Detection of Neonatal Bradycardia

Completed

• Conditions: Apnea; Bradycardia
• Interventions: Device: No intervention

• Registration Number: NCT00950287
• Lead Sponsor: Rennes University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Study Start: 2009-09
• Status Verified: 2012-06
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Parents informed consent
• Presenting with at least 2 significant apnea bradycardia (apnea + decrease in heart rate of more than 33% during at least 4 sec)

Exclusion Criteria

• Postnatal age of less than 4 days
• Mechanical ventilation
• Severe neurological lesion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cohort	No intervention	One group of preterm infants

Primary Outcome Measures

Name	Time	Method
Number of false positive alarm detections	1 week

Secondary Outcome Measures

Name	Time	Method
Delay between the beginning of the bradycardia and the detection. Sensitivity, specificity, positive predictive value, negative predictive value	1 week

Trial Locations

Locations (3)

Nantes University Hospital; 🇫🇷 Nantes, France

Tours University Hospital; 🇫🇷 Tours, France

Rennes University Hospital; 🇫🇷 Rennes, France