A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome

M. L. Hudak, E. E. Farrell, A. A. Rosenberg, A. L. Jung, R. L. Auten, D. J. Durand, M. J. Horgan, S. Buckwald, M. R. Belcastro, Pamela Kimzey Donohue, V. Carrion, W. W. Maniscalco, M. J. Balsan, B. A. Torres, R. R. Miller, R. D. Jansen, J. E. Graeber, K. M. Laskay, E. J. Matteson

Research output: Contribution to journalArticle

Abstract

Objective: To compare the efficacy and safety of two surfactant preparations in the treatment of respiratory distress syndrome (RDS). Methods: We conducted a randomized, masked comparison trial at 21 centers. Infants with RDS who were undergoing mechanical ventilation were eligible for treatment with two doses of either a synthetic (Exosurf) or natural (Infasurf) surfactant if the ratio of arterial to alveolar partial pressure of oxygen was less than or equal to 0.22. Crossover treatment was allowed within 96 hours of age if severe respiratory failure (defined as two consecutive arterial/alveolar oxygen tension ratios ≤0.10) persisted after two doses of the randomly assigned surfactant. Four primary outcome measures of efficacy (the incidence of pulmonary air leak (≤7 days); the severity of RDS; the incidence of death from RDS; and the incidence of survival without bronchopulmonary dysplasia (BPD) at 28 days after birth) were compared by means of linear regression techniques. Results: The primary analysis of efficacy was performed in 1033 eligible infants and an analysis of safety outcomes in the 1126 infants who received study surfactant. Preentry demographic characteristics and respiratory status were similar for the two treatment groups, except for a small but significant difference in mean gestational age (0.5 week) that favored the Infasurf treatment group. Pulmonary air leak (≤7 days) occurred in 21% of Exosurf- and 11% of Infasurf-treated infants (adjusted relative risk, 0.53; 95% confidence interval, 0.40 to 0.71; p ≤0.0001). During the 72 hours after the initial surfactant treatment, the average fraction of inspired oxygen (±SEM) was 0.47 ± 0.01 for Exosurf- and 0.39 ± 0.01 for Infasurf-treated infants (difference, 0.08; 95% confidence interval, 0.06 to 0.10; p 2O for Exosurf- and 7.2 ± 0.1 cm H2O for Infasurf-treated infants (difference, 1.4 cm H2O; 95% confidence interval, 1.0 to 1.8 cm H2O; P

Original languageEnglish (US)
Pages (from-to)396-406
Number of pages11
JournalJournal of Pediatrics
Volume128
Issue number3
DOIs
StatePublished - 1996
Externally publishedYes

Fingerprint

Surface-Active Agents
Confidence Intervals
Oxygen
Incidence
Therapeutics
Air
Newborn Respiratory Distress Syndrome
Safety
Bronchopulmonary Dysplasia
Lung
Partial Pressure
Artificial Respiration
Respiratory Insufficiency
Gestational Age
Linear Models
Demography
Outcome Assessment (Health Care)
calfactant
Parturition
dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Hudak, M. L., Farrell, E. E., Rosenberg, A. A., Jung, A. L., Auten, R. L., Durand, D. J., ... Matteson, E. J. (1996). A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome. Journal of Pediatrics, 128(3), 396-406. https://doi.org/10.1016/S0022-3476(96)70291-3

A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome. / Hudak, M. L.; Farrell, E. E.; Rosenberg, A. A.; Jung, A. L.; Auten, R. L.; Durand, D. J.; Horgan, M. J.; Buckwald, S.; Belcastro, M. R.; Donohue, Pamela Kimzey; Carrion, V.; Maniscalco, W. W.; Balsan, M. J.; Torres, B. A.; Miller, R. R.; Jansen, R. D.; Graeber, J. E.; Laskay, K. M.; Matteson, E. J.

In: Journal of Pediatrics, Vol. 128, No. 3, 1996, p. 396-406.

