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A multicenter randomized masked comparison trial of synthetic surfactant versus calf lung surfactant extract in the prevention of neonatal respiratory distress syndrome.
MedLine Citation:
PMID:  9200358     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
M L Hudak; D J Martin; E A Egan; E J Matteson; N J Cummings; A L Jung; L V Kimberlin; R L Auten; A A Rosenberg; J M Asselin; M R Belcastro; P K Donohue; C R Hamm; R D Jansen; A S Brody; M M Riddlesberger; P Montgomery
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Pediatrics     Volume:  100     ISSN:  1098-4275     ISO Abbreviation:  Pediatrics     Publication Date:  1997 Jul 
Date Detail:
Created Date:  1997-07-21     Completed Date:  1997-07-21     Revised Date:  2014-07-29    
Medline Journal Info:
Nlm Unique ID:  0376422     Medline TA:  Pediatrics     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  39-50     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Age Factors
Bronchopulmonary Dysplasia / prevention & control
Cerebral Hemorrhage / prevention & control
Data Interpretation, Statistical
Drug Combinations
Fatty Alcohols / administration & dosage,  adverse effects,  therapeutic use*
Female
Humans
Infant, Newborn
Linear Models
Male
Phosphorylcholine*
Polyethylene Glycols / administration & dosage,  adverse effects,  therapeutic use*
Pulmonary Surfactants / administration & dosage,  adverse effects,  therapeutic use*
Respiratory Distress Syndrome, Newborn / mortality,  prevention & control*
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Drug Combinations; 0/Fatty Alcohols; 0/Polyethylene Glycols; 0/Pulmonary Surfactants; 107-73-3/Phosphorylcholine; 99732-49-7/dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination

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