Detection of Neonatal Bradycardia (INTEM)

Rennes University Hospital

Status: Completed

Conditions: Bradycardia; Apnea

Treatments: Device: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT00950287

2008-A00898-47

PHRC / 08-05 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 4 days to 33 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

54 participants in 1 patient group

cohort

Description:

One group of preterm infants

Treatment:

Device: No intervention