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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 months
Maximum Age: 8 months
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU de Rennes
RECRUITING
Rennes
Contact Information
Primary
Patrick PLADYS, Pr
patrick.pladys@chu-rennes.fr
06 34 19 11 30
Time Frame
Start Date: 2019-10-18
Estimated Completion Date: 2024-07-02
Participants
Target number of participants: 24
Treatments
Experimental: SENSITACT System ON
As soon as the early signs of an apnea-bradycardia are detected, the SENSITACT controller sends a trigger signal to the PASITHEA stimulator that immediately activates kinesthetic stimulation
Sham_comparator: SENSITACT System OFF
The SENSITACT controller doesnt send any trigger signal to the PASITHEA stimulator even if an early sign of an apnea-bradycardia is detected.
Sponsors
Leads: Rennes University Hospital

This content was sourced from clinicaltrials.gov