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临床试验/NL-OMON20918
NL-OMON20918尚未招募不适用

Multicenter, double-blind, placebo-controlled, randomized, prospective study of bosentan as adjunctive therapy to inhaled nitric oxide in the management of persistent pulmonary hypertension of the newborn (PPHN).

ACTELION Pharmaceuticals LtdGewerbestrasse 16CH-4123 AllschwilSwitzerland0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30

研究概览

简要总结

/A

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Signed informed consent by the parent(s) or the legal representative(s);
  • 2. Term and near-term newborns (gestational age > 34 weeks);

排除标准

  • 1. PH associated with conditions other than PPHN;
  • 2. Immediate need for cardiac resuscitation or extracorporeal membrane oxygenation (ECMO) (profound hypoxemia [PaO2] < 30 mm Hg; OI > 40);

研究者

发起方
ACTELION Pharmaceuticals LtdGewerbestrasse 16CH-4123 AllschwilSwitzerland

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Pediatric Formulation of bosentan in pulmonary... | 临床试验