Pulmonary HypertensionINOFTTONHRFWPHNCT07099144
Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension
An observational study of Pulmonary Hypertension and Hypoxic Respiratory Failure, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Pulmonary Hypertension, Hypoxic Respiratory Failure
- What is being tested?
- Inhaled nitric oxide (NO)
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 16Show fewer
- 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.
- Other subjects determined by the investigator to be unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children'S Medical Center
Guangzhou, Guangdong, 510623
Wen hao Zhou, +86-18017591123, zwhchfu@126.com
About this study
Official title: A Prospective, Open, Single-arm, Multi-center Phase IV Clinical Study of Inhaled Nitric Oxide Combined With Ventilatory Support for the Treatment of Neonatal (Gestational Age ≥34 Weeks) Hypoxic Respiratory Failure With Pulmonary Hypertension.
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.
Read the detailed description
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.
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. If it is necessary to continue using this drug after evaluation by the investigator, the maximum administration time should not exceed 14 days.
Doses greater than 20 ppm are not allowed. Monitoring
- Measure methemoglobin within 4-8 hours after initiation of treatment with INOmax and periodically throughout treatment.
- Prior to INOmax treatment, appropriate procedures must be followed to purify the nitrogen dioxide (NO2) system so that the NO2 concentration should always be less than 0.5 ppm and maintained as low as possible, if NO2 is greater than 0.5 ppm, the delivery system will be assessed for failure, the NO2 analyzer will be recalibrated, and the dose and/or FiO2 will be reduced appropriately.
- Monitor for inspired NO2 during INOmax administration.
- Being tested
- Inhaled nitric oxide (NO)
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| inhaled nitric oxide combined with ventilatory support | Not described Receives: Drug: Inhaled nitric oxide (NO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start12 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099144
- Sponsor's protocol ID
- LeesPharm
- Acronym
- INOFTTONHRFWPH
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Single-arm, Multi-center Phase IV Clinical Study of Inhaled Nitric Oxide Combined With Ventilatory Support for the Treatment of Neonatal (Gestational Age ≥34 Weeks) Hypoxic Respiratory Failure With Pulmonary Hypertension.
- ClinicalTrials.gov ID
- NCT07099144
- Acronym / sponsor ID
- INOFTTONHRFWPH / LeesPharm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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. If it is necessary to continue using this drug after evaluation by the investigator, the maximum administration time should not exceed 14 days.
Doses greater than 20 ppm are not allowed. Monitoring
- Measure methemoglobin within 4-8 hours after initiation of treatment with INOmax and periodically throughout treatment.
- Prior to INOmax treatment, appropriate procedures must be followed to purify the nitrogen dioxide (NO2) system so that the NO2 concentration should always be less than 0.5 ppm and maintained as low as possible, if NO2 is greater than 0.5 ppm, the delivery system will be assessed for failure, the NO2 analyzer will be recalibrated, and the dose and/or FiO2 will be reduced appropriately.
- Monitor for inspired NO2 during INOmax administration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inhaled nitric oxide combined with ventilatory support | – | Drug: Inhaled nitric oxide (NO) |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled nitric oxide (NO)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. | Drug | inhaled nitric oxide combined with ventilatory support |
Primary outcome
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.
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.
Incidence and severity of all treatment emergent adverse events (TEAEs). Incidence of drug-related serious AEs (SAEs). Incidence of AEs of special interest (AESI).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Hypoxic Respiratory Failure, run by Lee's Pharmaceutical Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen hao Zhou (+86-18017591123, zwhchfu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.