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

NCT03623503 | Completed

• 1 other identifier: RNI2016-18- PrTourneux
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Newborn Sepsis

Keywords

newborn; neonatal spesis; clinical sriteria

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Study Arms (2)

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

Interventions

Observational study OTHER

first group; second group

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Observation

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Pierre Tourneux, MD, PhD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 9, 2018
• Study Start: February 21, 2016
• Primary Completion: July 12, 2017
• Study Completion: July 12, 2017
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share