Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure

A. Lotze, B. R. Mitchell, D. I. Bulas, E. M. Zola, R. A. Shalwitz, J. H. Gunkel, H. Feick, J. Fasules, M. Magoon, T. Weber, K. Van Meurs, L. Salter, A. Thompson, A. Lotze, S. Pearlman, M. Rodriguez, D. Hsiao, R. Miller, J. McGowan, G. WaterkotteF. Murphey, R. Baker, B. Patel, M. Keszler, J. Ferlauto, W. Engle, D. Stewart, J. Bhatia, W. Kanto, K. B. Al-Mateen, D. Purohit, C. Dothey, M. Fernandes, J. Gerdes, M. Shwer, E. Stork, D. Marsh, J. Gonzalez, M. Maurer, D. Sprague, G. Knight, P. Riedel, L. Parton, M. Antunes, E. Rider, D. J. Rawlings, W. Drummond, D. Kays, S. Denson, J. Sparks, S. Keeney, S. St. Charles, R. Cicco

Research output: Contribution to journalArticle

249 Citations (Scopus)

Abstract

Objective: The purpose of this study was to determine whether surfactant (beractant) administration to term newborns in respiratory failure and at risk for requiring extracorporeal membrane oxygenation (ECMO) treatment would significantly reduce the incidence of severe complications through 28 days of age and the need for ECMO. Study design: A multicenter (n = 44), randomized, double-blind, placebo-controlled trial was conducted. Infants weighing 2000 gm or more with gestational ages of 36 weeks or greater were stratified by diagnosis (meconium aspiration syndrome, sepsis, or idiopathic persistent pulmonary hypertension of the newborn) and oxygenation index (15 to 22, 23 to 30, 31 to 39) and then randomly assigned to receive four doses of beractant, 100 mg/kg (n = 167), or air placebo (n = 161) before ECMO treatment and four additional doses during ECMO, if ECMO was required. The incidence of untoward effects (including hemorrhagic, neurologic, pulmonary, renal, cardiovascular, infectious, metabolic, and technical complications) occurring before and after randomization and through 28 days of age or discharge were recorded. Results: The two treatment groups were comparable in baseline parameters, including birth weight, sex, gestational age, oxygenation index, and primary diagnosis. There was no difference in the incidence of severe complications. The need for ECMO therapy was significantly less in the surfactant group than in the placebo group (p = 0.038); this effect was greatest within the lowest oxygenation index stratum (15 to 22; p = 0.013). Conclusions: Use of surfactant, particularly in the early phase of respiratory failure, significantly decreases the need for ECMO in the treatment of term newborns with respiratory failure, without increasing the risk of complications.

Original languageEnglish (US)
Pages (from-to)40-47
Number of pages8
JournalJournal of Pediatrics
Volume132
Issue number1
DOIs
StatePublished - Jan 1 1998
Externally publishedYes

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Extracorporeal Membrane Oxygenation
Surface-Active Agents
Respiratory Insufficiency
Multicenter Studies
Placebos
Therapeutics
Gestational Age
Incidence
Persistent Fetal Circulation Syndrome
Meconium Aspiration Syndrome
Newborn Infant
Random Allocation
beractant
Birth Weight
Nervous System
Sepsis
Air
Kidney
Lung

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Lotze, A., Mitchell, B. R., Bulas, D. I., Zola, E. M., Shalwitz, R. A., Gunkel, J. H., ... Cicco, R. (1998). Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure. Journal of Pediatrics, 132(1), 40-47. https://doi.org/10.1016/S0022-3476(98)70482-2

Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure. / Lotze, A.; Mitchell, B. R.; Bulas, D. I.; Zola, E. M.; Shalwitz, R. A.; Gunkel, J. H.; Feick, H.; Fasules, J.; Magoon, M.; Weber, T.; Van Meurs, K.; Salter, L.; Thompson, A.; Lotze, A.; Pearlman, S.; Rodriguez, M.; Hsiao, D.; Miller, R.; McGowan, J.; Waterkotte, G.; Murphey, F.; Baker, R.; Patel, B.; Keszler, M.; Ferlauto, J.; Engle, W.; Stewart, D.; Bhatia, J.; Kanto, W.; Al-Mateen, K. B.; Purohit, D.; Dothey, C.; Fernandes, M.; Gerdes, J.; Shwer, M.; Stork, E.; Marsh, D.; Gonzalez, J.; Maurer, M.; Sprague, D.; Knight, G.; Riedel, P.; Parton, L.; Antunes, M.; Rider, E.; Rawlings, D. J.; Drummond, W.; Kays, D.; Denson, S.; Sparks, J.; Keeney, S.; St. Charles, S.; Cicco, R.

