NCT01611740

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 525 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 24 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2018-12-24
• Completion: 2018-12-24
• First posted: 2012-06-05
• Last updated: 2019-01-24

Locations

3 sites across 1 country: France