CTRI/2021/10/037536已完成3 期
A Prospective, Interventional, Randomised, Double blind, Parallel Group, Comparative Clinical study to evaluate the Efficacy & Safety of test drug, Caffeine Citrate Injection USP 20 mg/ml of Swiss Parenterals Ltd., in the comparison to reference drug, Peyona 20mg/ml of Chiesi Pharmaceuticals GmbH, Austria in the treatment of Apnea of preterm infants
Swiss Parenterals Ltd0 个研究点目标入组 51 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Post-conceptional age between 28 weeks and
- •33 weeks, and over 24 hours after birth.
- •2. At least 6 episodes of apnea (15-20 seconds
- •in duration) in 24 hours.
- •3. Signed written assent from either parent(s)
- •or legal guardian(s)
排除标准
- •1.Apnea due to: hypoxic-ischemic encephalopathy, meningitis, seizures, pneumonia which does not improve even if it treats obstructive apnea.
- •2.Blood urea nitrogen >20 mg/dL, serum creatinine >1.5 mg/dL
- •3.Serum AST or ALT >3 times the upper limit of normal.
- •4.Patients require mechanically-assisted ventilation (containing nasal CPAP)
- •5.Previous treatment with methylxanthines within 7 days prior to study enrollment.
- •6.Previous treatment with H2 antagonists (i.e., cimetidine or ranitidine) within 7 days prior to study enrollment.
- •7.Participant of other clinical trial within 6 months.
研究者
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