In: Journal of Pediatrics, Vol. 132, No. 1, 01.01.1998, p. 40-47.

Research output: Contribution to journalArticle

Lotze, A, Mitchell, BR, Bulas, DI, Zola, EM, Shalwitz, RA, Gunkel, JH, Feick, H, Fasules, J, Magoon, M, Weber, T, Van Meurs, K, Salter, L, Thompson, A, Lotze, A, Pearlman, S, Rodriguez, M, Hsiao, D, Miller, R, McGowan, J, Waterkotte, G, Murphey, F, Baker, R, Patel, B, Keszler, M, Ferlauto, J, Engle, W, Stewart, D, Bhatia, J, Kanto, W, Al-Mateen, KB, Purohit, D, Dothey, C, Fernandes, M, Gerdes, J, Shwer, M, Stork, E, Marsh, D, Gonzalez, J, Maurer, M, Sprague, D, Knight, G, Riedel, P, Parton, L, Antunes, M, Rider, E, Rawlings, DJ, Drummond, W, Kays, D, Denson, S, Sparks, J, Keeney, S, St. Charles, S & Cicco, R 1998, 'Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure', Journal of Pediatrics, vol. 132, no. 1, pp. 40-47. https://doi.org/10.1016/S0022-3476(98)70482-2
Lotze, A. ; Mitchell, B. R. ; Bulas, D. I. ; Zola, E. M. ; Shalwitz, R. A. ; Gunkel, J. H. ; Feick, H. ; Fasules, J. ; Magoon, M. ; Weber, T. ; Van Meurs, K. ; Salter, L. ; Thompson, A. ; Lotze, A. ; Pearlman, S. ; Rodriguez, M. ; Hsiao, D. ; Miller, R. ; McGowan, J. ; Waterkotte, G. ; Murphey, F. ; Baker, R. ; Patel, B. ; Keszler, M. ; Ferlauto, J. ; Engle, W. ; Stewart, D. ; Bhatia, J. ; Kanto, W. ; Al-Mateen, K. B. ; Purohit, D. ; Dothey, C. ; Fernandes, M. ; Gerdes, J. ; Shwer, M. ; Stork, E. ; Marsh, D. ; Gonzalez, J. ; Maurer, M. ; Sprague, D. ; Knight, G. ; Riedel, P. ; Parton, L. ; Antunes, M. ; Rider, E. ; Rawlings, D. J. ; Drummond, W. ; Kays, D. ; Denson, S. ; Sparks, J. ; Keeney, S. ; St. Charles, S. ; Cicco, R. / Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure. In: Journal of Pediatrics. 1998 ; Vol. 132, No. 1. pp. 40-47.
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abstract = "Objective: The purpose of this study was to determine whether surfactant (beractant) administration to term newborns in respiratory failure and at risk for requiring extracorporeal membrane oxygenation (ECMO) treatment would significantly reduce the incidence of severe complications through 28 days of age and the need for ECMO. Study design: A multicenter (n = 44), randomized, double-blind, placebo-controlled trial was conducted. Infants weighing 2000 gm or more with gestational ages of 36 weeks or greater were stratified by diagnosis (meconium aspiration syndrome, sepsis, or idiopathic persistent pulmonary hypertension of the newborn) and oxygenation index (15 to 22, 23 to 30, 31 to 39) and then randomly assigned to receive four doses of beractant, 100 mg/kg (n = 167), or air placebo (n = 161) before ECMO treatment and four additional doses during ECMO, if ECMO was required. The incidence of untoward effects (including hemorrhagic, neurologic, pulmonary, renal, cardiovascular, infectious, metabolic, and technical complications) occurring before and after randomization and through 28 days of age or discharge were recorded. Results: The two treatment groups were comparable in baseline parameters, including birth weight, sex, gestational age, oxygenation index, and primary diagnosis. There was no difference in the incidence of severe complications. The need for ECMO therapy was significantly less in the surfactant group than in the placebo group (p = 0.038); this effect was greatest within the lowest oxygenation index stratum (15 to 22; p = 0.013). Conclusions: Use of surfactant, particularly in the early phase of respiratory failure, significantly decreases the need for ECMO in the treatment of term newborns with respiratory failure, without increasing the risk of complications.",
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T1 - Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure

AU - Lotze, A.

AU - Mitchell, B. R.

AU - Bulas, D. I.

AU - Zola, E. M.

AU - Shalwitz, R. A.

