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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC / 08-05 | Other Identifier | Rennes University Hospital |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort | One group of preterm infants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of false positive alarm detections | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Delay between the beginning of the bradycardia and the detection. Sensitivity, specificity, positive predictive value, negative predictive value | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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Preterm infants born before 33 weeks of gestational age with a post conceptional age of less than 36 weeks.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Pladys, MD, PhD | Rennes University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | France | ||||
| Rennes University Hospital |
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| ID | Term |
|---|---|
| D001049 | Apnea |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Rennes |
| France |
| Tours University Hospital | Tours | France |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |