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Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis

Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03623503
Acronym
IMF-NN
Enrollment
58
Registered
2018-08-09
Start date
2016-02-21
Completion date
2017-07-12
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Sepsis

Keywords

newborn, neonatal spesis, clinical sriteria

Brief 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. 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.

Interventions

OTHERObservational study

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
clinical signs in newborn infants1 yearThe 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).

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPierre Tourneux, PU-PH

CHU Amiens-Picardie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026