Tiny lungs, big comparison: which breathing aid works best for preemies?
NCT ID NCT03700606
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.
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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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80 people
The number who actually took part.
- Started
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Mar 2019
- Finished
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Feb 2022
- 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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23 to 28 weeks
- 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: * 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
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Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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