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New nasal device could ease breathing for preemies

NCT ID NCT03171129

Symptom relief Sponsor: Loma Linda University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new device called ADINA to standard high-flow nasal cannula for giving oxygen to premature babies with breathing distress. About 40 babies in the NICU will take part. The goal is to see if ADINA works as well as the usual method and to check for safety issues like lung collapse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA) device
What this could lead to
If it works, this could offer a simpler, pressure-limited oxygen delivery option for premature babies with breathing problems.
What could go wrong
This is a small, early feasibility study with only 40 babies, so results may not apply broadly. There is a risk of pneumothorax (collapsed lung) as with any oxygen therapy.

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 40 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

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

23 to 40 weeks

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: * Neonates admitted to NICU * Weights of 400-500 grams * Requiring oxygen greater than 30% * No evidence of focal lobar consolidation in lung fields Exclusion Criteria: * Intolerance to procedure * gelatinous skin * known allergy to adhesive material * interference with therapy * profound sepsis * pneumonia * unmanaged apnea/bradycardia * known or suspect complex congenital heart disease * severe cleft lip or palate * suspect or proven lethal congenital anomaly * intolerance to the interface used in the devices * inability to secure an appropriate fit of the patient nasal interface * considered non-viable or of uncertain viability * parental refusal.

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Conditions

The condition(s) this trial relates to.

Dyspnea Hyaline Membrane Disease neonatal respiratory failure newborn respiratory distress syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory distress neonatal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    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

  • Loma Linda University Medical Center

    Loma Linda, California, 92354, United States

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