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A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: childhood outcomes at 5 years
  1. Neil Marlow1,
  2. Timothy Morris2,
  3. Peter Brocklehurst1,
  4. Robert Carr3,
  5. Frances Cowan4,
  6. Nishma Patel5,
  7. Stavros Petrou6,
  8. Margaret Redshaw7,
  9. Neena Modi4,
  10. Caroline J Doré2
  1. 1UCL Institute for Women's Health, University College London, London, UK
  2. 2MRC Clinical Trials Unit, University College London, London, UK
  3. 3Department of Haematology, Guy's and St Thomas’ Hospital, King's College London, London, UK
  4. 4Section of Neonatal Medicine, Department of Medicine, Chelsea & Westminster campus, Imperial College London, London, UK
  5. 5Department of Applied Health Research, University College London, London, UK
  6. 6Warwick Medical School, University of Warwick, Coventry, UK
  7. 7National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK
  1. Correspondence to : Professor Neil Marlow, UCL Institute for Women's Health, 74 Huntley Street, London WC1E 6AU, UK; n.marlow{at}ucl.ac.uk

Abstract

Objective We 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). GM-CSF was associated with improved neonatal neutrophil counts, but no change in other neonatal or 2-year outcomes. As subtle benefits in outcome may not be ascertainable until school age we performed an outcome study at 5 years.

Patients and methods 280 babies born at 31 weeks of gestation or less and SGA were entered into the trial. Outcomes were assessed at 5 years to determine neurodevelopmental and general health status and educational attainment.

Results We found no significant differences in cognitive, general health or educational outcomes between 83 of 106 (78%) surviving children in the GM-CSF arm compared with 81 of 110 (74%) in the control arm. Mean mental processing composite (equivalent to IQ) at 5 years were 94 (SD 16) compared with 95 (SD 15), respectively (difference in means −1 (95%CI −6 to 4), and similar proportions were in receipt of special educational needs support (41% vs 35%; risk ratio 1.2 (95% CI 0.8 to 1.9)). Performance on Kaufmann-ABC subscales and components of NEPSY were similar. The suggestion of worse respiratory outcomes in the GM-CSF group at 2 years was replicated at 5 years.

Conclusions The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse neurodevelopmental, general health or educational outcomes at 5 years.

Trial registration number ISRCTN42553489.

  • Child Psychology
  • Haematology
  • Neonatology
  • Neurodevelopment

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/archdischild-2014-307410

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