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Clinical Trial
. 2001 Mar;90(3):296-301.
doi: 10.1080/080352501300067631.

Early administration of the second dose of surfactant (beractant) in the treatment of severe hyaline membrane disease

Affiliations
Clinical Trial

Early administration of the second dose of surfactant (beractant) in the treatment of severe hyaline membrane disease

J Figueras-Aloy et al. Acta Paediatr. 2001 Mar.

Abstract

The aim of this study was to demonstrate that administration of the second dose of beractant 2 h after the first one is more effective than 6 h after the initial dose. The inclusion criteria for the recruitment of newborn infants were: age < or = 8 h, birthweight 600-2000 g, gestational age 23-36 wk, need for mechanical ventilation with inspiratory oxygen fraction (FiO2) > or = 0.4 and mean airway pressure (MAP) > or = 7 cmH2O to obtain arterial oxygen tension (PaO2) values between 70 and 80 mmHg, and thoracic X-ray compatible with hyaline membrane disease (HMD). Newborns with major congenital malformations, hydrops fetalis or severe pulmonary hypoplasia, or being treated with high-frequency oscillatory ventilation were excluded. In total, 57 premature newborns were studied, 20 of them below 1000 g, who received 100 mg kg-1 of beractant in 2 aliquots and showed an inadequate response, i.e. after 2 h of the first dose the newborn still needed a FiO2 > or = 0.4 and a MAP > or = 7 cmH2O to achieve a PaO2 > 70 mmHg. The second dose was randomly administered 2 or 6 h from the first one.

Conclusion: The 2 study groups were comparable except for a higher need of dopamine and seroalbumin in 2-h group. Evolution and complications were similar. Twelve hours after the first dose, the percentage improvement in the arteriolar/alveolar ratio (a/ADO2) in the 2-h group was similar to that in the 6-h group. However, in newborns below 1000 g, 12 h after the first dose the a/ADO2 percentage improvement in the 2-h group was greater than in 6-h group (median of 103.6% vs 16.3%; p = 0.035). In premature infants below 1000 g, it seems reasonable to advance the second dose of beractant if needed.

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