A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years
<p><strong>Objective</strong> 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 neutrop...
| Main Authors: | , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
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BMJ Publishing Group
2012
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| _version_ | 1826312637202300928 |
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| author | Marlow, N Morris, T Brocklehurst, P Carr, R Cowan, FM Patel, N Petrou, S Redshaw, M Modi, N Dore, C |
| author_facet | Marlow, N Morris, T Brocklehurst, P Carr, R Cowan, FM Patel, N Petrou, S Redshaw, M Modi, N Dore, C |
| author_sort | Marlow, N |
| collection | OXFORD |
| description | <p><strong>Objective</strong> 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.</p>
<p><strong>Patients and methods</strong> 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.</p>
<p><strong>Results</strong> 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.</p>
<p><strong>Conclusions</strong> 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.</p> |
| first_indexed | 2024-03-06T20:47:59Z |
| format | Journal article |
| id | oxford-uuid:3692d55d-d6fd-4910-9663-72790620a051 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-04-23T08:23:42Z |
| publishDate | 2012 |
| publisher | BMJ Publishing Group |
| record_format | dspace |
| spelling | oxford-uuid:3692d55d-d6fd-4910-9663-72790620a0512024-04-10T10:03:19ZA randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 yearsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:3692d55d-d6fd-4910-9663-72790620a051EnglishSymplectic Elements at OxfordBMJ Publishing Group2012Marlow, NMorris, TBrocklehurst, PCarr, RCowan, FMPatel, NPetrou, SRedshaw, MModi, NDore, C<p><strong>Objective</strong> 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.</p> <p><strong>Patients and methods</strong> 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.</p> <p><strong>Results</strong> 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.</p> <p><strong>Conclusions</strong> 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.</p> |
| spellingShingle | Marlow, N Morris, T Brocklehurst, P Carr, R Cowan, FM Patel, N Petrou, S Redshaw, M Modi, N Dore, C A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years |
| title | A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years |
| title_full | A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years |
| title_fullStr | A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years |
| title_full_unstemmed | A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years |
| title_short | A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years |
| title_sort | randomised trial of granulocyte macrophage colony stimulating factor for neonatal sepsis outcomes at 2 years |
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