Bacterial InfectionCARESS_PREMINCT01611740
Contribution of Real Time Analyses of CARdio-RESpiratory Signals to the Diagnosis of Infection in PREterM Infants
An observational study of Bacterial Infection, run by Rennes University Hospital at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Bacterial Infection
- What is being tested?
- Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642
- Type of treatment
- Surgery or procedure
- How many people
- 525 participants
- Where
- 3 sitesFrance
- Study dates
- May 2012to 24 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm birth before < 32wks and > 24wks
Who may be able to join
- preterm birth before < 32wks and > 24wks
- birth weight > 500g
- postnatal age> 3 days
- postconceptional age < 34wks
- parents information and collection of non-opposition
Who cannot join
- malformative syndrome
- severe neurological injury (IVH grade 4, cavitary periventricular leukomalacia, perinatal asphyxia post ischemia)
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Angers
Angers, Maine Et Loire, 49933
CHU de Lille
Lille, 59035
CHU de Rennes
Rennes, 35000
About this study
Official title: Contribution of Computerized 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.
Read the 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
- Being tested
- Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642
- Keywords
- Preterm infant, Bacterial infection, Diagnosis of proven or suspected bacterial infection
- Medical subject headings
- Bacterial Infections, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | Telemonitoring system prototype developed by INSERM U-642 Receives: Procedure: Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: Within the hospitalisation with an anticipated mean duration of 2 to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMay 2012
- Primary completion24 Dec 2018
- Study completion24 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Laviolle, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611740
- Sponsor's protocol ID
- 2011-A00324-37
- Acronym
- CARESS_PREMI
- Status last verified
- Jan 2019
- First submitted
- 25 May 2012
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Computerized Real Time Analyses of Cardio-respiratory Signals to the Diagnosis of Infection in Preterm Infants
- ClinicalTrials.gov ID
- NCT01611740
- Acronym / sponsor ID
- CARESS_PREMI / 2011-A00324-37
- Conditions
- Bacterial Infection
- Keywords
- Preterm infant, Bacterial infection, Diagnosis of proven or suspected bacterial infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 24 Dec 2018 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | – | Procedure: Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642Telemonitoring system prototype developed by INSERM U-642 |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm birth before < 32wks and > 24wks
Key inclusion criteria (5 listed)
- preterm birth before < 32wks and > 24wks
- birth weight > 500g
- postnatal age> 3 days
- postconceptional age < 34wks
- parents information and collection of non-opposition
Key exclusion criteria (2 listed)
- malformative syndrome
- severe neurological injury (IVH grade 4, cavitary periventricular leukomalacia, perinatal asphyxia post ischemia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642Telemonitoring 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. | Procedure or surgery | Preterm infants |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Laviolle, MD, PhD study chair
Rennes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infection, run by Rennes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of proven or suspected bacterial infection (time frame: Within the hospitalisation with an anticipated mean duration of 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.