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. 2003 Jul 21;2003(3):CD003066. doi: 10.1002/14651858.CD003066

Drossou‐Agakidou '98.

Methods Single centre randomised controlled trial, not stratified
Participants 35 infants with proven sepsis 
 and neutrophils < 5 x 10(9)/l 
 Definition of sepsis for recruitment: Presence of objective clinical signs indicative of sepsis plus at least 2 laboratory findings indicative of sepsis plus a positive blood culture. 
 GA 24 ‐ 37w, BW 720 ‐ 2940g, age < 28d. 
 1 centre, Greece. Dates not given.
Interventions 19 infants received 10 mcg/kg G‐CSF SC daily for 3d, 
 16 infants were controls (no placebo used). 
 (Granulokine, Roche)
Outcomes Mortality within 10d of sepsis onset. 
 G‐CSF was well tolerated and no short term adverse effects were observed.
Notes All infants included had positive blood cultures. Was recruitment and randomisation delayed until culture positive sepsis confirmed? Were infants with negative blood cultures excluded post randomisation? If so it is not stated and no information is provided on their outcomes.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear