Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension

NCT07099144 | Recruiting DMC

• 1 other identifier: LeesPharm
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Hypertension; Hypoxic Respiratory Failure

Outcome Measures

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).

  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.

Study Arms (1)

inhaled nitric oxide combined with ventilatory support

Drug: Inhaled nitric oxide (NO)

Interventions

Inhaled nitric oxide (NO) DRUG

The 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.

inhaled nitric oxide combined with ventilatory support

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• The neonatal guardian agrees to participate in the study and signs an informed consent form (ICF).

You may not qualify if:

• 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.
• Patient is at risk of imminent death (death expected within 24 hours).
• Life-threatening abnormality (cranial, cardiac, thoracic).
• Chromosomal abnormality.
• Congenital diaphragmatic hernia
• Congenital heart defect (other than patent ductus arteriosus or small atrial septal defect).
• Neonate has been resuscitated requiring chest compressions within 6 hours of study treatment start.
• Significant bleeding diathesis such as grade IV intraventricular hemorrhage or periventricular leukomalacia, pulmonary hemorrhage, uncontrolled bleeding or hemodynamic failure.
• Disseminated intravascular coagulopathy.
• Active seizures while receiving anticonvulsants.
• Experienced prolong asphyxia with evidence of severe acidosis (pH\<7.25)
• Receiving nitric oxide donor agents such as prilocaine, sodium nitroprusside, nitroglycerin, and sulfonamides.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Guangzhou Women and Children'S Medical Center

Guangzhou, Guangdong, 510623, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

NO and NO2 concentration，Blood gas analysis，MetHb concentration，hematology panel (MetHb, RBC, WBC, PLT), biochemistry (AST, ALT, total bilirubin, direct bilirubin, BUN, creatinine), B-type natriuretic peptide (BNP), coagulation function (aPTT, PT)

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Wen hao Zhou

CONTACT

+86-18017591123; zwhchfu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 1, 2025
• Study Start: December 12, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)