Marlow, Neil, Morris, T., Brocklehurst, P., Carr, R., Cowan, F. M., Patel, N., Petrou, Stavros, Redshaw, M. E., Modi, N. and Dore, C. (2013) A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis : outcomes at 2 years. Archives of Disease in Childhood - Fetal and Neonatal Edition, Volume 98 (Number 1). F46-F53. doi:10.1136/fetalneonatal-2011-301470 ISSN 1359-2998.

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Abstract

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.

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General)
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Journal or Publication Title:	Archives of Disease in Childhood - Fetal and Neonatal Edition
Publisher:	B M J Group
ISSN:	1359-2998
Official Date:	2013
Dates:	Date Event 2013 Published
Volume:	Volume 98
Number:	Number 1
Page Range:	F46-F53
DOI:	10.1136/fetalneonatal-2011-301470
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Date of first compliant deposit:	22 December 2015
Date of first compliant Open Access:	22 December 2015

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