Skip to main content
OpenTrials
Completed

NCT Number: NCT01611740

Contribution of 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

24 week–32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, Maine Et Loire, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: CARESS_PREMI

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2012
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.