Research output: Contribution to journalArticle

Hudak, ML, Farrell, EE, Rosenberg, AA, Jung, AL, Auten, RL, Durand, DJ, Horgan, MJ, Buckwald, S, Belcastro, MR, Donohue, PK, Carrion, V, Maniscalco, WW, Balsan, MJ, Torres, BA, Miller, RR, Jansen, RD, Graeber, JE, Laskay, KM & Matteson, EJ 1996, 'A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome', Journal of Pediatrics, vol. 128, no. 3, pp. 396-406. https://doi.org/10.1016/S0022-3476(96)70291-3
Hudak, M. L. ; Farrell, E. E. ; Rosenberg, A. A. ; Jung, A. L. ; Auten, R. L. ; Durand, D. J. ; Horgan, M. J. ; Buckwald, S. ; Belcastro, M. R. ; Donohue, Pamela Kimzey ; Carrion, V. ; Maniscalco, W. W. ; Balsan, M. J. ; Torres, B. A. ; Miller, R. R. ; Jansen, R. D. ; Graeber, J. E. ; Laskay, K. M. ; Matteson, E. J. / A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome. In: Journal of Pediatrics. 1996 ; Vol. 128, No. 3. pp. 396-406.
@article{ca0a6fc6de18462ea95d74deab9a8e9f,
title = "A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome",
abstract = "Objective: To compare the efficacy and safety of two surfactant preparations in the treatment of respiratory distress syndrome (RDS). Methods: We conducted a randomized, masked comparison trial at 21 centers. Infants with RDS who were undergoing mechanical ventilation were eligible for treatment with two doses of either a synthetic (Exosurf) or natural (Infasurf) surfactant if the ratio of arterial to alveolar partial pressure of oxygen was less than or equal to 0.22. Crossover treatment was allowed within 96 hours of age if severe respiratory failure (defined as two consecutive arterial/alveolar oxygen tension ratios ≤0.10) persisted after two doses of the randomly assigned surfactant. Four primary outcome measures of efficacy (the incidence of pulmonary air leak (≤7 days); the severity of RDS; the incidence of death from RDS; and the incidence of survival without bronchopulmonary dysplasia (BPD) at 28 days after birth) were compared by means of linear regression techniques. Results: The primary analysis of efficacy was performed in 1033 eligible infants and an analysis of safety outcomes in the 1126 infants who received study surfactant. Preentry demographic characteristics and respiratory status were similar for the two treatment groups, except for a small but significant difference in mean gestational age (0.5 week) that favored the Infasurf treatment group. Pulmonary air leak (≤7 days) occurred in 21{\%} of Exosurf- and 11{\%} of Infasurf-treated infants (adjusted relative risk, 0.53; 95{\%} confidence interval, 0.40 to 0.71; p ≤0.0001). During the 72 hours after the initial surfactant treatment, the average fraction of inspired oxygen (±SEM) was 0.47 ± 0.01 for Exosurf- and 0.39 ± 0.01 for Infasurf-treated infants (difference, 0.08; 95{\%} confidence interval, 0.06 to 0.10; p 2O for Exosurf- and 7.2 ± 0.1 cm H2O for Infasurf-treated infants (difference, 1.4 cm H2O; 95{\%} confidence interval, 1.0 to 1.8 cm H2O; P",
author = "Hudak, {M. L.} and Farrell, {E. E.} and Rosenberg, {A. A.} and Jung, {A. L.} and Auten, {R. L.} and Durand, {D. J.} and Horgan, {M. J.} and S. Buckwald and Belcastro, {M. R.} and Donohue, {Pamela Kimzey} and V. Carrion and Maniscalco, {W. W.} and Balsan, {M. J.} and Torres, {B. A.} and Miller, {R. R.} and Jansen, {R. D.} and Graeber, {J. E.} and Laskay, {K. M.} and Matteson, {E. J.}",
year = "1996",
doi = "10.1016/S0022-3476(96)70291-3",
language = "English (US)",
volume = "128",
pages = "396--406",
journal = "Journal of Pediatrics",
issn = "0022-3476",
publisher = "Mosby Inc.",
number = "3",

}

TY - JOUR

T1 - A multicenter randomized, masked comparison trial of natural versus synthetic surfactant for the treatment of respiratory distress syndrome

AU - Hudak, M. L.

AU - Farrell, E. E.

AU - Rosenberg, A. A.

AU - Jung, A. L.

AU - Auten, R. L.

AU - Durand, D. J.

AU - Horgan, M. J.

AU - Buckwald, S.

AU - Belcastro, M. R.

AU - Donohue, Pamela Kimzey

AU - Carrion, V.

AU - Maniscalco, W. W.

AU - Balsan, M. J.

AU - Torres, B. A.

AU - Miller, R. R.

AU - Jansen, R. D.

AU - Graeber, J. E.

AU - Laskay, K. M.

AU - Matteson, E. J.

PY - 1996

Y1 - 1996

N2 - Objective: To compare the efficacy and safety of two surfactant preparations in the treatment of respiratory distress syndrome (RDS). Methods: We conducted a randomized, masked comparison trial at 21 centers. Infants with RDS who were undergoing mechanical ventilation were eligible for treatment with two doses of either a synthetic (Exosurf) or natural (Infasurf) surfactant if the ratio of arterial to alveolar partial pressure of oxygen was less than or equal to 0.22. Crossover treatment was allowed within 96 hours of age if severe respiratory failure (defined as two consecutive arterial/alveolar oxygen tension ratios ≤0.10) persisted after two doses of the randomly assigned surfactant. Four primary outcome measures of efficacy (the incidence of pulmonary air leak (≤7 days); the severity of RDS; the incidence of death from RDS; and the incidence of survival without bronchopulmonary dysplasia (BPD) at 28 days after birth) were compared by means of linear regression techniques. Results: The primary analysis of efficacy was performed in 1033 eligible infants and an analysis of safety outcomes in the 1126 infants who received study surfactant. Preentry demographic characteristics and respiratory status were similar for the two treatment groups, except for a small but significant difference in mean gestational age (0.5 week) that favored the Infasurf treatment group. Pulmonary air leak (≤7 days) occurred in 21% of Exosurf- and 11% of Infasurf-treated infants (adjusted relative risk, 0.53; 95% confidence interval, 0.40 to 0.71; p ≤0.0001). During the 72 hours after the initial surfactant treatment, the average fraction of inspired oxygen (±SEM) was 0.47 ± 0.01 for Exosurf- and 0.39 ± 0.01 for Infasurf-treated infants (difference, 0.08; 95% confidence interval, 0.06 to 0.10; p 2O for Exosurf- and 7.2 ± 0.1 cm H2O for Infasurf-treated infants (difference, 1.4 cm H2O; 95% confidence interval, 1.0 to 1.8 cm H2O; P

AB - Objective: To compare the efficacy and safety of two surfactant preparations in the treatment of respiratory distress syndrome (RDS). Methods: We conducted a randomized, masked comparison trial at 21 centers. Infants with RDS who were undergoing mechanical ventilation were eligible for treatment with two doses of either a synthetic (Exosurf) or natural (Infasurf) surfactant if the ratio of arterial to alveolar partial pressure of oxygen was less than or equal to 0.22. Crossover treatment was allowed within 96 hours of age if severe respiratory failure (defined as two consecutive arterial/alveolar oxygen tension ratios ≤0.10) persisted after two doses of the randomly assigned surfactant. Four primary outcome measures of efficacy (the incidence of pulmonary air leak (≤7 days); the severity of RDS; the incidence of death from RDS; and the incidence of survival without bronchopulmonary dysplasia (BPD) at 28 days after birth) were compared by means of linear regression techniques. Results: The primary analysis of efficacy was performed in 1033 eligible infants and an analysis of safety outcomes in the 1126 infants who received study surfactant. Preentry demographic characteristics and respiratory status were similar for the two treatment groups, except for a small but significant difference in mean gestational age (0.5 week) that favored the Infasurf treatment group. Pulmonary air leak (≤7 days) occurred in 21% of Exosurf- and 11% of Infasurf-treated infants (adjusted relative risk, 0.53; 95% confidence interval, 0.40 to 0.71; p ≤0.0001). During the 72 hours after the initial surfactant treatment, the average fraction of inspired oxygen (±SEM) was 0.47 ± 0.01 for Exosurf- and 0.39 ± 0.01 for Infasurf-treated infants (difference, 0.08; 95% confidence interval, 0.06 to 0.10; p 2O for Exosurf- and 7.2 ± 0.1 cm H2O for Infasurf-treated infants (difference, 1.4 cm H2O; 95% confidence interval, 1.0 to 1.8 cm H2O; P

UR - http://www.scopus.com/inward/record.url?scp=0029887649&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0029887649&partnerID=8YFLogxK

U2 - 10.1016/S0022-3476(96)70291-3

DO - 10.1016/S0022-3476(96)70291-3

M3 - Article

C2 - 8774514

AN - SCOPUS:0029887649

VL - 128

SP - 396

EP - 406

JO - Journal of Pediatrics

JF - Journal of Pediatrics

SN - 0022-3476

IS - 3

ER -