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

Contribution of Computerized Real Time Analyses of Cardio-respiratory Signals to the Diagnosis of Infection in Preterm Infants

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 525

Contacts and Locations

Study Locations

• France
  • Lille, France, 59035
    • CHU de Lille
  • Rennes, France, 35000
    • CHU de Rennes
  • Maine Et Loire
    • Angers, Maine Et Loire, France, 49933
      • Chu Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm birth before < 32wks and > 24wks

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of proven or suspected bacterial infection	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.	Within the hospitalisation with an anticipated mean duration of 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Within the hospitalisation with an anticipated mean duration of 2 to 10 weeks
Periods of discomfort defined as at least two EDIN scores above 3 in a 6 hours period	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.	Within the hospitalisation with an anticipated mean duration of 2 to 10 weeks

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): December 24, 2018
• Study Completion (ACTUAL): December 24, 2018

Study Registration Dates

• First Submitted: May 25, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (ESTIMATE): June 5, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Bacterial infection; Preterm infant; Diagnosis of proven or suspected bacterial infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: 2011-A00324-37