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The role of zinc supplementation in neonatal sepsis

Not Applicable
Conditions
eonatal sepsis.
Other sepsis
Registration Number
IRCT20200810048347N1
Lead Sponsor
Technology and Research Vice-chancellery, Hormozgan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Presence of at least 2 clinical signs of sepsis including pallor or generalized jaundice, cardiovascular manifestations (tachy- or bradycardia, poor perfusion, or shock), change in body temperature (hypo- or hyperthermia), respiratory manifestations (grunting, intercostal retraction, apnea, or cyanosis), neurologic manifestations (hypotonia, lethargy, irritability, or seizure), gastrointestinal symptoms (abdominal distension, hepatosplenomegaly)
CRP >5 mg/ml
Presence of at least 1 positive serum parameter based on Fanarrof (book) including WBC <5000/microliter or >25000 at birth or WBC>30000 12-24 hours after birth or WBC>21000 on the second day of birth or the following days, absolute neutrophil count (ANC) <1800/microliter, platelet count <150000/microliter, immature/total (I/T) neutrophil ratio <0.16 on the first day and <0.13 from the second day on.
Gestational age >37 weeks
Age <28 days
Informed consent of the parents

Exclusion Criteria

Important congenital anomalies such as trisomies
Hypoxic ischemic encephalopathy
Intracranial hemorrhage
Respiratory distress syndrome
Inborn errors of metabolism
Candidiasis

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mortality. Timepoint: At the end of the study. Method of measurement: Based on patient's medical chart.
Secondary Outcome Measures
NameTimeMethod
Time to improvement of clinical symptoms. Timepoint: At the end of the study. Method of measurement: Daily clinical examination.;Hospital length of stay. Timepoint: At the end of the study. Method of measurement: Based on the patient's clinical charts.
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