Comparison of Two Regimens of RhG-CSF in Neutropenic Neonatal Septicemia: A Randomized Clinical Trial
Considering the 50% mortality rate of neonatal septicemia associated with neutropenia and increasing resistance to antibiotics, simultaneous antibiotic therapy strategies are becoming more important. However, few studies have been performed to evaluate effectiveness of RhG-CSF in the treatment of neutropenia in neonates. This randomized clinical trial was performed on 40 neutropenic neonates with septicemia who were hospitalized in Vali-e-Asr and Mirza Koochak Khan Hospitals (Tehran, Iran). The neonates were randomly divided into two equal groups RhG-CSF was administered as a subcutaneous single dose of 10μg/kg/s.c. to neonates in group A and as 10μg/kg/s.c./day once daily for 3 days to neonates in group B. CBC and differential count was checked 6, 24 and 48 hours after the last dose. There was no significant difference in mean birth weight, gender, age, and risk factors between two groups. Neutropenia was improved 48 hours after the last dose, whilst there was no significant statistical difference between two groups (P>0.05). The final outcome including death, duration of hospitalization and duration of antibiotics therapy after RhG-CSF administration did not differ between two groups (P>0.05). The results of this study showed that administration of a single dose of RhG-CSF (10μg/kg) was effective in treating neonatal septicemic neutropenia.
Stoll BJ. Infections of neonatal infant. In: Kliegman RM, Behrman RE, Jenson HB, Stanton BF, editors. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, Pa: Saunders Elsevier; 2007. p. 794-8.
Manroe BL, Weinberg AG, Rosenfeld CR, Browne R. The neonatal blood count in health and disease. I. Reference values for neutrophilic cells. J Pediatr 1979;95(1):89-98.
Mcelrath TF. Preeclampsia and related conditions. In: Cloherty JP, Eichenwald EC, Stark, editors. Manual of Neonatal Care. 6th ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2008. p. 33.
Polin RA, Parravicini E, Regan JA, Taeusch HW. Bacterial sepsis and meningitis. In: Taesch HW, Ballard RA, Gleason CA, editors. Avery's Diseases of the Newborn. 8th ed. Philadelphia, PA: Elsevier Saunders; 2005. p. 551-7.
Roberts RL, Szelc CM, Scates SM, Boyd MT, Soderstrom KM, Davis MW, Glaspy JA. Neutropenia in an extremely premature infant treated with recombinant human granulocyte colony-stimulating factor. Am J Dis Child 1991;145(7):808-12.
Kocherlakota P, La Gamma EF. Preliminary report: rhGCSF may reduce the incidence of neonatal sepsis in prolonged preeclampsia-associated neutropenia. Pediatrics 1998;102(5):1107-11.
Kocherlakota P, La Gamma EF. Human granulocyte colony-stimulating factor may improve outcome attributable to neonatal sepsis complicated by neutropenia.Pediatrics 1997;100(1):E6.
La Gamma EF, Alpan O, Kocherlakota P. Effect of granulocyte colony-stimulating factor on preeclampsiaassociated neonatal neutropenia. J Pediatr 1995;126(3):457-9.
Carr R, Modi N, Doré C. G-CSF and GM-CSF for treatingor preventing neonatal infections. Cochrane Database SystRev 2003;(3):CD003066.
Ahmad M, Fleit HB, Golightly MG, La Gamma EF. In vivo effect of recombinant human granulocyte colonystimulating factor on phagocytic function and oxidative burst activity in septic neutropenic neonates. Biol Neonate 2004;86(1):48-54.
Lee C, Custer JW, Rau RE. Drug doses. In: Custer JW, Rau RE, editors. The Harriet Lane Handbook. 18th ed. Philadelphia, Pa: Elsevier Mosby; 2009. p. 831-2.
Eichenwald EC. Care of the extremely low birth weight infant. In: Taesch HW, Ballard RA, Gleason CA, editors. Avery's Diseases of the Newborn. 8th ed. Philadelphia, PA: Elsevier Saunders; 2005. p. 410-7.
Luchtman-Jones LL, Schwartz AL, Wilson DB. Hematologic problems in the fetus and neonate. In: Martin RJ, Fanaroff AA, Walsh MC, editors. Fanaroff and Martin's NeonatalPerinatal Medicine Diseases of the Fetus and Infant. 8th ed. Philadelphia: Mosby Elsevier; 2006. p. 1310-4.
Cairo MS, Christensen R, Sender LS, Ellis R, Rosenthal J, van de Ven C, Worcester C, Agosti JM. Results of a phase I/II trial of recombinant human granulocyte-macrophage colony-stimulating factor in very low birthweight neonates: significant induction of circulatory neutrophils, monocytes, platelets, and bone marrow neutrophils. Blood 1995;86(7):2509-15.
Gillan ER, Christensen RD, Suen Y, Ellis R, van de Ven C, Cairo MS. A randomized, placebo-controlled trial of recombinant human granulocyte colony-stimulating factor administration in newborn infants with presumed sepsis: significant induction of peripheral and bone marrow neutrophilia. Blood 1994;84(5):1427-33.
Modi N, Carr R. Promising stratagems for reducing the burden of neonatal sepsis. Arch Dis Child Fetal Neonatal Ed 2000;83(2):F150-3.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.