Effect of recombinant granulocyte-colony-stimulating factor on early onset sepsis

Phase 3

• Conditions: Early onset neonatal sepsis.; Other sepsis

• Registration Number: IRCT20190109042311N1
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 February 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Diagnosis of sepsis
Gestational age (GA) below 35 weeks (Range 30-35 weeks)
Birth weight less than 2000 g
Presence of bacteria in the blood culture and infection signs in the first 3 days of life verified early-onset neonatal sepsis
Clinical presentation of infection in the absence of positive blood culture verified clinical sepsis in preterm infants
Sufficient renal and liver functions
Infant age between 1 and 28 days

Exclusion Criteria

APGAR score less than five at five minutes
Major congenital anomaly
Severe birth asphyxia (hypoxic-ischemic encephalopathy)
Maternal severe preeclampsia unresponsive to medical therapy
Systemic hypotension or metabolic disorders
Absolute neutrophil count (ANC) greater than 6,000/µL
Severe lesions like intraventricular hemorrhage with grade III and IV

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
White blood cells count (WBC). Timepoint: At baseline before the study commencement and 3 days after of recombinant granulocyte-colony-stimulating factor administration. Method of measurement: Hemocytometer.