Effect of Enteral Administration of Granulocyte-Colony Stimulating Factor (G-CSF) on Feeding Tolerance in Very Low Birth Weight and Extremely Low Birth Weight Neonates; a Historical-Controlled Clinical Trial

Background: The current study aimed to investigate the effect of enteral Granulocyte-Colony Stimulating G-CSF (Factor) on feeding tolerance in very low birth weight (VLBW) and extremely low birth weight (ELBW) neonates. Methods: This historical-controlled clinical trial was conducted on VLBW and ELBW neonates admitted to Mahdieh Hospital, affiliated to Shahid Beheshti University of Medical Sciences, Tehran, Iran, between July 2016 and March 2017. In the intervention group, 81 neonates with birth weights of 710-1480 were given enteral 5 μg/kg/day of G-CSF (which has been approved by the US FDA) for 7 consecutive days. On the other hand, the control group included 191 neonates who did not receive G-CSF with birth weights of 600-1490 admitted during 24 months prior to the study. The two groups were compared in terms of adverse effects of treatment, primary and secondary outcomes. Results: The mean of gestational age and birth weight in the G-CSF group were reported as 29.96±2.47 weeks and 1204.81±201.68 grams, and these values in the control group were measured at 29.77±2.13 weeks and 1189.47±207.89 grams, respectively. Neonates who received G-CSF demonstrated better feeding tolerance, as reflected by the earlier achievement of 50, 75, 100, full enteral feeding of 150, and maximal enteral feeding of 180 mL/kg/day (p 0.05), with earlier weight gain and a shorter hospital stay. The rate of necrotizing enteroc olitis (NEC) in the G-CSF group was measured at 3.7% that was significantly lower, as compared to the control group (P=0.005). Approximately 8.9% of the neonates in the control group expired which was higher than the G-CSF group (P=0.06). All neonates tolerated the treatment and there was no statistically significant difference between the two groups. Conclusion: As evidenced by the obtained results, the enteral administration of G-CSF to VLBW and ELBW neonates improved feeding tolerance and it was well tolerated without any associated side effects.