PT - JOURNAL ARTICLE AU - Neil Marlow AU - Timothy Morris AU - Peter Brocklehurst AU - Robert Carr AU - Frances M Cowan AU - Nishma Patel AU - Stavros Petrou AU - Maggie E Redshaw AU - Neena Modi AU - Caroline Dore TI - A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years AID - 10.1136/fetalneonatal-2011-301470 DP - 2013 Jan 01 TA - Archives of Disease in Childhood - Fetal and Neonatal Edition PG - F46--F53 VI - 98 IP - 1 4099 - http://fn.bmj.com/content/98/1/F46.short 4100 - http://fn.bmj.com/content/98/1/F46.full SO - Arch Dis Child Fetal Neonatal Ed2013 Jan 01; 98 AB - Objective The authors performed a randomised trial in very preterm small-for-gestational age (SGA) babies to determine if prophylaxis with granulocyte-macrophage colony-stimulating factor (GM-CSF) improves outcomes (the PROGRAMS trial). Despite increased neutrophil counts following GM-CSF, the authors reported no significant difference in neonatal sepsis-free survival. Patients and methods 280 babies born <31 weeks of gestation and SGA were entered into the trial. Outcome was determined at 2 years to determine neurodevelopmental and general health outcomes, including economic costs. Results The authors found no significant differences in health outcomes or health and social care costs between the trial groups. In the GM-CSF arm, 87 of 134 (65%) babies survived to 2 years without severe disability compared with 87 of 131 (66%) controls (RR: 1·0, 95% CI 0·8 to 1·2). Marginally, more children receiving GM-CSF were reported to have cough (RR 1·7, 95% CI 1·1 to 2·6) and had signs of chronic respiratory disease (Harrison's sulcus; RR 2·0, 95% CI 1·0 to 3·9) though this was not reflected in bronchodilator use or need for hospitalisation for respiratory disease. Overall, the rate of neurologic abnormality (7%–9%) was similar but mean overall developmental scores were lower than expected for gestational age. Conclusions The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse outcomes at 2 years of age. The apparent excess of developmental impairment in the entire PROGRAMS cohort, without corresponding increase in neurological abnormality, may represent diffuse brain injury attributable to intrauterine growth restriction.