Bradycardia Clinical Trial
Official title:
Early Detection of Severe Apnea-bradycardia in Preterm Infants Using Algorithm Fusion
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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