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Detection of Neonatal Bradycardia (INTEM)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00950287
First received: July 30, 2009
Last updated: March 7, 2013
Last verified: June 2012
  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

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Number of false positive alarm detections [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

Preterm infants born before 33 weeks of gestational age with a post conceptional age of less than 36 weeks.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950287

Locations
France
Nantes University Hospital
Nantes, France
Rennes University Hospital
Rennes, France
Tours University Hospital
Tours, France
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Study Director: Patrick Pladys, MD, PhD Rennes University Hospital
  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
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on November 25, 2014