Detection of Neonatal Bradycardia
INTEM
Early Detection of Severe Apnea-bradycardia in Preterm Infants Using Algorithm Fusion
2 other identifiers
observational
54
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2009
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 31, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 8, 2013
June 1, 2012
3.5 years
July 30, 2009
March 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of false positive alarm detections
1 week
Secondary Outcomes (1)
Delay between the beginning of the bradycardia and the detection. Sensitivity, specificity, positive predictive value, negative predictive value
1 week
Study Arms (1)
cohort
One group of preterm infants
Interventions
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.
Eligibility Criteria
Preterm infants born before 33 weeks of gestational age with a post conceptional age of less than 36 weeks.
You may qualify if:
- 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)
You may not qualify if:
- Postnatal age of less than 4 days
- Mechanical ventilation
- Severe neurological lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rennes University Hospitallead
- Ministry of Health, Francecollaborator
Study Sites (3)
Nantes University Hospital
Nantes, France
Rennes University Hospital
Rennes, France
Tours University Hospital
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Patrick Pladys, MD, PhD
Rennes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2009
First Posted
July 31, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
March 8, 2013
Record last verified: 2012-06