Clinical trial NCT01611740: Contribution of Real Time Analyses of CARdio-RESpiratory Signals to the Diagnosis of Infection in PREterM Infants
Official title: Contribution of Computerized Real Time Analyses of Cardio-respiratory Signals to the Diagnosis of Infection in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infection
Keywords: Preterm infant
Bacterial infection
Diagnosis of proven or suspected bacterial infection
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 525
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm birth before \< 32wks and \> 24wks

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Diagnosis of proven or suspected bacterial infection
timeFrame: Within the hospitalisation with an anticipated mean duration of 10 weeks
Secondary outcomes:
measure: 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.
timeFrame: Within the hospitalisation with an anticipated mean duration of 2 to 10 weeks
measure: Periods of discomfort defined as at least two EDIN scores above 3 in a 6 hours period
timeFrame: Within the hospitalisation with an anticipated mean duration of 2 to 10 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
state: Maine Et Loire
city: Lille
country: France
facility: CHU de Lille
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Bruno Laviolle, MD, PhD
role: STUDY_CHAIR
References: