Ensaio clínico randomizado duplo cego do uso da budesonida intratraqueal com o surfactante para a prevenção da displasia broncopulmonar
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2015-08-07
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Universidade Federal de Goiás
Resumo
Despite the improvement in survival of premature infants, there was no
progress in the incidence of bronchopulmonary dysplasia, especially in the
last 20 years. Systemic corticosteroids, which has always been a therapeutic
option, fell into disuse because of its adverse effects on the neurological
development of premature infants and other routes of admistration have been
researched for use of corticosteroids. Budesonide, which is an inhaled
steroid, has been studied in an attempt to prevent bronchopulmonary
dysplasia. The objectives of this study were to determine if the intratracheal
instillation of budesonide with surfactant, improved lung performance,
prevents chronic lung disease and reduces mortality in premature infants with
minimal adverse effects. This is a clinical trial, blind and randomized 90
preterm infants who required prophylaxis or early rescue therapy with
surfactant: 45 were randomized in the treated group (0.25 mg/kg of
budesonide and 100 mg/kg surfactant) and 45 in the control group (100
mg/kg of surfactant). The evaluated final outcomes were mortality and
bronchopulmonary dysplasia. Although the treatment group has shown better
results than the control group, in both cases, mortality (10x15) and
bronchopulmonary dysplasia at 36 weeks corrected gestational age (8/35 x
10/32), there was no significant statistical difference (p = 0.501 and p =
0.571). No clinically significant adverse events were observed in the study.
The study concludes that, despite not having been demonstrated statistically
significant difference in your results, we can not rule out the benefits of
budesonide instilled into the trachea through the surfactant. Other
randomized and multicenter studies should be encouraged.
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PEIXOTO, F. A. O. Ensaio clínico randomizado duplo cego do uso da budesonida intratraqueal com o surfactante para a prevenção da displasia broncopulmonar. 2015. 56 f. Tese (Doutorado em Ciências da Saúde) - Universidade Federal de Goiás, Goiânia, 2015.