Using a vibro-tactile device to treat apnea in premature infants
Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.
This study is testing a new vibrating device to see if it can help premature infants who have breathing pauses feel better and have fewer episodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 34 Weeks to 36 Weeks |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 1 site (Rennes) |
| Trial ID | NCT03651648 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the SENSITACT system, which provides adaptive kinesthetic stimulation to treat apnea-bradycardia events in preterm infants. The device detects apneas in real-time and triggers vibrations on the lower abdomen to stimulate mechanoreceptors, potentially reducing the frequency and severity of these events with minimal arousal. The approach seeks to improve patient comfort and autonomy compared to current treatments, which may not fully address the issue. The study includes premature infants who meet specific criteria and excludes those with certain congenital conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are premature infants born before 34 weeks of gestation who are experiencing significant apnea-bradycardia episodes.
Not a fit: Patients with major congenital neurological abnormalities or severe respiratory tract issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of apnea-bradycardia in premature infants, enhancing their overall comfort and reducing the need for more invasive interventions.
How similar studies have performed: Preliminary studies using similar kinesthetic stimulation devices in adults have shown promising results, indicating potential for success in this novel application for infants.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Rennes
- CHU de Rennes — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Patrick PLADYS, Pr — Rennes University Hospital
- Study coordinator: Patrick PLADYS, Pr
- Email: patrick.pladys@chu-rennes.fr
- Phone: 06 34 19 11 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.