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New Protocol for Febrile Neonate Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03183531
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Ali Bulbul, Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary:
The objective of present study was to evaluate clinical and laboratory characteristics of febrile neonate and describe the incidence of SBI in febrile neonates. Secondarly investigators aimed to test usefulness of major protocols and new protocol in evaluating only febrile neonate.

Condition or disease Intervention/treatment
Newborn; Infection Newborn Sepsis Diagnostic Test: C reactive protein

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Study Type : Observational
Actual Enrollment : 328 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: New Protocol for Identification of Serious Bacterial Infection in Febrile Newborn
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : March 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever


Intervention Details:
  • Diagnostic Test: C reactive protein
    Addition of C-reactive protein test for management strategies to follow-up febrile neonates in outpatient.


Primary Outcome Measures :
  1. Evaluation of characteristics of febrile neonate and describe the incidence of SBI in febrile neonates. [ Time Frame: 5 years ]
    All febrile neonate admitted and evaluated for SBI. An episode of SBI was defined as (A) the growth of a known pathogenic bacteria in one or more of cultures (bacteremia, meningitis, osteomyelitis, suppurative arthritis, urinary tract infection, bacterial enteritis, and pneumonia), (B) any disease commonly associated with bacterial pathogens including pneumonia, acute otitis media, suppurative arthritis, osteomyelitis, and soft-tissue infections (cellulitis, abscess, mastitis, and omphalitis). Pneumonia was defined as a new discrete infiltration on the chest film, which was confirmed by an attending pediatric radiologist with the presence of typical clinical signs and symptoms.

  2. Usefulness of major protocols and new protocol in evaluating only febrile neonate. [ Time Frame: 5 years ]
    All infants were classified at low-risk by the criteria of Rochester, Boston, Philadelphia and new created Sisli Etfal protocols.



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
newborn babies admitted to hospital with fever
Criteria

Inclusion Criteria:

  • All neonates who were admitted to the neonatal intensive care unit with a rectal temperature of ≥38°C (documented at the time of medical evaluation) were eligible for the participation in this study.

Exclusion Criteria:

  • The exclusion criteria were gestational age less than 35 weeks, who refused to participate in the study, chromosome abnormality (e.g., trisomy 21, 18), the presence of a chronic disease, congenital malformations (cyanotic heart disease, meningomyelocele), admission to pediatric surgery, started on antibiotics before admission, and incomplete records.

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): NCT03183531


Locations
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Turkey
Sisli Etfal Education and Research Hospital
İstanbul, Turkey, 34250
Sponsors and Collaborators
Sisli Hamidiye Etfal Training and Research Hospital

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Responsible Party: Ali Bulbul, Associate professor, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03183531    
Other Study ID Numbers: sislietfal.06.2017
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection