| Methods |
Multi‐centre, randomised controlled trial, stratified by growth status (AGA or SGA) |
| Participants |
75 infants, BW 480 ‐ 1760g, GA < 32w, age < 72h. 2 centres in UK. Dates not given |
| Interventions |
36 infants received 10 mcg/kg GM‐CSF (Leucomax, Novartis, UK) SC daily for 5d, 39 infants were controls (no placebo used) |
| Outcomes |
Symptomatic blood culture positive sepsis to 14d. Mortality to 28d. Mortality to 6m.
During GM‐CSF administration there was no local toxicity at injection sites, no evidence of increased irritability, which might suggest bone pain, and no difference from controls in terms of pyrexia or weight change. There was no significant difference between the groups in oxygen requirement during treatment or during the subsequent week. Similar numbers of treated and control infants were oxygen‐dependent at 28 days postnatal age and 36 weeks post‐menstrual age. No gastrointestinal toxicity was observed, in particular necrotising enterocolitis was suspected or confirmed in 2 infants in each treatment group. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
