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

NCT01611740 | Completed

• 1 other identifier: 2011-A00324-37
• Study Type: observational
• Target: 525
• Locations: 1 country
• Sites: 3

Brief 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

Bacterial Infection

Keywords

Preterm infant; Bacterial infection; Diagnosis of proven or suspected bacterial infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  Within the hospitalisation with an anticipated mean duration of 2 to 10 weeks

Study Arms (1)

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

Interventions

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.

Preterm infants

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm birth before \< 32wks and \> 24wks

You may qualify if:

• preterm birth before \< 32wks and \> 24wks
• birth weight \> 500g
• postnatal age\> 3 days
• postconceptional age \< 34wks
• parents information and collection of non-opposition

You may not qualify if:

• malformative syndrome
• severe neurological injury (IVH grade 4, cavitary periventricular leukomalacia, perinatal asphyxia post ischemia)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (3)

CHU Angers

Angers, Maine Et Loire, 49933, France

Location

CHU de Lille

Lille, 59035, France

Location

CHU de Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Bacterial Infections; Premature Birth

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Bruno Laviolle, MD, PhD

  Rennes University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: June 5, 2012
• Study Start: May 1, 2012
• Primary Completion: December 24, 2018
• Study Completion: December 24, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

FR (3)