurf, 8% vs Exosurf, 14%; adjusted relative risk [ARR] .55; 95% CI, .37 to .81). Severe intraventricular hemorrhage (IVH) (grade 3 and 4) did not differ between the two groups (Infasurf, 11.8% vs Exosurf, 8.3%; ARR 1.41; 95% CI, .94 to 2.09) but total IVH occurred more frequently in Infasurf-treated infants (Infasurf, 39.0% vs Exosurf, 29.9%; ARR, 1.30; 95% CI, 1.08 to 1.57).

Conclusion.  Significant reductions in the incidence of RDS, the severity of early respiratory disease, the incidence of pulmonary air leaks associated with RDS, and the mortality attributable to RDS suggest that Infasurf is a more effective surfactant preparation than Exosurf Neonatal in the prophylaxis of RDS. However, Infasurf prophylaxis as used in this study was also associated with a greater risk of total but not severe IVH.

Key words: newborn, pulmonary surfactant, randomized clinical trial, respiratory distress syndrome.




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