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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00950287
Other study ID # 2008-A00898-47
Secondary ID PHRC / 08-05
Status Completed
Phase N/A
First received July 30, 2009
Last updated March 7, 2013
Start date September 2009
Est. completion date March 2013

Study information

Verified date June 2012
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 33 Weeks
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Nantes University Hospital Nantes
France Rennes University Hospital Rennes
France Tours University Hospital Tours

Sponsors (2)

Lead Sponsor Collaborator
Rennes University Hospital Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of false positive alarm detections 1 week No
Secondary Delay between the beginning of the bradycardia and the detection. Sensitivity, specificity, positive predictive value, negative predictive value 1 week No
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