Skip to main content
OpenTrials
Completed

NCT Number: NCT00950287

Detection of Neonatal Bradycardia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 day–33 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital, Nantes, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention

Device

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.

Primary outcomes

  1. Number of false positive alarm detections

    Time frame: 1 week

Secondary outcomes

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

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: INTEM

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 31, 2009
Registry last updated
Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.