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NCT05703191
A Real-world Study of Nitric Oxide Generator and Delivery System
Conditions: Pulmonary Hypertension of Newborn
Sex: All
Ages: 34 Weeks – N/A
Enrollment: 10
Sponsor: Novlead Inc.
Summary
The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings.
Eligibility Criteria
Inclusion Criteria:Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by cliniciansTerm and near term newborns (at least 34 gestational weeks), gender unlimitedDiagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory supportDocumented Oxygenation index (OI) ≥16 prior to the treatmentSigned informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this studyExclusion Criteria:Proven risks of nitric oxide contraindicationUndergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenationOther circumstances that investigators believe unsuitable for enrollment
Source: ClinicalTrials.gov (NCT05703191). StuddyBuddy aggregates publicly available trial information.
