Neonatal Bacterial InfectionPCT_CORDONNCT02858700
Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection
A study testing dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP in people with Neonatal Bacterial Infection, run by University Hospital, Montpellier at 1 site in France.
Trial summary
After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP), the pediatrician must make a difficult decision quickly or not to prescribe additional examinations and / or hospitalize or not the newborn in order to administer parenteral antibiotics. Read more about this study
- Who is it for?
- Ages 1 minute to 30 minutesHealthy volunteers can take part
- Conditions the study is for
- Neonatal Bacterial Infection
- What is being tested?
- dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Dec 2015
- Phase
- Interventional
- 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 1 minute to 30 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth to motherhood.
- Term > 34 weeks .
- Presence of at least one of the factors of major or minor infection risk
Who cannot join
- cord blood sample unavailable.
- Death in the delivery room
- Corticosteroids prenatally (modification of cytokine production ) .
Trial locations and contacts
1 site in 1 country.
About this study
After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP), the pediatrician must make a difficult decision quickly or not to prescribe additional examinations and / or hospitalize or not the newborn in order to administer parenteral antibiotics. This decision takes into account several contextual data, (clinical, biological and bacteriological clinical data) to be considered simultaneously. These information lack sensitivity and specificity.
Therefore, the common attitude among newborns in many countries remains the achievement of a significant number of additional tests and the establishment, without a prior evidence of infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization. However, the diagnosis of IBNP posteriori, is often reversed. This attitude is:
- one source to higher health care costs (hospitalization, additional examinations)
- Selection of the bacterial ecology of the newborn and neonatal services and
- stress for the newborn and parents
- Conditions
- Neonatal Bacterial Infection
- Being tested
- dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP
- Keywords
- neonatal bacterial infection, procalcitonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNPBiological
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord blood procalcitonin | Experimental | dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP Receives: Biological: dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
value of the procalcitonin in the umbilical cord blood
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startApr 2009
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858700
- Sponsor's protocol ID
- 8271
- Acronym
- PCT_CORDON
- Status last verified
- Aug 2016
- First submitted
- 21 Jul 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection
- ClinicalTrials.gov ID
- NCT02858700
- Acronym / sponsor ID
- PCT_CORDON / 8271
- Conditions
- Neonatal Bacterial Infection
- Keywords
- neonatal bacterial infection, procalcitonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Aug 2016 (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.
After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP), the pediatrician must make a difficult decision quickly or not to prescribe additional examinations and / or hospitalize or not the newborn in order to administer parenteral antibiotics. This decision takes into account several contextual data, (clinical, biological and bacteriological clinical data) to be considered simultaneously. These information lack sensitivity and specificity.
Therefore, the common attitude among newborns in many countries remains the achievement of a significant number of additional tests and the establishment, without a prior evidence of infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization. However, the diagnosis of IBNP posteriori, is often reversed. This attitude is:
- one source to higher health care costs (hospitalization, additional examinations)
- Selection of the bacterial ecology of the newborn and neonatal services and
- stress for the newborn and parents
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| umbilical cord blood procalcitonin | Experimental | Biological: dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNPdosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP |
Who may qualify
- Ages
- 1 minute to 30 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birth to motherhood.
- Term > 34 weeks .
- Presence of at least one of the factors of major or minor infection risk
Key exclusion criteria (3 listed)
- cord blood sample unavailable.
- Death in the delivery room
- Corticosteroids prenatally (modification of cytokine production ) .
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 |
|---|---|---|
| dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP | Biological | umbilical cord blood procalcitonin |
Primary outcome
value of the procalcitonin in the umbilical cord blood
Time frame: up to 1 hour
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 8 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP in people with Neonatal Bacterial Infection, run by University Hospital, Montpellier at 1 site 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 3 inclusion and 3 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 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
value of the procalcitonin in the umbilical cord blood (time frame: up to 1 hour). 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 8 Aug 2016.