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

Abstract

UNLABELLED:

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.

• Authors: J Figueras-Aloy, J Quero, X Carbonell-Estrany, G Ginovart, J Pérez-Rodríguez, F Raspall, J M Rodríquez Miguélez, M D Salvía
• Journal: Acta paediatrica (Oslo, Norway : 1992) (Acta Paediatr) Vol. 90 Issue 3 Pg. 296-301 (Mar 2001) ISSN: 0803-5253 [Print] Norway
• PMID: 11332171 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Biological Products
• Pulmonary Surfactants
• beractant

Topics

• Biological Products
• Female
• Humans
• Hyaline Membrane Disease (drug therapy)
• Infant, Newborn
• Infant, Premature
• Male
• Prospective Studies
• Pulmonary Surfactants (administration & dosage, therapeutic use)