RBR-96kvrq招募中2 期
Phase II, randomized, placebo-controlled, double-blind clinical trial to evaluate the effects and safety of infusion of low-doses of Methilprednisolone in early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) in children - PEDALI: PEDALI
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 29D 至 18Y（—）
入选标准
- •Pediatric patients in mechanical ventilation; diagnosis of ALI/ARDS within the first 72 hours based on the current literature criteria; informed consent properly signed; both genders; age range from 29 days to 18 years.
排除标准
- •ALI/ARDS with more than 72 hours of diagnosis; failure to obtain written informed consent to participate in the study; condition requiring > 0.5mg/Kg/day of prednisone equivalent; primary or secondary neuromuscular dysfunction; patients using aminoglycosides combined with neuromuscular blockers; cardiopulmonary arrest within 7 days or anytime during present hospitalization prior to enrollment; irreversible cessation of all brain function; immunosuppression acquired or congenital, including HIV+ status; history of bone marrow or solid organ transplantation; current malignancy, neutropenia, receiving cytotoxic therapy for any reason, and acute burn injury; severe chronic liver disease
研究者
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