An observational study in Persistent Pulmonary Hypertension of the Newborn and Hypoxic Respiratory Failure, sponsored by Novlead Inc.. Not yet recruiting. Open to participants aged 0 Days to 30 Days. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Novlead Inc. · Observational
The goal of this prospective, multicenter, single-arm, post-market clinical study is to evaluate the performance, safety, usability, and medico-economic aspects of the INOwill-N200 device when used to deliver inhaled nitric oxide (iNO) to neonates requiring iNO therapy as part of their clinical care.
The main questions this study aims to answer are:
There is no comparison group in this study. The decision to initiate, adjust, wean, interrupt, or discontinue iNO therapy will remain under the responsibility of the treating medical team and will be based on each participant's clinical condition.
Neonates enrolled in the study will:
Healthcare professionals using the INOwill-N200 will complete the iNO Device Performance Assessment Questionnaire to evaluate device performance, usability, and overall satisfaction.
Device use and healthcare resource consumption will also be collected to estimate the total cost of iNO treatment per participant and the cost per day of therapy.
This multicenter clinical study will evaluate the INOwill-N200 nitric oxide generation and delivery system in neonates with hypoxic respiratory failure associated with pulmonary hypertension who require inhaled nitric oxide therapy.
Decisions regarding the prescribed iNO concentration, dose adjustment, weaning, interruption, and discontinuation will be made by the treating medical team according to the participant's clinical condition and the study protocol.
Technical performance will be assessed using treatment data including prescribed and delivered NO concentrations, delivered NO₂ and oxygen concentrations, the time required to reach the prescribed NO concentration, the stability of NO delivery, alarms, treatment interruptions, and device or accessory replacements. Where sufficiently detailed timestamped data are available, the percentage of valid monitored treatment time during which NO and NO₂ concentrations remain within the manufacturer-specified performance and safety ranges will be calculated centrally.
Oxygenation and ventilation parameters will be assessed at baseline, 60 minutes, 6 hours, 12 hours, 24 hours, and daily thereafter through Day 14, as applicable. Collected parameters include the Oxygenation Index, Oxygen Saturation Index, PaO₂, SpO₂, FiO₂, PaO₂/FiO₂ ratio, SpO₂/FiO₂ ratio, ventilation mode, and other protocol-defined respiratory parameters. Actual assessment dates and times will be recorded to evaluate compliance with the predefined assessment windows.
Safety surveillance will include adverse events, serious adverse events, device deficiencies, technical malfunctions, alarms, unplanned interruptions of NO delivery, and methemoglobin concentrations. The seriousness, severity, outcome, and relationship of each event to the INOwill-N200, iNO therapy, and study procedures will be assessed as defined in the protocol.
Healthcare professionals will complete the iNO Device Performance Assessment Questionnaire at baseline and on Day 14.
Device-use and healthcare-resource data will be collected to support the medico-economic evaluation. Treatment duration, generator use, accessories, consumables, replacements, staff time, and technical interventions may be combined with predefined unit costs to estimate the direct cost of iNO treatment per participant and the cost per treatment day.
40 studies on the registry are indexed under Persistent Fetal Circulation Syndrome; 6 are open to participants now.
This study's planned enrollment of 50 is below the median of 125 across 12 observational studies indexed under Persistent Fetal Circulation Syndrome.
Browse Persistent Fetal Circulation Syndrome studies →Novlead Inc. is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Newborn Babies ≥34 weeks of gestation and postnatal age \<30 days with breathing problems associated with pulmonary hypertension (high blood pressure in the lungs).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Oxygenation Index (OI) ≥20; FiO₂ requirement ≥0.60 pour avoir preductal SpO₂ >90%; PaO₂ \<60 mmHg despite optimized ventilatory support;
Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled neonates with hypoxic respiratory failure associated with pulmonary hypertension will receive inhaled nitric oxide (iNO) using the INOwill-N200 device. The prescribed iNO concentration, treatment adjustments, weaning, and discontinuation will be determined by the treating medical team according to each participant's clinical condition and the study protocol. Device performance, oxygenation response, safety, usability, and healthcare resource use will be assessed during the study period, for up to 14 days.
Device: Nitric Oxide Generator and Delivery System
INOwill N200 is a medical device designed for generation and delivery of inhaled nitric oxide (iNO) for therapeutic use in patients with pulmonary hypertension. The system integrates nitric oxide (NO) gas generation, controlled gas delivery, and real time continuous gas monitoring. It is used in conjunction with ventilatory support. The system delivers inhaled nitric oxide into the patient's breathing circuit in a way that provides a consistent, user-defined concentration to the patient throughout inspiration. It provides continuous monitoring of inspired nitric oxide (NO), nitrogen dioxide (NO2), and oxygen (O2) concentrations, supported by a comprehensive alarm system.
Evaluate the performance of the INOwill-N200 by measuring the proportion of participants achieving a reduction ≥20% in the Oxygenation Index (OI) after 60 minutes of iNO therapy compared to baseline.
OI is calculated as following: OI = (PaO2\*FiO2\*100)/PaO2
Time frame: Comparision between OI at baseline and OI after 60 minutes of iNO therapy.
To assess the clinical performance of the INOwill-N200 under real-world conditions by measuring the Oxygen Saturation Index (OSI) at predefined time points after baseline.
