دورية أكاديمية
A pilot, randomized, controlled clinical trial of lucinactant, a peptide-containing synthetic surfactant, in infants with acute hypoxemic respiratory failure
| العنوان: | A pilot, randomized, controlled clinical trial of lucinactant, a peptide-containing synthetic surfactant, in infants with acute hypoxemic respiratory failure |
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| المؤلفون: | Thomas, Neal, Guardia, Carlos, Moya, Fernando, Cheifetz, Ira, Markovitz, Barry, Cruces, Pablo, Barton, Phillip, Segal, Robert, Simmons, Phillip, Randolph, Adrienne |
| بيانات النشر: | Lippincott Williams & Wilkins |
| سنة النشر: | 2012 |
| المجموعة: | Repositorio Universidad del Desarrollo (UDD) |
| مصطلحات موضوعية: | Fatty Alcohols/therapeutic use, Hypoxia/blood, Oxygen/blood, Phosphatidylglycerols/therapeutic use, Proteins/therapeutic use, Pulmonary Surfactants/therapeutic use, Respiratory Insufficiency/blood, Respiratory Insufficiency/drug therapy |
| الوصف: | Centro de Medicina Regenerativa ; OBJECTIVE: Inhibition of surfactant function and abnormal surfactant synthesis lead to surfactant dysfunction in children with acute hypoxemic respiratory failure. We evaluated whether intratracheal lucinactant, a synthetic, peptide-containing surfactant, was safe and well-tolerated in infants with acute hypoxemic respiratory failure, and assessed its effects on clinical outcomes. METHODS AND MAIN RESULTS: Infants ≤ 2 yrs of age with acute hypoxemic respiratory failure were enrolled in a phase II, double-blind, multinational, placebo-controlled randomized trial across 36 pediatric intensive care units. Infants requiring mechanical ventilation with persistent hypoxemia meeting acute lung injury criteria were randomized to receive intratracheal lucinactant (175 mg/kg) or air placebo. One retreatment was allowed 12-24 hrs after initial dosing if hypoxemia persisted. Peri-dosing tolerability of intratracheal lucinactant and adverse experiences were assessed. Mechanical ventilation duration was analyzed using analysis of variance. The Cochran-Mantel-Haenszel test was used for categorical variables.We enrolled 165 infants (84 lucinactant; 81 placebo) with acute hypoxemic respiratory failure. There were no significant differences in baseline subject characteristics, with the exception of a lower positive end-expiratory pressure and higher tidal volume in placebo subjects. The incidence of transient peri-dosing bradycardia and desaturation was significantly higher in the lucinactant treatment group. There were no statistical differences between groups for other adverse events or mortality. Oxygenation improved in infants randomized to receive lucinactant as indicated by fewer second treatments (67% lucinactant vs. 81% placebo, p = .02) and a trend in improvement in partial pressure of oxygen in arterial blood to fraction of inspired oxygen from eligibility to 48 hrs after dose (p = .06). There was no significant reduction in duration of mechanical ventilation with lucinactant (geometric ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | Pediatr Crit Care Med. 2012 Nov;13(6):646-53; http://hdl.handle.net/11447/1363Test; http://dx.doi.org/10.1097/PCC.0b013e3182517becTest |
| DOI: | 10.1097/PCC.0b013e3182517bec |
| الإتاحة: | https://doi.org/10.1097/PCC.0b013e3182517becTest http://hdl.handle.net/11447/1363Test |
| رقم الانضمام: | edsbas.183D1BF2 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1097/PCC.0b013e3182517bec |
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