Smart machine takes over weaning of lung medicine for sick newborns
NCT ID NCT06832163
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new smart device that automatically lowers the dose of inhaled nitric oxide in newborns with persistent pulmonary hypertension. The device aims to make the weaning process safer and more consistent by using a gradual, real-time reduction instead of manual step changes. Thirty infants whose families agree to participate will be enrolled to see if the smart weaning reduces oxygen drops and shortens treatment time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inhaled nitric oxide delivered via a smart closed-loop device
- What this could lead to
- If successful, this could establish a safer, more standardized way to wean newborns off inhaled nitric oxide, reducing manual errors and staff workload.
- What could go wrong
- This is a small, early-stage study with only 30 participants, and the smart weaning feature has not been tested clinically before. It may not show clear benefits over current methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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); 2. There is a demonstrable positive response to iNO treatment; 3. The iNO delivery system employed is appropriate and meets the conditional requirements, featuring an intelligent closed-loop offline functionality; 4. 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. Exclusion Criteria: 1. There are established contraindications associated with the use of nitric oxide, which include the following conditions: 1. Severe hypoplasia of the left heart or duct-dependent congenital heart disease; 2. Life-threatening congenital anomalies and congestive heart failure; 3. Congenital methemoglobinemia; 4. Significant hemorrhagic events, such as intracranial hemorrhage, intraventricular hemorrhage, and pulmonary hemorrhage. 2. 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. 3. 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. 4. 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. 5. Participation in concurrent clinical trials involving other pharmacological agents or medical devices is prohibited. 6. The investigator may determine that participation in this study is not appropriate for certain individuals.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital of Fudan University
RECRUITINGShanghai, China
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