Persistent Pulmonary Hypertension of the NewbornNCT06832163
Close Loop Smart Weaning for INO With PPHN
A study testing Nitric Oxide Generation and Delivery System in people with Persistent Pulmonary Hypertension of the Newborn and Inhaled Nitric Oxide, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
In contemporary clinical practice concerning the administration of inhaled nitric oxide (iNO) within neonatal intensive care units (NICUs), a stepwise reduction approach is frequently employed in accordance with established neonatal guidelines. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Persistent Pulmonary Hypertension of the Newborn, Inhaled Nitric Oxide
- What is being tested?
- Nitric Oxide Generation and Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The administration of inhaled nitric oxide (iNO) has commenced or is anticipated to commence for a duration of 24 hours or more, based on a clinical diagnosis of persistent pulmonary hypertension of the newborn (PPHN);
- There is a demonstrable positive response to iNO treatment;
- The iNO delivery system employed is appropriate and meets the conditional requirements, featuring an intelligent closed-loop offline functionality;
- The guardian or legal representative possesses a comprehensive understanding of the potential benefits and risks associated with participation in this study and has expressed a willingness to consent by signing the informed consent document.
Who cannot join
- There are established contraindications associated with the use of nitric oxide, which include the following conditions:
- Severe hypoplasia of the left heart or duct-dependent congenital heart disease;
- Life-threatening congenital anomalies and congestive heart failure;
- Congenital methemoglobinemia;
- Significant hemorrhagic events, such as intracranial hemorrhage, intraventricular hemorrhage, and pulmonary hemorrhage.
- Patients with chronic pulmonary conditions and other refractory diseases are not permitted to initiate withdrawal from the inhaled nitric oxide (iNO) treatment within a seven-day period following its administration.
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- In cases where there is no observable response to iNO or if the duration of use is less than 30 minutes, a strict tapering protocol for withdrawal is not required.
- If the concentration of iNO treatment exceeds 20 parts per million (ppm) during the initiation phase or if the starting concentration for withdrawal is below 20 ppm, specific considerations must be taken into account.
- Participation in concurrent clinical trials involving other pharmacological agents or medical devices is prohibited.
- The investigator may determine that participation in this study is not appropriate for certain individuals.
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
Children's Hospital of Fudan University
Shanghai
Lin Yuan, +86 13817919048, drlynnyuan@fudan.edu.cn
About this study
Official title: Close Loop Smart Weaning Protocol for Inhaled Nitric Oxide Therapy With PPHN
In contemporary clinical practice concerning the administration of inhaled nitric oxide (iNO) within neonatal intensive care units (NICUs), a stepwise reduction approach is frequently employed in accordance with established neonatal guidelines. Nonetheless, the comparative advantages of a linear reduction strategy-characterized by a gradual decrease in inhalation concentration-over the traditional stepwise method in terms of efficacy and safety have yet to be conclusively established. Furthermore, existing iNO delivery devices necessitate that healthcare professionals manually adjust parameters at intervals dictated by the patient's condition. This reliance on subjective clinical judgment often results in variability and a lack of standardization in the duration of the weaning process. Additionally, the protracted and intricate nature of the weaning procedure considerably heightens the workload for healthcare staff. Importantly, the development of a scientifically grounded, standardized, and real-time feedback mechanism for weaning may enhance clinical outcomes for patients and mitigate the risks associated with inappropriate weaning practices or inconsistent manual interventions. Consequently, this study seeks to leverage the newly introduced "intelligent closed-loop weaning" feature of the latest generation of iNO devices to facilitate automated linear concentration reduction during the weaning process. This innovation aims to alleviate the burden on healthcare personnel while establishing a more standardized and scientifically robust weaning protocol. However, it is noteworthy that there is currently a lack of clinical evidence, both domestically and internationally, regarding the safety and efficacy of this device's weaning protocol, underscoring the urgent need to validate its safety and effectiveness in real-world clinical settings.
- Being tested
- Nitric Oxide Generation and Delivery System
- Keywords
- Inhaled Nitric Oxide, Persistent Pulmonary Hypertension of the Newborn
- Medical subject headings
- Persistent Fetal Circulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide Generation and Delivery SystemDevice
The Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath.
iNO devices with intelligent closed-loop offline function are required to meet the import and discharge standards. The initial concentration of NO withdrawal is 20ppm. In accordance with the withdrawal criteria outlined in the Chinese Guidelines, it is essential to conduct a comprehensive efficacy evaluation prior to initiating withdrawal. Furthermore, the process of inhaled nitric oxide (iNO) evacuation should commence only if specific conditions are satisfied.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide (iNO), the initial concentration of NO withdrawal is 20ppm. | Experimental | In the initial phase of the study, a total of 10 participants are enrolled in a non-controlled single-group pre-trial.
The subsequent phase is organized into two distinct groups, each comprising 10 participants, resulting in a total of 20 subjects. The groups are categorized as follows:
① The experimental group, which utilizes an intelligent closed-loop offline system operating in a linear decline mode;
② The control group, which employs an intelligent closed-loop offline system functioning in a step decline mode. Receives: Device: Nitric Oxide Generation and Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of nitric oxide (NO) rebound hypoxia during the evacuation process
The occurrence of nitric oxide (NO) rebound hypoxia during the evacuation process, operationally defined as the frequency of instances in which peripheral capillary oxygen saturation (SpO2) decreased by more than 5% and the fraction of inspired oxygen (FiO2) increased by 15% in order to maintain partial pressure of arterial oxygen (PaO2) above 60 mmHg (with SpO2 ≥ 90%) during the evacuation of NO
Measured: Completion of evacuation (expected day 2 of evacuation)
The total duration of inhaled nitric oxide (iNO) evacuation
The entire length of time required to remove or discontinue the use of iNO.
Measured: Completion of evacuation (expected day 2 of evacuation)
Secondary outcomes (8)
Device Alarm Frequency
The frequency of device alarms recorded during the evacuation process.
Measured: Completion of evacuation (expected day 2 of evacuation)
NO Concentration Adjustments
The total number of adjustments made to knobs and settings for nitric oxide concentration during evacuation.
Measured: Completion of evacuation (expected day 2 of evacuation)
Mechanical Ventilation Duration
The duration of mechanical ventilation.
Measured: Completion of evacuation (expected day 2 of evacuation)
Adverse Events Incidence
The incidence of adverse events associated with nitric oxide treatment.
Measured: Completion of evacuation (expected day 2 of evacuation)
Complication Rate
The complication rate, specifically focusing on Grade 3-4 intraventricular hemorrhage, intraventricular plasmalacia, moderate to severe bronchopulmonary dysplasia, retinopathy of prematurity necessitating intervention, patent ductus arteriosus requiring either medical or surgical management, pulmonary hemorrhage, and air leak syndrome.
Measured: Completion of evacuation (expected day 2 of evacuation)
ECMO Utilization Rate
The proportion of cases that required extracorporeal membrane oxygenation (ECMO).
Measured: Completion of evacuation (expected day 2 of evacuation)
Mortality Rate Before Discharge
The mortality rate prior to discharge.
Measured: Completion of evacuation (expected day 2 of evacuation)
Healthcare Utilization Preferences
Scores obtained from questionnaires assessing preferences for healthcare utilization.The Likert Scale is used in the questionnaires to measure respondents' attitudes, preferences, or perceptions. It typically ranges from 1 to 5 points, where 1 represents "Strongly Disagree" and 5 represents "Strongly Agree". Respondents select the level that best reflects their opinion, allowing researchers to quantify subjective data and analyze trends effectively.
Measured: Completion of evacuation (expected day 2 of evacuation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Pulmonary Hypertension of the NewbornStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- In the initial phase of the study, a total of 10 participants are enrolled in a non-controlled single-group pre-trial. The subsequent phase is organized into two distinct groups, each comprising 10 participants, resulting in a total of 20 subjects. The groups are categorized as follows: ① The experimental group, which utilizes an intelligent closed-loop offline system operating in a linear decline mode; ② The control group, which employs an intelligent closed-loop offline system functioning in a step decline mode.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Yuan, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832163
- Sponsor's protocol ID
- Close-iNO Study
- Status last verified
- May 2026
- First submitted
- 12 Feb 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Close Loop Smart Weaning Protocol for Inhaled Nitric Oxide Therapy With PPHN
- ClinicalTrials.gov ID
- NCT06832163
- Acronym / sponsor ID
- Close-iNO Study
- Keywords
- Inhaled Nitric Oxide, Persistent Pulmonary Hypertension of the Newborn
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 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.
In contemporary clinical practice concerning the administration of inhaled nitric oxide (iNO) within neonatal intensive care units (NICUs), a stepwise reduction approach is frequently employed in accordance with established neonatal guidelines. Nonetheless, the comparative advantages of a linear reduction strategy-characterized by a gradual decrease in inhalation concentration-over the traditional stepwise method in terms of efficacy and safety have yet to be conclusively established. Furthermore, existing iNO delivery devices necessitate that healthcare professionals manually adjust parameters at intervals dictated by the patient's condition. This reliance on subjective clinical judgment often results in variability and a lack of standardization in the duration of the weaning process. Additionally, the protracted and intricate nature of the weaning procedure considerably heightens the workload for healthcare staff. Importantly, the development of a scientifically grounded, standardized, and real-time feedback mechanism for weaning may enhance clinical outcomes for patients and mitigate the risks associated with inappropriate weaning practices or inconsistent manual interventions. Consequently, this study seeks to leverage the newly introduced "intelligent closed-loop weaning" feature of the latest generation of iNO devices to facilitate automated linear concentration reduction during the weaning process. This innovation aims to alleviate the burden on healthcare personnel while establishing a more standardized and scientifically robust weaning protocol. However, it is noteworthy that there is currently a lack of clinical evidence, both domestically and internationally, regarding the safety and efficacy of this device's weaning protocol, underscoring the urgent need to validate its safety and effectiveness in real-world clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In the initial phase of the study, a total of 10 participants are enrolled in a non-controlled single-group pre-trial. The subsequent phase is organized into two distinct groups, each comprising 10 participants, resulting in a total of 20 subjects. The groups are categorized as follows: ① The experimental group, which utilizes an intelligent closed-loop offline system operating in a linear decline mode; ② The control group, which employs an intelligent closed-loop offline system functioning in a step decline mode.
