NCT00950287|Completed
Detection of Neonatal Bradycardia
INTEM
Early Detection of Severe Apnea-bradycardia in Preterm Infants Using Algorithm Fusion
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INTEM
Early Detection of Severe Apnea-bradycardia in Preterm Infants Using Algorithm Fusion
Sponsor study identifier
Secondary identifiers
OTHER · Rennes University Hospital
observational
54
1 country
3
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Actual (reported)Study Completion
March 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 30, 2009
Actual (reported)July 31, 2009
Actual (reported)September 2009
Date type not reportedThis date has not been verified as actual or estimated.
March 2013
Actual (reported)March 2013
Actual (reported)Number of false positive alarm detections
1 week
Delay between the beginning of the bradycardia and the detection. Sensitivity, specificity, positive predictive value, negative predictive value
1 week
One group of preterm infants
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Preterm infants born before 33 weeks of gestational age with a post conceptional age of less than 36 weeks.
Nantes University Hospital
Nantes, France
Rennes University Hospital
Rennes, France
Tours University Hospital
Tours, France
Patrick Pladys, MD, PhD
Rennes University Hospital
First Submitted
July 30, 2009
First Posted
July 31, 2009
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
March 2013
Actual (reported)Last Updated
March 8, 2013
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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