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

NCT01611740 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 525

Last updated 2019-01-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Bruno Laviolle, MD, PhD · Rennes University Hospital

Eligibility

Min Age
24 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2018-12-24
Completion
2018-12-24

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01611740 on ClinicalTrials.gov