Clinical trial NCT00950287: Detection of Neonatal Bradycardia
Official title: Early Detection of Severe Apnea-bradycardia in Preterm Infants Using Algorithm Fusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apnea
Bradycardia
Keywords: apnea-bradycardias
preterm infants
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2009-07-31
Enrollment: 54
Sex: ALL
Minimum age (years): 4
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants born before 33 weeks of gestational age with a post conceptional age of less than 36 weeks.

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.

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 criteria: 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

Primary outcomes:
measure: Number of false positive alarm detections
timeFrame: 1 week
Secondary outcomes:
measure: Delay between the beginning of the bradycardia and the detection. Sensitivity, specificity, positive predictive value, negative predictive value
timeFrame: 1 week
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Patrick Pladys, MD, PhD
role: STUDY_DIRECTOR
References: