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
This trial does not accept healthy volunteersQualifiers
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 population
120 neonates (gestational age ≥ 34 weeks) hypoxic respiratory failure with pulmonary hypertension. The study treatment will be administered in ventilated newborn infants expected to require support \> 24 hours, after respiratory support has been optimized. This includes optimizing tidal volume/pressures and lung recruitment (surfactant, high frequency ventilation, and positive end expiratory pressure). The administration of the study drug will be supervised by a physician investigator experienced in neonatal intensive care and used in clinics where neonatal artificial ventilation as well as rescue and resuscitation are available.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Inhaled nitric oxide (NO)
DrugThe starting dose of INOmax is 20 ppm, which is controlled by the INOmax DSIR Plus delivery system in the respiratory circuit during mechanical ventilation. The dose will be maintained at 20 ppm for 4 hours after the start of administration, then the dose can be weaned to 5 ppm provided that the arterial oxygenation is adequate, as determined by the investigator within 4-24 hours of therapy, and the therapy should be maintained at 5 ppm until the fraction of inspired oxygen (FiO2) \< 0.60. The treatment will be maintained until the potential hypoxia is resolved, or the investigator determines that the neonate no longer needs to use this drug. The maintenance treatment time is usually less than 4 days (96 hours). If the oxygenation level has not improved significantly after 4 days of maintenance treatment, the suitability of the treatment plan should be reassessed.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: inhaled nitric oxide combined with ventilatory support1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety of inhaled nitric oxide combined with ventilatory support in the treatment of neonatal (≥ 34 weeks gestational age) hypoxic respiratory failure with pulmonary hypertension.
Incidence and severity of all treatment emergent adverse events (TEAEs). Incidence of drug-related serious AEs (SAEs). Incidence of AEs of special interest (AESI).
Time frame
Adverse events that occured during the study, not more than 14 days. Blood routine, blood biochemistry, blood gas analysis, chest X-ray and echocardiography will be performed at the screening and through study completion, not more than 14 days.Sponsors and contacts
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Source ClinicalTrials.gov