NL-OMON20918
Not yet recruiting
Not Applicable
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 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ACTELION Pharmaceuticals LtdGewerbestrasse 16CH-4123 AllschwilSwitzerland
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent by the parent(s) or the legal representative(s);
- •2\. Term and near\-term newborns (gestational age \> 34 weeks);
Exclusion Criteria
- •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\);
Outcomes
Primary Outcomes
Not specified
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