Effectiveness of budesonide aerosol in ventilator-dependent preterm babies: a preliminary report.
The aim of this randomized, double-blind, placebo-controlled trial was to assess the short-term effect of a topical glucocorticoid (budesonide 600 mu g twice daily) vs. placebo administered by metered dose inhaler (MDL) and spacer (Aerochamber MV15) directly into endotracheal tube of intubated infants for 7 days. Twenty preterm infants (mean birthweight, 1,030 g; mean gestational age, 27.3 weeks)who still needed assisted ventilation at 14 days of age were randomly assigned to receive budesonide (n=9) or placebo (n=11) and completed the study. The primary outcome was the need for mechanical ventilation after 7 days of treatment. Other outcome variables included ventilator settings, blood gases, serum cortisol levels, and bronchoalveolar lavage inflammatory cell counts. No ventilated infant was extubated during the study period. The treatment group showed significant improvements in mean peak inspiratory pressure, ventilator efficiency index, and (A-a) oxygen difference. There were no changes in the placebo group. Serum cortisol levels and bronchoalveolar lavage cell counts did not change significantly during study period. There was no difference in side effects between the groups. This trial demonstrates that topical budesonide administered by MDL and Aerochamber produces clinical improvement in ventilated preterm infants, without glucocorticoid side effects.
Arnon
S
S
Department of Paediatrics and Neonatal Medicine, Royal Postgraduate Medical School, Hammersmith Hospital, London, United Kingdom.
Grigg
J
J
Silverman
M
M
D000280:Administration, Inhalation; D000287:Administration, Topical; D000336:Aerosols; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001992:Bronchoalveolar Lavage Fluid / Q000166:cytology; D019819:Budesonide; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000188:drug therapy* / Q000628:therapy; D008171:Lung Diseases / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D009330:Nebulizers and Vaporizers; D010865:Pilot Projects; D011282:Pregnenediones / Q000008:administration & dosage / Q000627:therapeutic use*; D012121:Respiration, Artificial; D013997:Time Factors; D016896:Treatment Outcome
D000336:Aerosols; D000893:Anti-Inflammatory Agents; D011282:Pregnenediones; D019819:Budesonide; D006854:Hydrocortisone