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxide (iNO), the initial concentration of NO withdrawal is 20ppm. | Experimental | Device: Nitric Oxide Generation and Delivery SystemIn the initial phase of the study, a total of 10 participants are enrolled in a non-controlled single-group pre-trial. The subsequent phase is organized into two distinct groups, each comprising 10 participants, resulting in a total of 20 subjects. The groups are categorized as follows: ① The experimental group, which utilizes an intelligent closed-loop offline system operating in a linear decline mode; ② The control group, which employs an intelligent closed-loop offline system functioning in a step decline mode. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The administration of inhaled nitric oxide (iNO) has commenced or is anticipated to commence for a duration of 24 hours or more, based on a clinical diagnosis of persistent pulmonary hypertension of the newborn (PPHN);
- There is a demonstrable positive response to iNO treatment;
- The iNO delivery system employed is appropriate and meets the conditional requirements, featuring an intelligent closed-loop offline functionality;
- The guardian or legal representative possesses a comprehensive understanding of the potential benefits and risks associated with participation in this study and has expressed a willingness to consent by signing the informed consent document.
Key exclusion criteria (10 listed)
- There are established contraindications associated with the use of nitric oxide, which include the following conditions:
- Patients with chronic pulmonary conditions and other refractory diseases are not permitted to initiate withdrawal from the inhaled nitric oxide (iNO) treatment within a seven-day period following its administration.
- In cases where there is no observable response to iNO or if the duration of use is less than 30 minutes, a strict tapering protocol for withdrawal is not required.
- If the concentration of iNO treatment exceeds 20 parts per million (ppm) during the initiation phase or if the starting concentration for withdrawal is below 20 ppm, specific considerations must be taken into account.
- Participation in concurrent clinical trials involving other pharmacological agents or medical devices is prohibited.
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 |
|---|---|---|
| Nitric Oxide Generation and Delivery SystemThe Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. iNO devices with intelligent closed-loop offline function are required to meet the import and discharge standards. The initial concentration of NO withdrawal is 20ppm. In accordance with the withdrawal criteria outlined in the Chinese Guidelines, it is essential to conduct a comprehensive efficacy evaluation prior to initiating withdrawal. Furthermore, the process of inhaled nitric oxide (iNO) evacuation should commence only if specific conditions are satisfied. | Device | Inhaled Nitric Oxide (iNO), the initial concentration of NO withdrawal is 20ppm. |
Primary outcome
The occurrence of nitric oxide (NO) rebound hypoxia during the evacuation process
Time frame: Completion of evacuation (expected day 2 of evacuation)
The occurrence of nitric oxide (NO) rebound hypoxia during the evacuation process, operationally defined as the frequency of instances in which peripheral capillary oxygen saturation (SpO2) decreased by more than 5% and the fraction of inspired oxygen (FiO2) increased by 15% in order to maintain partial pressure of arterial oxygen (PaO2) above 60 mmHg (with SpO2 ≥ 90%) during the evacuation of NO
The total duration of inhaled nitric oxide (iNO) evacuation
Time frame: Completion of evacuation (expected day 2 of evacuation)
The entire length of time required to remove or discontinue the use of iNO.
8 secondary outcomes
Device Alarm Frequency
Time frame: Completion of evacuation (expected day 2 of evacuation)
NO Concentration Adjustments
Time frame: Completion of evacuation (expected day 2 of evacuation)
Mechanical Ventilation Duration
Time frame: Completion of evacuation (expected day 2 of evacuation)
Adverse Events Incidence
Time frame: Completion of evacuation (expected day 2 of evacuation)
Complication Rate
Time frame: Completion of evacuation (expected day 2 of evacuation)
ECMO Utilization Rate
Time frame: Completion of evacuation (expected day 2 of evacuation)
Mortality Rate Before Discharge
Time frame: Completion of evacuation (expected day 2 of evacuation)
Healthcare Utilization Preferences
Time frame: Completion of evacuation (expected day 2 of evacuation)
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 13 May 2026.
- 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.
Lin Yuan principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitric Oxide Generation and Delivery System in people with Persistent Pulmonary Hypertension of the Newborn and Inhaled Nitric Oxide, run by Children's Hospital of Fudan University 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 4 inclusion and 10 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 13 May 2026. 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 Zhicheng Zhu (+86 13601911685, jonney116@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of nitric oxide (NO) rebound hypoxia during the evacuation process (time frame: Completion of evacuation (expected day 2 of evacuation)). The study lists 2 primary outcomes in all. 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 13 May 2026.