Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Vibrating device offers new hope for premature babies with breathing pauses

NCT ID NCT03651648

Symptom relief Sponsor: Rennes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new device that uses gentle vibrations to treat breathing pauses (apnea) in premature babies. The device automatically detects when a baby stops breathing and delivers a mild vibration to stimulate breathing. The goal was to reduce the need for manual stimulation by caregivers and improve comfort. The study included 14 premature infants who were already receiving standard care.

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

14 people

The number who actually took part.

Started

Oct 2019

Finished

Jan 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

34 to 36 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: * written informed consent, * Premature infants, * born to a term less than 34 weeks of amenorrhea (AS), * Age less than 36 weeks post-menstrual age, * With a postnatal age greater than 4 days, * caffeine treated, for at least 36 hours, * Presenting episodes of bradycardia apnea significant (\>10 sec with bradycardia \<100 bpm or SaO2\<80%) with an interval of less than 6 hours between two episodes observed in the 24 hours preceding inclusion. Exclusion Criteria: * Major congenital neurological abnormalities, * Congenital abnormalities of the respiratory tracts, * HIV grade 3 or 4, * Periventricular leukomalacia, * Invasive ventilation and non-invasive ventilation in NAVA mode, * Cyanogenic malformative heart disease, * Sepsis diagnosed in the 4 days prior to registration (CRP\> 10mg / L), * maternal addiction during pregnancy, * Father and / or mother legally protected (under judicial protection, guardianship or supervision).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Apnea of prematurity are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Apnea apnea of prematurity Premature Birth

As listed by the trial registrant

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

Apnea of prematurity

Contacts and locations

Locations

  • CHU de Rennes

    Rennes, 35200, France

More trials for these conditions

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