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 |