Detection of Neonatal Bradycardia (INTEM)

March 7, 2013 updated by: Rennes University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Nantes university hospital
      • Rennes, France
        • Rennes University Hospital
      • Tours, France
        • Tours university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 days to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants born before 33 weeks of gestational age with a post conceptional age of less than 36 weeks.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cohort
One group of preterm infants
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of false positive alarm detections
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Delay between the beginning of the bradycardia and the detection. Sensitivity, specificity, positive predictive value, negative predictive value
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Ministry of Health, France

Investigators

  • Study Director: Patrick Pladys, MD, PhD, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 30, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

July 31, 2009

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-A00898-47
  • PHRC / 08-05 (Other Identifier: Rennes University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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