EUCTR2005-000489-37-CZ进行中（未招募）不适用
An open label, randomized, controlled study to evaluate the safety and efficacy of aerosolized surfactant, Curosurf®, delivered via nasal continuous positive airway pressure pulmonary drug delivery system (NCPAP PDDS) in infants with respiratory distress syndrome.
ektar Therapeutics0 个研究点目标入组 20 人开始时间: 2005年8月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are eligible to participate in the study:
- •1.RDS by clinical and radiographic criteria
- •2.Birth weight between and including 750 to 1000 g if gestional age (GA) = 27 weeks, and between 1001 to 2500 g (no restrictions on GA)
- •3.Post-natal age of 2 to 4h
- •4.On NCPAP with FiO2 of 0.3-0.35 to maintain SaO2 87-93% for = 30 min preceding randomization
- •5.Arterial line in place
- •6.At least one ABG obtained while on NCPAP with FiO2 of 0.3-0.35 to maintain SaO2 87-93% during the hour prior to randomization
- •7.Written informed consent obtained from parent or legal guardian prior to enrollment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who meet any of the following criteria are not eligible to participate in the study:
- •1.Rupture of membranes > 6 days prior to delivery
- •2.Prior surfactant treatment
- •3.Any post-natal ABG with pH<7.20
- •4.Any ABG obtained =1h prior to randomization with pH<7.23
- •5.Pneumothorax, including pneumonthorax which has been successfully evacuated
- •6.Apgar score = 3 at 5min post-natal age
- •7.Major congenital anomalies (e.g. CHD, myelomeningocele)
- •8.Congenital heart disease (does not include patent ductus arteriosus, patent foramen ovale or small ventricular defect)
- •9.Requiring >10 µg/kg/min dopamine to maintain acceptable blood pressure during the hour prior to randomization
- •10.Other medical problem that would potentially interfere with the conduct of the study or confound study endpoints
- •11.Previously received or are planned to receive any other experimental treatment during the study period
研究者
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