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Surfactant replacement therapy in neonatal respiratory distress syndrome

A multi-centre, randomized clinical trial: comparison of high- versus low-dose of surfactant TA

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Abstract

We conducted a prospective, randomized, controlled trial comparing the efficacy of two doses of a reconstituted bovine surfactant (Surfactant TA) in premature infants requiring mechanical ventilation shortly after birth for respiratory distress syndrome. Forty-six infants weighing 1000–1499 g were randomized into two groups: a low-dose group (23 infants given a single dose of 60 mg surfactant lipid/kg) and a high-dose group (23 infants given a single dose of 120 mg/kg). The mean (SD) age at which surfactant was given was 5.5 (±1.2) h in the low-dose group and 6.0 (±1.5) h in the high dose group. Both treatments improved oxygenation (increased arterial-alvcolar PO2 ratio) with decreased mean airway pressure, the high-dose surfactant having a more beneficial effect in prolonging the response. Infants in the high-dose group had significantly less (P<0.05) incidence of both intraventricular haemorrhage and bronchopulmonary dysplasia. This prospective trial documents that a greater benefit can be obtained by increasing the dose of surfactant (120 mg/kg) beyond 60 mg/kg in the treatment of premature infants with severe respiratory distress syndrome (RDS).

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Abbreviations

RDS:

respiratory distress syndrome

Surfactant TA:

Surfactant Tokyo-Akita

5 kDa:

5 kilodaltons

ELISA:

enzyme-linked immunosorbent assay

PDA:

patent ductus arteriosus

a/APO2 :

arterial-alveolar oxygen tension ratio

MAP:

mean airway pressure

99mIc-DTPA:

99m technetium diethylenetriamine pentacetate

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Authors and Affiliations

  1. Department of Pediatrics, Iwate Medical University, 19-1 Uchimaru, 020, Morioka, Iwate, Japan

    M. Konishi & T. Fujiwara

  2. National Children's Hospital, Tokyo, Japan

    T. Naito

  3. Matsudo City Hospital, Matsudo, Japan

    Y. Takeuchi

  4. Saitama Medical Center, Kawagoe, Japan

    Y. Ogawa

  5. Seirei Hamamatsu Hospital, Hamamatsu, Japan

    K. Inukai

  6. Osaka Medical Centre for Maternal and Child Health, Osaka, Japan

    M. Fujimura

  7. Kobe University, Kobe, Japan

    H. Nakamura

  8. St. Maria Hospital, Kurume, Japan

    T. Hashimoto

Authors
  1. M. Konishi
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  2. T. Fujiwara
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  3. T. Naito
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  4. Y. Takeuchi
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  5. Y. Ogawa
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  6. K. Inukai
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  7. M. Fujimura
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  8. H. Nakamura
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  9. T. Hashimoto
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Konishi, M., Fujiwara, T., Naito, T. et al. Surfactant replacement therapy in neonatal respiratory distress syndrome. Eur J Pediatr 147, 20–25 (1988). https://doi.org/10.1007/BF00442605

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  • DOI: https://doi.org/10.1007/BF00442605

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