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Tiny lungs, big comparison: which breathing aid works best for preemies?

NCT ID NCT03700606

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how two different breathing devices affect the lungs of extremely low birth weight babies. Researchers compared a high-flow nasal cannula to nasal CPAP in 80 stable premature infants. They measured lung function using a special imaging technique to see which method helped babies breathe better.

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

80 people

The number who actually took part.

Started

Mar 2019

Finished

Feb 2022

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 28 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: * 23 to 28+6 weeks gestational age at birth * Corrected gestational age less than or equal to 30 weeks * Over 72 hours of life * Stable on Nasal CPAP of 5-7cm H20 * Hemodynamically stable * Tolerating routine handling * Nares size appropriate for Fisher \& Paykel Optiflow Jr 2 HFNC size XS or small * Successfully extubated for 12 hours after administration of surfactant * Caffeine Citrate at a maintenance dose of 5 to 10 mg /kg * Transcutaneous monitoring in place * Stable blood gas (pH\>/= 7.25 and PaCO2 \<60 mmHg torr) Exclusion Criteria: * Prior pneumothorax or evidence of pulmonary interstitial emphysema. * Prior or current pulmonary hemorrhage * Congenital airway malformations * Major cardiopulmonary malformations * Congenital Diaphragmatic hernia or untreated bowel obstruction * Poor respiratory drive unresponsive to CPAP therapy * Requirement of a nCPAP of \>8 cmH20 or FiO2 \> 0.3 to maintain oxygen saturations between 90-95 percent. * Receiving positive pressure breaths or SIPAP on prongs * Conflicting clinical trial * Clinically unstable per physician discretion

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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.

Contacts and locations

Locations

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123, United States

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Other studies related to the condition(s) this trial covers.