This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My File Cabinet
Right arrow Download to citation manager
Right arrowRequest Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via CrossRef
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Schibler, K. R.
Right arrow Articles by Thompson, D. D.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Schibler, K. R.
Right arrow Articles by Thompson, D. D.
Related Collections
Right arrow Premature & Newborn
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us   Add to Digg   Add to Facebook   Add to Reddit   Add to Technorati   Add to Twitter  
What's this?

PEDIATRICS Vol. 102 No. 1 July 1998, pp. 6-13

A Randomized, Placebo-Controlled Trial of Granulocyte Colony-stimulating Factor Administration to Newborn Infants With Neutropenia and Clinical Signs of Early-onset Sepsis

Received Jul 31, 1997; accepted Jan 19, 1998.

Kurt R. Schibler, Karen A. Osborne, Ling Y. Leung, Trong V. Le, Shawna I. Baker, and Dixie D. Thompson

From the Department of Pediatrics, Division of Neonatology, and the Clinical Research Center, University of Utah School of Medicine, Salt Lake City, Utah.

Objective.  To determine whether recombinant human granulocyte colony-stimulating factor (G-CSF) administration: 1) accelerates production of neutrophils; 2) increases bone marrow stored and precursor neutrophils; and 3) is safe in newborn infants with neutropenia and clinical signs of early-onset sepsis.

Study Design.  We randomized 20 infants with neutropenia and clinical signs of early-onset sepsis in the first 3 days of life to receive G-CSF (10 µg/kg/d) or placebo for 3 days. Entry criteria included neutropenia as defined by Manroe criteria, an elevated immature to total neutrophil ratio [(I/T) >= 0.25], and a requirement for ventilatory support. Cultures were obtained and antibiotics initiated on all study infants. Circulating absolute neutrophil count (ANC), I/T ratio, bone marrow neutrophil storage pool (NSP) and neutrophil proliferative pool (NPP), and plasma G-CSF concentrations were evaluated. Also, severity of illness as determined using the Score for Neonatal Acute Physiology (SNAP), morbidity, and mortality were recorded.

Results.  Circulating ANC increased in both G-CSF and placebo recipients by day 1. Also, the I/T neutrophil ratio decreased in both G-CSF and placebo recipients. There were no significant differences in the ANC or I/T ratio between the two groups during the study period. Similarly, bone marrow NSP and NPP did not differ between G-CSF and placebo recipients at study entry or day 2. No differences were observed in the secondary outcome measures including severity of illness, morbidity, and mortality.

Conclusions.  Administration of recombinant G-CSF to infants with neutropenia and clinical signs of early-onset sepsis did not increase circulating ANC, or bone marrow NSP and NPP compared with placebo. No differences were observed between G-CSF and placebo recipients in severity of illness, morbidity, or mortality. No adverse effects of G-CSF administrations were noted.

Key words: granulocyte colony-stimulating factor, neutropenia, early-onset sepsis, absolute neutrophil count, neutrophil storage pool, neutrophil proliferative pool.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Facebook Facebook   Add to Reddit Reddit   Add to Technorati Technorati   Add to Twitter Twitter    What's this?


This article has been cited by other articles:


Home page
 NeoReviewsHome page
A. Maheshwari and R. D. Christensen
Neutropenia in the Neonatal Intensive Care Unit
NeoReviews, October 1, 2004; 5(10): e431 - e443.
[Full Text] [PDF]

Home page
 Arch. Dis. Child. Fetal Neonatal Ed.Home page
A R B. Russell, A J B Emmerson, N Wilkinson, T Chant, D G Sweet, H L Halliday, B Holland, and E G Davies
A trial of recombinant human granulocyte colony stimulating factor for the treatment of very low birthweight infants with presumed sepsis and neutropenia
Arch. Dis. Child. Fetal Neonatal Ed., May 1, 2001; 84(3): 172F - 176.
[Abstract] [Full Text]

Home page
 PediatricsHome page
E. Miura, R. S. Procianoy, C. Bittar, C. S. Miura, M. S. Miura, C. Mello, and R. D. Christensen
A Randomized, Double-Masked, Placebo-Controlled Trial of Recombinant Granulocyte Colony-Stimulating Factor Administration to Preterm Infants With the Clinical Diagnosis of Early-Onset Sepsis
Pediatrics, January 1, 2001; 107(1): 30 - 35.
[Abstract] [Full Text]

Home page
 PediatricsHome page
K. Haspolat, S. Günbey, and O. Derman
A Randomized Trial of Granulocyte-Macrophage Colony-Stimulating Factor in Neonates With Sepsis and Neutropenia
Pediatrics, January 1, 2001; 107(1): 36 - 41.
[Abstract] [Full Text]

Home page
 Arch. Dis. Child. Fetal Neonatal Ed.Home page
N. Modi and R. Carr
Promising stratagems for reducing the burden of neonatal sepsis
Arch. Dis. Child. Fetal Neonatal Ed., September 1, 2000; 83(2): 150F - 153.
[Full Text]

Home page
 PediatricsHome page
A. Funke, R. Berner, B. Traichel, D. Schmeisser, J. U. Leititis, and C. M. Niemeyer
Frequency, Natural Course, and Outcome of Neonatal Neutropenia
Pediatrics, July 1, 2000; 106(1): 45 - 51.
[Abstract] [Full Text]

Home page
 PediatricsHome page
D. A. Calhoun, M. Lunøe, Y. Du, A. D. Hutson, M. Veerman, and R. D. Christensen
Granulocyte Colony-Stimulating Factor Serum and Urine Concentrations in Neutropenic Neonates Before and After Intravenous Administration of Recombinant Granulocyte Colony-Stimulating Factor
Pediatrics, February 1, 2000; 105(2): 392 - 397.
[Abstract] [Full Text]

Home page
 Arch Pediatr Adolesc MedHome page
C. Sreenan and H. Osiovich
Myeloid Colony-Stimulating Factors: Use in the Newborn
Arch Pediatr Adolesc Med, September 1, 1999; 153(9): 984 - 988.
[Abstract] [Full Text] [PDF]

Home page
 PediatricsHome page
K. Yasui, K. Agematsu, A. Komiyama;, K. R. Schibler, K. A. Osborne, L. Y. Leung, T. V. Le, S. I. Baker, and D. D. Thompson
Recombinant Human Granulocyte Colony-stimulating Factor Therapy for Sepsis in Infants With Neutropenia
Pediatrics, June 1, 1999; 103(6): 1310 - 1310.
[Full Text]

Home page
 PediatricsHome page
R. Carr, N. Modi, C. J. Doré, R. El-Rifai, and D. Lindo
A Randomized, Controlled Trial of Prophylactic Granulocyte-Macrophage Colony-Stimulating Factor in Human Newborns Less Than 32 Weeks Gestation
Pediatrics, April 1, 1999; 103(4): 796 - 802.
[Abstract] [Full Text]