G-CSF in treatment of premature neonates with neutropenia and clinical sepsis

Not Applicable

Conditions: neonatal sepsis.
Other infectious diseases

Registration Number: IRCT201303252639N11

Lead Sponsor: Deputy for research of Shahid Sadoughi University of Medical Sciences , Yazd, Iran .

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 40

Inclusion Criteria

1- Gestational age of 30-37 weeks
2- Age of less than 10 days
3- Total neutrophil count = 5000 in µL
4- The neonate has sepsis based on clinical criteria
Exclusion criteria:
1- Severe asphyxia
2- Life threatening congenital malformations
3- Total leukocytes count = 20.000 in µL
4- Intraventricular hemorrhage grade 3 or 4
5- Thrombocytopenia ( platelets less than 150000 in µL)
6- Anemia ( Hemoglobin=10g/dL)
7- Metabolic acidosis (PH = 7.2)

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxygen dependency. Timepoint: continuously. Method of measurement: pulse oximetery.;Need to mechanical ventilation. Timepoint: continuously. Method of measurement: pulse oximetery.;Amount of tolerated feeding. Timepoint: daily. Method of measurement: clinical exam.;Mortality. Timepoint: continuously. Method of measurement: clinical exam.;Side effects of injection. Timepoint: continuously. Method of measurement: clinical exam.

Secondary Outcome Measures

Name	Time	Method
Confirmed documented sepsis by cultures. Timepoint: at the end of fourteenth day of the study. Method of measurement: based on results of cultures.;Occurrence of abdominal distension. Timepoint: continuously. Method of measurement: clinical examination.;Fever occurrence and its duration. Timepoint: continuously. Method of measurement: clinical examination.;Thrombocytopenia. Timepoint: daily. Method of measurement: laboratory.