Clinical trial NCT03651648: Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.
Official title: Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apnea of Prematurity
Keywords: apnea; prematurity; kinesthetic stimulation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 24
Sex: ALL
Minimum age (years): 34
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: The main hypothesis behind the SENSITACT system is that kinesthetic stimulation can terminate apneas-bradycardias with minimal patient arousal. The aim is to stimulate mechanoreceptors through the skin by kinesthetic stimulation on the lower abdominal zone. This is a region of the body that is covered with Pacinian corpuscles, a very sensitive kind of mechanoreceptors, which respond to rapid vibrations on the skin (200-300 Hz). Vibro-tactile stimulation of these mechano-receptors will trigger a reaction typical of the startle reflex. This reflex causes 1) an immediate myotonic reaction and 2) a widespread autonomic response. The former should have a direct effect on obstructive respiratory disorders with an increase in chin muscle tones within 80 to 100 ms. The latter should act on central respiratory disorders, with activation of the sympathetic nervous system. Since both responses are mediated via sub-cortical nervous center, it is expected that patient arousal will be limited. Preliminary clinical studies on adult patients conducted by LTSI, Sorin CRM and CHU de Grenoble (Skin\&SAS, HYPNOS, EKINOx), that have used the same PASITHEA stimulation device have confirmed activation of the sympathetic nervous system and a significant reduction in the duration of apnea or hypopnea events, while no differences were observed on patients' sleep architecture.

The SENSITACT system is able to detect apneas-bradycardias in real-time, so that kinesthetic stimulation can be triggered to stop respiratory disorders very early during the event. Detection is performed within the SENSITACT controller station that receives data from all sensors connected to the Patient Monitor in real-time. 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.

Kinesthetic stimulation is stopped when a normal condition (normal cardiac rhythm) is detected or when a maximum number of stimulation pulses have been reached.

Eligibility 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).

Primary outcomes:
measure: Cumulative duration of apnea-bradycardia
timeFrame: 12 hours (H12)
Secondary outcomes:
measure: Distribution of bradycardia durations
timeFrame: 12 hours (H12)
measure: Depth of bradycardia
timeFrame: 12 hours (H12)
measure: Depth of desaturations
timeFrame: 12 hours (H12)
measure: Caregiver interventions
timeFrame: 12 hours (H12)
measure: Cardiorespiratory parameters in response to stimulation
timeFrame: 6 hours (H6)
measure: Premature's sleep-wake cycles
timeFrame: 12 hours (H12)
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Patrick PLADYS, Pr
role: PRINCIPAL_INVESTIGATOR
References: