Contribution of Real Time Analyses of CARdio-RESpiratory Signals to the Diagnosis of Infection in PREterM Infants (CARESS_PREMI)
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|ClinicalTrials.gov Identifier: NCT01611740|
Recruitment Status : Recruiting
First Posted : June 5, 2012
Last Update Posted : August 29, 2017
Hospital-acquired infections are common complications in preterm infants. The diagnosis has to be fast and accurate. Indeed, the early identification of a suspected infection is very important, since the early administration of antibiotics lowers the risk of septic shock and improves long term outcome in the infected newborns who survive. Besides, a high specificity in the diagnosis of infection allows for the reduction of inappropriate treatment and thus prevents the emergence of antibiotic resistance.
The aim of this study is to develop a computer-assisted diagnosis tool, based on the real time analysis of cardio-respiratory signals, to aid the neonatologist in the diagnosis of infection of the preterm infant, at the bedside.
|Condition or disease||Intervention/treatment|
|Bacterial Infection||Procedure: Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642|
Hospital-acquired infections increase morbidity and mortality in the preterm infants. Early diagnosis of infection is difficult mainly due to the poor performance of clinical signs and to the need for invasive procedure to get blood tests. However, early administration of antibiotics lowers the risk of septic shock and improves long term outcome in the infected newborns who survive. Many clinical features have been described, associated with an ongoing infection but they are inconsistent, variable and nonspecific. Similarly, many invasive laboratory tests have been proposed for the diagnosis of infection in the newborn but they all need blood sampling and none has a good predictive value.
The combined analysis of the heart rate and respiratory characteristics appears to be a promising tool for the diagnosis of infection in the preterm infants. These signals are non-invasively recorded and their computerized real time analyses would allow for a continuous assessment of the risk of infection.
The main objective is to test the hypothesis that the analyses of the variability of the cardiac cycle duration, the variability of the respiratory cycle amplitude and duration, and their relationships, can significantly improve the performance of the diagnosis of late onset infection in the preterm infant at the bedside in neonatal units.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Contribution of Computerized Real Time Analyses of Cardio-respiratory Signals to the Diagnosis of Infection in Preterm Infants|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||January 2018|
Telemonitoring system prototype developed by INSERM U-642
Procedure: Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642
Telemonitoring system prototype developed by INSERM U-642 with analysis of :
- Diagnosis of proven or suspected bacterial infection [ Time Frame: Within the hospitalisation with an anticipated mean duration of 10 weeks ]The primary outcome will be the efficiency (area under curve, sensitivity, specificity, false-positive and false-negative) of the combined analysis of heart rate and respiratory characteristics for the diagnosis of proven or suspected bacterial infection.
- Inflammation without proven or suspected bacterial infection defined as follows: a 6 hours period with CRP> 5 mg/L not classified as proven or suspected bacterial infection. [ Time Frame: Within the hospitalisation with an anticipated mean duration of 2 to 10 weeks ]We will investigate if this approach can discriminate an inflammation without proven or suspected bacterial infection defined as follows: a 6 hours period with CRP> 5 mg/L not classified as proven or suspected bacterial infection.
- Periods of discomfort defined as at least two EDIN scores above 3 in a 6 hours period [ Time Frame: Within the hospitalisation with an anticipated mean duration of 2 to 10 weeks ]The performance of a biomarker based on the computerized analyses of the cardiac and respiratory signals will also be tested for the detection of periods of discomfort defined as at least two EDIN scores above 3 in a 6 hours period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611740
|Contact: Alain Beuchée, MD||2 99 28 25 17 ext + email@example.com|
|Angers, Maine et Loire, France, 49933|
|Principal Investigator: Géraldine GASCOIN-LACHAMBRE, MD|
|CHU de Lille||Recruiting|
|Lille, France, 59035|
|Contact: Laurent STORME, MD, PhD|
|Principal Investigator: Laurent STORME, MD, PhD|
|CHU de Rennes||Recruiting|
|Rennes, France, 35000|
|Principal Investigator: Alain BEUCHEE, MD|
|Sub-Investigator: Patrick Pladys, MD, PhD|
|Study Chair:||Bruno Laviolle, MD, PhD||Rennes University Hospital|