AU - Gunkel, J. H.

AU - Feick, H.

AU - Fasules, J.

AU - Magoon, M.

AU - Weber, T.

AU - Van Meurs, K.

AU - Salter, L.

AU - Thompson, A.

AU - Lotze, A.

AU - Pearlman, S.

AU - Rodriguez, M.

AU - Hsiao, D.

AU - Miller, R.

AU - McGowan, J.

AU - Waterkotte, G.

AU - Murphey, F.

AU - Baker, R.

AU - Patel, B.

AU - Keszler, M.

AU - Ferlauto, J.

AU - Engle, W.

AU - Stewart, D.

AU - Bhatia, J.

AU - Kanto, W.

AU - Al-Mateen, K. B.

AU - Purohit, D.

AU - Dothey, C.

AU - Fernandes, M.

AU - Gerdes, J.

AU - Shwer, M.

AU - Stork, E.

AU - Marsh, D.

AU - Gonzalez, J.

AU - Maurer, M.

AU - Sprague, D.

AU - Knight, G.

AU - Riedel, P.

AU - Parton, L.

AU - Antunes, M.

AU - Rider, E.

AU - Rawlings, D. J.

AU - Drummond, W.

AU - Kays, D.

AU - Denson, S.

AU - Sparks, J.

AU - Keeney, S.

AU - St. Charles, S.

AU - Cicco, R.

PY - 1998/1/1

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N2 - Objective: The purpose of this study was to determine whether surfactant (beractant) administration to term newborns in respiratory failure and at risk for requiring extracorporeal membrane oxygenation (ECMO) treatment would significantly reduce the incidence of severe complications through 28 days of age and the need for ECMO. Study design: A multicenter (n = 44), randomized, double-blind, placebo-controlled trial was conducted. Infants weighing 2000 gm or more with gestational ages of 36 weeks or greater were stratified by diagnosis (meconium aspiration syndrome, sepsis, or idiopathic persistent pulmonary hypertension of the newborn) and oxygenation index (15 to 22, 23 to 30, 31 to 39) and then randomly assigned to receive four doses of beractant, 100 mg/kg (n = 167), or air placebo (n = 161) before ECMO treatment and four additional doses during ECMO, if ECMO was required. The incidence of untoward effects (including hemorrhagic, neurologic, pulmonary, renal, cardiovascular, infectious, metabolic, and technical complications) occurring before and after randomization and through 28 days of age or discharge were recorded. Results: The two treatment groups were comparable in baseline parameters, including birth weight, sex, gestational age, oxygenation index, and primary diagnosis. There was no difference in the incidence of severe complications. The need for ECMO therapy was significantly less in the surfactant group than in the placebo group (p = 0.038); this effect was greatest within the lowest oxygenation index stratum (15 to 22; p = 0.013). Conclusions: Use of surfactant, particularly in the early phase of respiratory failure, significantly decreases the need for ECMO in the treatment of term newborns with respiratory failure, without increasing the risk of complications.

AB - Objective: The purpose of this study was to determine whether surfactant (beractant) administration to term newborns in respiratory failure and at risk for requiring extracorporeal membrane oxygenation (ECMO) treatment would significantly reduce the incidence of severe complications through 28 days of age and the need for ECMO. Study design: A multicenter (n = 44), randomized, double-blind, placebo-controlled trial was conducted. Infants weighing 2000 gm or more with gestational ages of 36 weeks or greater were stratified by diagnosis (meconium aspiration syndrome, sepsis, or idiopathic persistent pulmonary hypertension of the newborn) and oxygenation index (15 to 22, 23 to 30, 31 to 39) and then randomly assigned to receive four doses of beractant, 100 mg/kg (n = 167), or air placebo (n = 161) before ECMO treatment and four additional doses during ECMO, if ECMO was required. The incidence of untoward effects (including hemorrhagic, neurologic, pulmonary, renal, cardiovascular, infectious, metabolic, and technical complications) occurring before and after randomization and through 28 days of age or discharge were recorded. Results: The two treatment groups were comparable in baseline parameters, including birth weight, sex, gestational age, oxygenation index, and primary diagnosis. There was no difference in the incidence of severe complications. The need for ECMO therapy was significantly less in the surfactant group than in the placebo group (p = 0.038); this effect was greatest within the lowest oxygenation index stratum (15 to 22; p = 0.013). Conclusions: Use of surfactant, particularly in the early phase of respiratory failure, significantly decreases the need for ECMO in the treatment of term newborns with respiratory failure, without increasing the risk of complications.

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