Contribution of Real Time Analyses of CARdio-RESpiratory Signals to the Diagnosis of Infection in PREterM Infants (CARESS_PREMI)

This study is currently recruiting participants.
Verified December 2013 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01611740
First received: May 25, 2012
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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 Intervention
Bacterial Infection
Procedure: Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contribution of Computerized Real Time Analyses of Cardio-respiratory Signals to the Diagnosis of Infection in Preterm Infants

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Diagnosis of proven or suspected bacterial infection [ Time Frame: Within the hospitalisation with an anticipated mean duration of 10 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: May 2012
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Preterm infants
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 :

  • the variability of the cardiac cycle duration ;
  • the variability of respiratory cycle amplitude and duration ;
  • and their relationships.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Preterm birth before < 32wks and > 24wks

Criteria

Inclusion Criteria:

  • preterm birth before < 32wks and > 24wks
  • birth weight > 500g
  • postnatal age> 3 days
  • postconceptional age < 34wks
  • parents information and collection of non-opposition

Exclusion Criteria:

  • malformative syndrome
  • severe neurological injury (IVH grade 4, cavitary periventricular leukomalacia, perinatal asphyxia post ischemia)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611740

Contacts
Contact: Alain Beuchée, MD 2 99 28 25 17 ext + 33 alain.beuchee@chu-rennes.fr

Locations
France
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         
CHU de Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: Hugues PATURAL, MD         
Principal Investigator: Hugues Patural, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Study Chair: Bruno Laviolle, MD, PhD CHU de Rennes
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01611740     History of Changes
Other Study ID Numbers: 2011-A00324-37
Study First Received: May 25, 2012
Last Updated: December 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Preterm infant
Bacterial infection
Diagnosis of proven or suspected bacterial infection

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on April 16, 2014