New Protocol for Febrile Neonate Management

NCT03183531 | Completed

• 1 other identifier: sislietfal.06.2017
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn; Infection; Newborn Sepsis

Outcome Measures

Primary Outcomes (2)

• Evaluation of characteristics of febrile neonate and describe the incidence of SBI in febrile neonates.

  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.

  5 years

• Usefulness of major protocols and new protocol in evaluating only febrile neonate.

  All infants were classified at low-risk by the criteria of Rochester, Boston, Philadelphia and new created Sisli Etfal protocols.

  5 years

Interventions

C reactive protein DIAGNOSTIC_TEST

Addition of C-reactive protein test for management strategies to follow-up febrile neonates in outpatient.

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

newborn babies admitted to hospital with fever

You may qualify if:

• 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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Etfal Education and Research Hospital

Istanbul, 34250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infections; Neonatal Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 12, 2017
• Study Start: January 1, 2011
• Primary Completion: December 31, 2015
• Study Completion: March 31, 2016
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

TU (1)