| Methods |
Single centre, randomised double‐masked placebo controlled trial, not stratified. |
| Participants |
44 infants with clinical diagnosis of sepsis.
Definition of sepsis for recruitment: >/= 3 objective clinical signs of sepsis plus >/= 1 laboratory criterion for sepsis plus blood culture taken and antibiotics commenced.
Definition of neutropenia: neutrophils < 1.5 x 10(9)/l (not used as an entry criterion.
GA < 37w, BW 500 ‐ 2000g, age <5d.
1 centre, Brazil. Conducted July 1996 to July 1997. |
| Interventions |
22 infants received 10 mcg/kg G‐CSF IV daily for 3d,
22 infants received placebo (identical volume, visually indistinguishable).
(Amgen, Thousand Oaks, CA, US) |
| Outcomes |
All cause mortality within 30d.
Mortality to discharge. Nosocomial infections during the 14d after the final dose.
We observed no adverse effects of G‐CSF. |
| Notes |
Trial was stopped early due to overwhelming evidence of non efficacy. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
