| Methods |
Single centre, controlled trial,
quasi‐randomised (alternate allocation)
stratified by growth status (SGA, AGA, LGA) |
| Participants |
60 infants with clinical signs of sepsis and neutropenia.
Definition of sepsis for recruitment: New symptons/objective clinical signs of sepsis
plus at least 1 positive blood culture, plus neutropenia.
Definition of neutropenia for recruitment: Neutrophils < 1.5 x 10(9)/l
GA <42w, BW 1100 ‐ 3500g, age < 29d.
25 treated and 24 controls had early onset sepsis.
1 centre, Turkey. Conducted January 1994 to March 1995. |
| Interventions |
30 infants received 5 mcg/kg GM‐CSF SC daily for 7d
30 infants were controls (no placebo used).
(Leucomax, Novartis, UK) |
| Outcomes |
Mortality to discharge.
All surviving infants were discharged on or before day 21 from admission.
All neonates tolerated GM‐CSF well with no adverse reactions. |
| 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? |
High risk |
C ‐ Inadequate |
