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Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis (IMF-NN)

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ClinicalTrials.gov Identifier: NCT03623503
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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.

Condition or disease Intervention/treatment
Newborn Sepsis Other: Observational study

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
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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Criteria for a Pathogen in Term Newborn Suspected of Neonatal Sepsis
Actual Study Start Date : February 21, 2016
Actual Primary Completion Date : July 12, 2017
Actual Study Completion Date : July 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Groups and Cohorts
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Group/Cohort Intervention/treatment
first group
Observational study of 25 newborn with a likely EOS
 Other: Observational study
second group
Observational study of v33 newborn with a possible EOS
 Other: Observational study


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623503


Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Pierre Tourneux, MD, PhD CHU AMIENS
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03623503    
Other Study ID Numbers: RNI2016-18- PrTourneux
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
newborn
neonatal spesis
clinical sriteria
Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases