A randomized trial of granulocyte-macrophage colony-stimulating factor in neonates with sepsis and neutropenia

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dc.contributor.authorBilgin, K
dc.contributor.authorYaramis, A
dc.contributor.authorHaspolat, K
dc.contributor.authorTas, A
dc.contributor.authorGünbey, S
dc.contributor.authorDerman, O
dc.date.accessioned2024-04-24T17:33:11Z
dc.date.available2024-04-24T17:33:11Z
dc.date.issued2001
dc.departmentDicle Üniversitesien_US
dc.description.abstractObjectives. To determine whether adjunctive therapy with recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) could reverse sepsis-associated neonatal neutropenia and improve neonatal survival and to assess its safety compared with conventional therapy in a control group. Study Design. This prospective, randomized, controlled trial was performed in 60 infants with neutropenia and clinical signs of sepsis. A subcutaneous injection of rhGM-CSF (5 mug/kg/day) was administered to 30 of the patients for 7 consecutive days. Hematologic parameters (absolute neutrophil, eosinophil, monocyte, lymphocyte counts, and platelet number) and outcome were compared with 30 conventionally treated (control) patients. Results. Twenty-five patients from the GM-CSF-treated group and 24 from the conventionally treated group had early-onset sepsis (less than or equal to3 days' postnatal age), and the other 11 patients had late-onset sepsis (>3 days' postnatal age). There was no difference between groups in terms of birth weight; gestational age; gender; maturity; maternal age; and incidence of prolonged rupture of membranes, maternal hypertension, or severity of sepsis. All neonates tolerated GM-CSF well with no adverse reactions. The absolute neutrophil count on day 7 was significantly increased in the GM-CSF-treated group compared with the conventionally treated group: 8088 +/- 2822/mm(3) versus 2757 +/- 823/mm(3). The mean platelet count was significantly higher on days 14 in the GM-CSF-treated group compared with conventionally treated group: 266 867 +/- 55 102/mm(3) versus 229 200 +/- 52 317/mm(3). Hematologic parameters were otherwise similar between groups before treatment and on day 28. Twenty-seven neonates in the rh-GMCSF group and 21 in the control group survived to hospital discharge. The mortality rate in the rhGM-CSF group (10%) was significantly lower than in the conventionally treated group (30%). Conclusion. Treatment with rhGM-CSF is associated with an increase in absolute neutrophil, eosinophil, monocyte, lymphocyte, and platelet counts and decreased mortality in critically ill septic neutropenic neonates. These results suggest that rhGM-CSF may be effective in the treatment of neonatal sepsis with neutropenia, and further randomized trials are needed to confirm its beneficial effects.en_US
dc.identifier.endpage41en_US
dc.identifier.issn0031-4005
dc.identifier.issue1en_US
dc.identifier.pmid11134431
dc.identifier.scopus2-s2.0-0035185390
dc.identifier.scopusqualityQ1
dc.identifier.startpage36en_US
dc.identifier.urihttps://hdl.handle.net/11468/20513
dc.identifier.volume107en_US
dc.identifier.wosWOS:000166150600019
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.language.isoenen_US
dc.publisherAmer Acad Pediatricsen_US
dc.relation.ispartofPediatrics
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectRecombinant Human Granulocyte-Macrophage Colony-Stimulating Factoren_US
dc.subjectNeonatesen_US
dc.subjectNeutropeniaen_US
dc.subjectSepsisen_US
dc.titleA randomized trial of granulocyte-macrophage colony-stimulating factor in neonates with sepsis and neutropeniaen_US
dc.titleA randomized trial of granulocyte-macrophage colony-stimulating factor in neonates with sepsis and neutropenia
dc.typeArticleen_US

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