Evidence map›Paper›PMID 25922190›Full record

Trial reportArchives of disease in childhood. Fetal and neonatal edition2015

A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: childhood outcomes at 5 years.

Neil Marlow, Timothy Morris, Peter Brocklehurst, Robert Carr, Frances Cowan, Nishma Patel, Stavros Petrou, Margaret Redshaw, Neena Modi, Caroline J Doré

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. IRF3 Signaling within the Mouse Stroma Influences Sepsis Pathogenesis.Journal of immunology (Baltimore, Md. : 1950) · 2021
    Article
  5. Review
  6. Neonatal Sepsis.Sisli Etfal Hastanesi tip bulteni · 2020
    Review
  7. Article
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Neil MarlowUCL Institute for Women's Health, University College London, London, UK.
Timothy MorrisMRC Clinical Trials Unit, University College London, London, UK.
Peter BrocklehurstUCL Institute for Women's Health, University College London, London, UK.
Robert CarrDepartment of Haematology, Guy's and St Thomas' Hospital, King's College London, London, UK.
Frances CowanSection of Neonatal Medicine, Department of Medicine, Chelsea & Westminster campus, Imperial College London, London, UK.
Nishma PatelDepartment of Applied Health Research, University College London, London, UK.
Stavros PetrouWarwick Medical School, University of Warwick, Coventry, UK.
Margaret RedshawNational Perinatal Epidemiology Unit, University of Oxford, Oxford, UK.
Neena ModiSection of Neonatal Medicine, Department of Medicine, Chelsea & Westminster campus, Imperial College London, London, UK.
Caroline J DoréMRC Clinical Trials Unit, University College London, London, UK.

Funding

Department of HealthMedical Research Council G0501681Medical Research Council G0700452Wellcome Trust
6 · The paper itself

Abstract

objectiveWe 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

methods280 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.

resultsWe 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.

conclusionsThe 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.

Indexed as

Infant, Extremely PrematureInfant, Small for Gestational AgeChild DevelopmentFemaleGranulocyte-Macrophage Colony-Stimulating FactorHematologic AgentsHumansInfant, NewbornLeukocyte CountMaleNeuropsychological TestsNeutrophilsOutcome Assessment, Health CareSepsisTimeGranulocyte-Macrophage Colony-Stimulating FactorHematologic AgentsChild PsychologyHaematologyNeonatologyNeurodevelopment

Identifiers

PMID25922190
PMCPMC4484494

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.