New Protocol for Febrile Neonate Management

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03183531
• Date of registration: 06/06/2017
• Prospective Registration: No
• Primary sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Public title: New Protocol for Febrile Neonate Management
• Scientific title: New Protocol for Identification of Serious Bacterial Infection in Febrile Newborn
• Date of first enrolment: January 1, 2011
• Target sample size: 328
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03183531
• Study type: Observational
• Phase: N/A

Countries of recruitment

Turkey

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 28 Days
Gender: All

Health Condition(s) or Problem(s) studied

Newborn Sepsis

Newborn; Infection

Intervention(s)

Diagnostic Test: C reactive protein

Primary Outcome(s)

Usefulness of major protocols and new protocol in evaluating only febrile neonate. [Time Frame: 5 years]

Evaluation of characteristics of febrile neonate and describe the incidence of SBI in febrile neonates. [Time Frame: 5 years]

Secondary ID(s)

sislietfal.06.2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors