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
|Condition or disease||Intervention/treatment|
|Newborn; Infection Newborn Sepsis||Diagnostic Test: C reactive protein|
|Study Type :||Observational|
|Actual Enrollment :||328 participants|
|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|
- Diagnostic Test: C reactive protein
Addition of C-reactive protein test for management strategies to follow-up febrile neonates in outpatient.
- 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.
- 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.
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
|Sisli Etfal Education and Research Hospital|
|İstanbul, Turkey, 34250|