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Smart machine takes over weaning of lung medicine for sick newborns

NCT ID NCT06832163

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Children's Hospital of Fudan University

    RECRUITING

    Shanghai, China

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