Abstract Background This study was conducted to evaluate the clinical effect of Granulocyte Colony Stimulating Factor (GCSF) on prognosis of neonatal sepsis. Materials and Methods Present study is a double- blinded randomized clinical trial, conducted on 46 preterm infants with neutropenia (Absolute Neutrophil Count (ANC) ≤ 5000 / μL) and clinical sepsis. Infants were randomly allocated into two groups. In the first group (treatment group), infants were treated with GCSF for up to 5 consecutive days with 10 μg/ kg in addition to standard treatment protocols, and in other group, infants received normal saline as the placebo. Each infant was monitored for 14 days. Primary outcome was mortality during 14 days after entering the study, and secondary outcome was the incidence of positive blood culture, weight gain on the fourteenth day, the duration of hospitalization and medication side effects. Results In the treated group, only one death was observed (P-value=1.00). However, no positive results for cultures were reported. Only one case in the treatment group and 3 patients in the control group showed feeding intolerance and needed respiratory support (P-value= 0.608). Length of hospitalization was 25 ± 6 days for the treatment group and 30 ± 7 days for the control group which was statistically significant (P-value=0.042). Conclusion The results of this study demonstrated that GCSF could reduce the hospital stay, but no significant effect was observed on mortality rate, respiratory or feeding status.

Keywords: Granulocyte Colony-Stimulating Factor; Infant, Premature; Neutropenia; Sepsis

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