Detection of Neonatal Bradycardia (INTEM)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Apnea Bradycardia |
Device: No intervention |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Early Detection of Severe Apnea-bradycardia in Preterm Infants Using Algorithm Fusion |
- Number of false positive alarm detections [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Delay between the beginning of the bradycardia and the detection. Sensitivity, specificity, positive predictive value, negative predictive value [ Time Frame: 1 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | September 2009 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | up to 33 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Preterm infants born before 33 weeks of gestational age with a post conceptional age of less than 36 weeks.
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
Contacts and Locations| France | |
| Nantes University Hospital | |
| Nantes, France | |
| Rennes University Hospital | |
| Rennes, France | |
| Tours University Hospital | |
| Tours, France | |
| Study Director: | Patrick Pladys, MD, PhD | CHU de Rennes |
More Information
No publications provided
| Responsible Party: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00950287 History of Changes |
| Other Study ID Numbers: | 2008-A00898-47, PHRC / 08-05 |
| Study First Received: | July 30, 2009 |
| Last Updated: | March 7, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Rennes University Hospital:
|
apnea-bradycardias preterm infants |
Additional relevant MeSH terms:
|
Apnea Bradycardia Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013