NCT00950287

Detection of Neonatal Bradycardia

Early Detection of Severe Apnea-bradycardia in Preterm Infants Using Algorithm Fusion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (estimated)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 4 Days – 33 Weeks
• Healthy volunteers: Not accepted

Summary

Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment. Duration and amplitude of the bradycardias depend on the time delay between the beginning of the bradycardia and the intervention of the nurse. The purpose of the study is to test a new method set for early detection of bradycardia in preterm infants.

Detailed description

Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment. Duration and amplitude of the bradycardias depend on the time delay between the beginning of the bradycardia and the intervention of the nurse. The purpose of the study is to test in clinical units and in real life a new method set for early detection of bradycardia in preterm infants. Each preterm infant cardio-respiratory traces will be recorded during two 4-hours periods of time (the first one at the time of occurrence of apnea-bradycardias and the second one during the following week). During those periods, the alarms of the monitors usually used in the units will also be recorded through automatic detection and these alarms will be compared with the alarms generated by the algorithm tested, for false positive and precocity of the detection. A false positive alarm is a detection which is not associated with a bradycardia of less than 80 bpm. The system will be considered efficient if it allows an earlier detection of severe bradycardias without increasing the number of false positive detection.

Conditions

• Apnea
• Bradycardia

Interventions

Type	Name	Description
DEVICE	No intervention	The recordings will be performed in neonatal units with the preterm infant remaining in usual condition with limitations of external stimulation during the study period. The usual monitor will remain in function. The intervention of the nurses in case of apnea will not be modified during the study period. The recording will be obtained from derivation of the signal usually recorded by the monitor in use completed in one centre by a polysomnographic recording (Medtronics France SA), in order to test a possible influence of the sleep status on the detection.

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-07-31
• Last updated: 2013-03-08

Locations

3 sites across 1 country: France