Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 7
SponsorLee's Pharmaceutical Limited
About this trial
This is a prospective, open-label, single-arm, multicenter Phase IV clinical study to evaluate the safety of INOmax for the treatment of hypoxic respiratory failure with pulmonary hypertension in newborns (≥ 34 weeks gestational age). To evaluate the safety of INOmax combined with ventilatory support in the treatment of neonatal (≥ 34 weeks gestational age) hypoxic respiratory failure with pulmonary hypertension.
Eligibility criteria
Qualifiers
Neonates ≥ 34 weeks gestation age.
Hypoxic respiratory failure requiring more than 24 hours of ventilatory support.
Clinical or echocardiographic evidence of pulmonary hypertension (systolic pulmonary arterial pressure [sPAP] > 35 mm Hg or > 2/3 systemic blood pressure [SBP] or there is a right-to-left shunt at the atrium or arterial ductus).
Age less than 7 days at the time of treatment initiation with study drug.
Disqualifiers
Neonates dependent on right-to-left shunting of blood.
Neonates whose mother has been treated with anticoagulant therapies during pregnancy.
Echocardiography confirmed left-to-right shunt or left ventricular dysfunction.
ECMO is urgently needed, or neonate has received ECMO.
Trial design
Treatments tested in this trial
- Inhaled nitric oxide (NO)
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov