NCT03651648View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 18, 2019

Primary Completion Date

January 2, 2024

Study Completion Date

July 2, 2024

Conditions
Apnea of Prematurity
Interventions
DEVICE

SENSITACT System

the activated stimulation (ON period of 6 hours) will be hidden from the care team, who will continue the care according to the usual procedures (blind treatment).

DEVICE

SENSITACT System

the desactivated stimulation (OFF period of 6 hours) will be hidden from the care team, who will continue the care according to the usual procedures (blind treatment).

Trial Locations (1)

35200

RECRUITING

CHU de Rennes, Rennes

All Listed Sponsors
lead

Rennes University Hospital

OTHER