Newborn SepsisIMF-NNNCT03623503
Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis
An observational study of Newborn Sepsis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Newborn Sepsis
- What is being tested?
- Observational study
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2016to 12 Jul 2017
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children born between 1 January and 31 December 2013 and hospitalized in the neonatology department for suspicion of MFIs. Presence of early clinical signs, ie before 72 hours of life.
Who may be able to join
- Children born at the University Hospital Center in Amiens between 1 January and 31 December 2013 and hospitalized in the neonatology department for suspicion of MFIs
Who cannot join
- Child born before 37 weeks of amenorrhea and / or having a failure in the birth room requiring immediate transfer to neonatal resuscitation or intensive care neonatology
Trial locations and contacts
1 site in 1 country.
About this study
Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS. The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.
Read the detailed description
neonatal early onset spesis (EOS) remains animportant etiology of neonatal morbidity and mortality. Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. Diagnosis is difficults due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS.The objective of the study was to identify early clinical signs in newborn infants with suspected neonatal sepsis to differentiate a likely infection with pathogen bacteria in the gastric suction culture.The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.
- Conditions
- Newborn Sepsis
- Being tested
- Observational study
- Keywords
- newborn, neonatal spesis, clinical sriteria
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| first group | Observational study of 25 newborn with a likely EOS Receives: Other: Observational study | |
| second group | Observational study of v33 newborn with a possible EOS Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical signs in newborn infants
The objective of the study was to determine early clinical signs in newborn infants with suspected neonatal sepsis to differentiate a likely infection with pathogen bacteria in gastric suction culture.The investigators conduced a retrospective study and all term newborn infant born between 1 january and 31 december 2013 and hospitalized for suspected EOS were included.From the computerized medical file, which is filled in exhaustively, the data were given in the form of continuous values or in the form of a category: maternal age, gestationality, delivery period, delivery method, childbirth administration of maternal antibiotherapy. the parameters at birth were recorded in the same way: sex of the newborn, measurements of birth (birth weight, height, cranial perimeter).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start21 Feb 2016
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn SepsisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Tourneux, PU-PH, Principal investigator, CHU Amiens-Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623503
- Sponsor's protocol ID
- RNI2016-18- PrTourneux
- Acronym
- IMF-NN
- Status last verified
- Jun 2026
- First submitted
- 2 Aug 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT03623503
- Acronym / sponsor ID
- IMF-NN / RNI2016-18- PrTourneux
- Conditions
- Newborn Sepsis
- Keywords
- newborn, neonatal spesis, clinical sriteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 21 Feb 2016 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 9 Aug 2018 (actual)
- 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.
Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS. The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.
Detailed description
neonatal early onset spesis (EOS) remains animportant etiology of neonatal morbidity and mortality. Neonatal early onset sepsis (EOS) diagnosis is difficult due to lack of sensivity and specificity markers. Diagnosis is difficults due to lack of sensivity and specificity markers. The investigators conduced a restrospectif study to all term born infants born between 1 january and 31 December 2013 and hospitalized for suspect EOS.The objective of the study was to identify early clinical signs in newborn infants with suspected neonatal sepsis to differentiate a likely infection with pathogen bacteria in the gastric suction culture.The presence of neonatal symptoms at birth appears to be a useful clinical marker of probable neonatal EOS.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group | – | Other: Observational studyObservational study of 25 newborn with a likely EOS |
| second group | – | Other: Observational studyObservational study of v33 newborn with a possible EOS |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children born between 1 January and 31 December 2013 and hospitalized in the neonatology department for suspicion of MFIs. Presence of early clinical signs, ie before 72 hours of life.
Key inclusion criteria (1 listed)
- Children born at the University Hospital Center in Amiens between 1 January and 31 December 2013 and hospitalized in the neonatology department for suspicion of MFIs
Key exclusion criteria (1 listed)
- Child born before 37 weeks of amenorrhea and / or having a failure in the birth room requiring immediate transfer to neonatal resuscitation or intensive care neonatology
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 |
|---|---|---|
| Observational study | Other | first group, second group |
Primary outcome
clinical signs in newborn infants
Time frame: 1 year
The objective of the study was to determine early clinical signs in newborn infants with suspected neonatal sepsis to differentiate a likely infection with pathogen bacteria in gastric suction culture.The investigators conduced a retrospective study and all term newborn infant born between 1 january and 31 december 2013 and hospitalized for suspected EOS were included.From the computerized medical file, which is filled in exhaustively, the data were given in the form of continuous values or in the form of a category: maternal age, gestationality, delivery period, delivery method, childbirth administration of maternal antibiotherapy. the parameters at birth were recorded in the same way: sex of the newborn, measurements of birth (birth weight, height, cranial perimeter).
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 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Newborn Sepsis
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NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD)
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Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
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G-CSF In Neonatal Sepsis With Neutropenia
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25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
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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.
Pierre Tourneux, PU-PH principal investigator
CHU Amiens-Picardie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Sepsis, run by Centre Hospitalier Universitaire, Amiens 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 1 inclusion and 1 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 16 Jun 2026. 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?
clinical signs in newborn infants (time frame: 1 year). 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 16 Jun 2026.