Effect of Recombinant Human Granulocyte Colony- Stimulating Factor on CD11b in Septic Neonates

Ain Shams University90 enrolled

Overview

The investigators aimed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression.

Neonates are susceptible to septicemia secondary to quantitative and qualitative neutrophilic defects. Granulocyte-colony stimulating factor (G-CSF) stimulates myeloid progenitor cell proliferation and induces selective neutrophil functions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neonatal Sepsis

Interventions

rh-GCSFDRUG

10 ug/kg/day intravenously for 3 days

Eligibility

Sex: ALLMax age: 4 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * newborn infants with postnatal age \< 28 day, * minimum gestational age of 28 weeks and requiring intensive care with clinical signs consistent with the diagnosis of neonatal sepsis, * with or without neutropenia Exclusion Criteria: * neonates with congenital malformation, * major chromosomal abnormalities, * prior use of cytokines or intravenous immunoglobulin, or decreased hemoglobin and/or hematocrit at or below the levels necessitate transfusion

Outcomes

Primary Outcomes

all cause mortality

Time frame: one month

Data from ClinicalTrials.gov

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