{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T14:10:39Z","timestamp":1779891039547,"version":"3.53.1"},"reference-count":36,"publisher":"BMJ","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arch Dis Child Fetal Neonatal Ed"],"accepted":{"date-parts":[[2012,2,22]]},"published-print":{"date-parts":[[2013,1]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Patients and methods<\/jats:title>\n                  <jats:p>280 babies born &lt;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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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\u00b70, 95% CI 0\u00b78 to 1\u00b72). Marginally, more children receiving GM-CSF were reported to have cough (RR 1\u00b77, 95% CI 1\u00b71 to 2\u00b76) and had signs of chronic respiratory disease (Harrison's sulcus; RR 2\u00b70, 95% CI 1\u00b70 to 3\u00b79) though this was not reflected in bronchodilator use or need for hospitalisation for respiratory disease. Overall, the rate of neurologic abnormality (7%\u20139%) was similar but mean overall developmental scores were lower than expected for gestational age.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/fetalneonatal-2011-301470","type":"journal-article","created":{"date-parts":[[2012,4,27]],"date-time":"2012-04-27T22:12:47Z","timestamp":1335564767000},"page":"F46-F53","source":"Crossref","is-referenced-by-count":27,"title":["A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years"],"prefix":"10.1136","volume":"98","clinical-trial-number":[{"clinical-trial-number":"isrctn42553489","registry":"10.18810\/isrctn"}],"author":[{"given":"Neil","family":"Marlow","sequence":"first","affiliation":[{"name":"Institute for Womens Health, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"Morris","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials unit, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Brocklehurst","sequence":"additional","affiliation":[{"name":"Institute for Women's Health, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Carr","sequence":"additional","affiliation":[{"name":"Department of Haematology, Kings College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frances M","family":"Cowan","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, Imperial College (Hammersmith Hospital), London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nishma","family":"Patel","sequence":"additional","affiliation":[{"name":"National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stavros","family":"Petrou","sequence":"additional","affiliation":[{"name":"CTU, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maggie E","family":"Redshaw","sequence":"additional","affiliation":[{"name":"Policy Research Unit in Maternal Health & Care, National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neena","family":"Modi","sequence":"additional","affiliation":[{"name":"Department of Neonatal Medicine, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Dore","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials unit, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2012,4,27]]},"reference":[{"key":"2025090221480279000_98.1.F46.1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(08)70294-1"},{"key":"2025090221480279000_98.1.F46.2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2004.09.106"},{"key":"2025090221480279000_98.1.F46.3","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.06.4451"},{"key":"2025090221480279000_98.1.F46.4","doi-asserted-by":"crossref","unstructured":"Carr R Modi N Dore C . 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