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A Randomized, Multicenter Masked Comparison Trial of Poractant Alfa (Curosurf) Versus Beractant (Survanta) in the Treatment of Respiratory Distress Syndrome in Preterm Infants

Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K and The North American Study Group
American Journal of Perinatology, Volume 21, Number 3, 109–119, 2004 (PubMed)

Design

  • Prospective, randomised, masked comparison multicentre study.

Entry criteria

  • Preterm infants 750–1750 at birth and < 35 weeks gestation.
  • Clinical and radiological signs of RDS.
  • Fraction of inspired oxygen (FiO2 = 0.30), arterial to alveolar oxygen tension ratio (a/APO2 = 0.33).

Treatment

  • Infants randomised within 6 hours of birth to one of three treatments:
    • Poractant alfa 100 mg/kg (n=96)
    • Poractant alfa 200 mg/kg (n=99)
    • Beractant 100 mg/kg (n=98)
  • Additional doses (100 mg/kg) given if mechanical ventilation still required (FiO2 = 0.30) to maintain an oxygen saturation by pulse oximetry of = 88%.
  • Second dose of surfactant (where necessary) given within 48 hours of the first.
    Repeat doses administered not less than 12 hours (poractant alfa) and 6 hours (beractant) after the previous.

Outcomes

  • Poractant alfa (100 and 200 mg/kg) significantly lowered mean FiO2 compared with beractant (100 mg/kg) at all time points until 6 hours (p<0.05) [Figure 1].
  • FiO2 AUC0-6 was significantly lower for both the poractant alfa groups compared with the beractant treatment group (p<0.005) but not different from each other.
  • Infants treated initially with poractant alfa 200 mg/kg required significantly fewer repeat doses than those receiving beractant (p < 0.002) [Figure 2].
  • In infants born at = 32 weeks’ gestation, mortality (36 weeks’ postmenstrual age)
    was significantly lower with poractant alfa 200 mg/kg than with beractant (p = 0.034) and poractant alfa 100 mg/kg (p=0.046).
  • The authors suggest that the combination of larger amounts of polar lipids and SP-B may have accounted for the faster response seen with poractant alfa compared with beractant.
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Figure 1. Poractant alfa (200 and 100 mg/kg) significantly reduced fraction of inspired oxygen (FiO2) compared to beractant at all time points until 6 hours (p < 0.05) oxygen (FiO2)
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Figure 2. Infants treated with poractant alfa (200 mg/kg) required significantly fewer repeat doses than those treated with beractant 100 mg/kg
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“Exposure to oxygen even for brief periods increases oxidative stress... clinical practice is evolving towards early extubation to non-invasive forms of ventilation to minimise lung injury. The use of a rapidly acting, low volume surfactant permits clinicians to extubate earlier removing the possibility of subsequent intratrachael dosing as well as minimising the potential for lung injury for continued mechanical ventilation.”

Three Important Advantages With Poractant Alfa

Faster weaning from supplemental oxygen

Preterm infants (<35 weeks' gestation) treated with poractant alfa (200 mg/kg initial dose) are weaned from supplemental oxygen more rapidly during the first 6 hours post-treatment than infants treated with beractant (100 mg/kg).

Less re-dosing

Significantly fewer infants required additional doses if treated with poractant alfa 200 mg/kg compared with those receiving beractant 100 mg/kg.

Survival advantage

Infants <= 32 weeks' gestation treated with 200 mg/kg poractant alfa had a survival advantage over those treated with beractant.

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