Contribution of Real Time Analyses of CARdio-RESpiratory Signals to the Diagnosis of Infection in PREterM Infants
Condition: Bacterial Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Observational

Summary: 
      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.
    

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.
    

Intervention name(s): Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642
Intervention type(s): Procedure
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm birth before < 32wks and > 24wks
      
Keywords: Preterm infant; Bacterial infection; Diagnosis of proven or suspected bacterial infection