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New breathing device for newborns tested against standard care

NCT ID NCT02030691

Symptom relief Sponsor: University Hospital, Bordeaux 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested two non-invasive breathing machines in 49 newborns (born at 33 weeks or later) with respiratory distress. One machine is the standard nasal CPAP, and the other is a newer device called nasal high frequency percussive ventilation. Researchers measured brain oxygen levels to see which device babies tolerated better. The goal was to see if the newer device could be a good alternative.

What this could mean

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

Active substance
Nasal continuous positive airway pressure (nCPAP) and nasal high frequency percussive ventilation (nHFPV) devices
What this could lead to
If successful, this could show that a newer breathing device is as well-tolerated as the standard one, potentially offering another option for supporting newborns with breathing problems.
What could go wrong
This is a small, completed study with only 49 babies, so results may not apply to all newborns. It compares tolerance, not long-term outcomes, so it won't tell us which device is better for overall health.

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

49 people

The number who actually took part.

Start date

May 2014

Finished

Nov 2016

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

Up to 30 minutes

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: * Inborn neonate. * Delivered by vaginal delivery or caesarean section. * Gestational age greater than or equal to 33 weeks of gestation. * Birth weight \> 1kg. * Respiratory distress with a Silverman score greater than or equal to 4 after 10 minutes of life. * Signed parental informed consent. Exclusion Criteria: * Meconium aspiration syndrome. * Congenital anomalies such as heart anomalies, congenital cystic adenomatoid malformation, diaphragmatic hernia…

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome Pulmonary Atelectasis

As listed by the trial registrant

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

Neonatal respiratory distress

Contacts and locations

Locations

  • Service de Néonatalogie - Maternité - Hôpital Pellegrin

    Bordeaux, Bordeaux, 33076, France

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