Description of Oxygen Saturation Index (OSI) during iNO treatment in neonates with PPHN, using continuous oxygenation metrics measured at predefined after baseline (60 min, 6 hours, 12 hours, 24 hours, and daily until treatment discontinuation or at day 14)
Time frame: Measures performed at 60 min, 6 hours, 12 hours, 24 hours, and daily until treatment discontinuation or maximum at day 14, after treatment initiation.
To assess the clinical performance of the INOwill-N200 under real-world conditions by measuring the partial pressure of oxygen in arterial blood (PaO₂) at predefined time points after baseline.
Description of the partial pressure of oxygen in arterial blood (PaO₂) during iNO treatment in neonates with PPHN, using continuous oxygenation metrics measured at predefined time points after baseline
Time frame: Measures performed at 60 min, 6 hours, 12 hours, 24 hours, and daily until treatment discontinuation or maximum at day 14, after treatment initiation.
To assess the clinical performance of the INOwill-N200 under real-world conditions by measuring the PF ratio (PaO₂/FiO₂) at predefined time points after baseline.
Description of the PF ratio (PaO₂/FiO₂) during iNO treatment in neonates with PPHN, using continuous oxygenation metrics measured at predefined time points after baseline (60 min, 6 hours, 12 hours, 24 hours, and daily until treatment discontinuation or at day 14)
Time frame: Measures performed at 60 min, 6 hours, 12 hours, 24 hours, and daily until treatment discontinuation or maximum at day 14, after treatment initiation.
To assess the clinical performance of the INOwill-N200 under real-world conditions by measuring the SF ratio (SpO₂/FiO₂) at predefined time points after baseline.
Description of the SF ratio (SpO₂/FiO₂) during iNO treatment in neonates with PPHN, using continuous oxygenation metrics measured at predefined time points after baseline (60 min, 6 hours, 12 hours, 24 hours, and daily until treatment discontinuation or at day 14)
Time frame: Up to day 14
To assess the clinical effectiveness of the INOwill-N200 by measuring the proportion of participants requiring extracorporeal membrane oxygenation (ECMO) rescue 14 days after iNO initiation
proportion of participants requiring extracorporeal membrane oxygenation (ECMO) rescue during hospitalization
Time frame: At hospital discharge
To assess the accuracy of delivered NO by comparing the concentration delivered by the device with the prescribed NO concentration during the treatment period with a maximum of 14 days
Accuracy of delivered NO concentration compared with prescribed NO concentration
Time frame: At baseline, 60 minutes, 6 hours, 24 hours after treatment initiation and at the end of inhaled nitric oxide treatment with a maximum of 14 days.
To assess the stability of NO delivery by measuring the Number of treatment interruptions during the treatment period with a maximum of 14 days
Stability of NO delivery measured by the number of treatment interruptions
Time frame: From treatment initiation until the end of iNO treatment with a maximum of 14 days.
To assess the time required to reach the prescribed NO Concentration
Time to reach the targeted iNO concentration delivered by the INOwill-N200 after treatment initiation
Time frame: From treatment initiation until the end of iNO treatment with a maximum of 14 days.
To describe any adverse events, whether related to the use of INOwill N200 T
Rate of adverse events and serious adverse events related or not to the device; Rate of device deficiencies (nature, severity, and resolution of device deficiencies) Frequency of technical malfunctions (alarm activations, unplanned interruptions, and others) of NO delivery.
Time frame: From initiation of iNO therapy through the end of the study participation (up to Day 14)
To assess the safety of the INOwill-N200 by measuring the number of participants with methemoglobinemia during the iNO treatment period in accordance with routine clinical practice at each participating site
Proportion of participants with Methemoglobin concentration ≥5%, requiring reassessment of iNO therapy
Time frame: From initiation of iNO therapy through its final discontinuation (up to Day 14).
To assess clinicians' satisfaction with the use of the INOwill N200
Overall investigator satisfaction scores based on iNO Device Performance Assessment Questionnaire
Time frame: Initiation and at the end of iNO treatment or at the end of study participation (up to Day 14)
To estimate the cost of iNO treatment per patient
Time frame: From Initiation to the end of iNO treatment or study participation (up to Day 14)
To estimate the cost per day of iNO therapy
Time frame: From Initiation to the end of iNO treatment or study participation (up to Day 14)
To estimate the mean duration of device use (hours and days)
Time frame: From Initiation to the end of iNO treatment or study participation (up to Day 14)
To estimate the Length of NICU stay (days)
Time frame: From Initiation to the end of iNO treatment or study participation (up to Day 14)
To estimate the Treatment duration
Time frame: From Initiation to the end of iNO treatment or study participation (up to Day 14)
To estimate the Number of Nitric Oxide Generators consumed per participant
Time frame: From Initiation to the end of iNO treatment or study participation (up to Day 14)
To estimate the Number of newborns receiving iNO before generator replacement
Time frame: From Initiation to the end of iNO treatment or study participation (up to Day 14)
To estimate the Time required for device preparation, installation and initiation of therapy
Time frame: From Initiation to the end of iNO treatment or study participation (up to Day 14)
To estimate the Number of device manipulation during treatment.
Time frame: From Initiation to the end of iNO treatment or study participation (up to Day 14)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be made publicly available due to participant confidentiality, data protection requirements, and the absence of a formal data-sharing plan.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Persistent Fetal Circulation Syndrome →
Novlead Inc.