CompletedNot Applicable

Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.

France14 participantsStarted 2019-10-24

Plain-language summary

The goal of the SENSITACT system is to activate an adaptive kinesthetic stimulation to treat apnea-bradycardia events on preterm infants, while minimizing deleterious effects, in particular arousals that can be due either to respiratory efforts or to kinesthetic stimulation itself. This novel system will provide an alternative treatment to apnea-bradycardia, with improved patient comfort and autonomy. In particular, it may become a complementary solution for the current treatments (Manual stimulation by caregivers, continuous or intermittent nasal positive pressure ventilation and methylxanthine therapies) that do not appear to be optimal and usually only allow a partial reduction in the number and severity of apneas.

Who can participate

Age range

34 Weeks – 36 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative duration of apnea-bradycardia

Timeframe: 12 hours (H12)

Trial details

NCT IDNCT03651648

SponsorRennes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-18

View on ClinicalTrials.gov More Apnea of Prematurity trials