Granulocyte-macrophage colony stimulating factor administered as prophylaxis for reduction of sepsis in extremely preterm, small for gestational age neonates (the PROGRAMS trial): a single-blind, multicentre, randomised controlled trial

@article{Carr2009GranulocytemacrophageCS,
  title={Granulocyte-macrophage colony stimulating factor administered as prophylaxis for reduction of sepsis in extremely preterm, small for gestational age neonates (the PROGRAMS trial): a single-blind, multicentre, randomised controlled trial},
  author={Robert Carr and Peter Brocklehurst and Caroline J. Dor{\'e} and Neena Modi},
  journal={The Lancet},
  year={2009},
  volume={373},
  pages={226-233}
}
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122 Citations
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122 Citations

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Recombinant human granulocyte colony-stimulating factor in preterm neonates with sepsis and relative neutropenia: a randomized, single-blind, non-placebo-controlled trial.
TLDR
Preterm neonates with sepsis and neutropenia treated with rhG-CSF adjunctive therapy have decreased all-cause mortality at discharge and a quicker recovery of their total leucocyte and ANC.
A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years
TLDR
The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse outcomes at 2 years of age, and the apparent excess of developmental impairment in the entire PROGRAMS cohort may represent diffuse brain injury attributable to intrauterine growth restriction.
A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: childhood outcomes at 5 years
TLDR
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.
In Vivo Effect of Recombinant Human Granulocyte Colony-Stimulating Factor on Neutrophilic Expression of CD11b in Septic Neonates: A Randomized Controlled Trial
TLDR
G-CSF administration as an adjuvant therapy for neonatal septicemia, whether neutropenic or not, improves neutrophilic count and function and contributed to early healing from sepsis.
Effectiveness of Granulocyte Colony‐Stimulating Factor in Hospitalized Infants with Neutropenia
TLDR
G‐CSF treatment decreased the time to hematologic recovery but was associated with increased odds of secondary sepsis and mortality in neutropenic infants, and G‐ CSF should not routinely be used for infants with neutropenia.
Role of G-CSF GM-CSF in the management of infections in preterm newborns: an update.
Late-onset sepsis in preterm infants: update on strategies for therapy and prevention
TLDR
Promising strategies to prevent late-onset sepsis include oral lactoferrin, and pathogen-specific monoclonal antibodies but more evidence is required to make practice recommendations.
Neonatal neutropenia: what diagnostic evaluation is needed and when is treatment recommended?
The role of colony stimulating factors and immunoglobulin in the prevention and treatment of neonatal infection
  • R. Carr
  • Medicine
    Archives of Disease in Childhood: Fetal and Neonatal Edition
  • 2012
TLDR
Both intravenous immunoglobulin (IvIg) replacement and CSFs have now been extensively investigated as adjunctive treatment for established SI or prophylaxis to prevent late onset newborn sepsis.
Neonatal Sepsis - A Study of Predisposing Factors and Causative Organisms
Original Research Article Neonatal sepsis is the most common cause of neonatal mortality and morbidity. Studies have recorded an incidence of neonatal sepsis, varying between 11 and 24.5 per 1000…
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References

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TLDR
Five-day prophylactic GM-CSF completely abolishes postnatal neutropenia and sepsis-induced neutrophil number in preterm neonates at high risk of sepsIS, and so removes an important risk factor for sepsi and septic-related mortality.
Comparison of recombinant granulocyte colony-stimulating factor, recombinant human granulocyte-macrophage colony-stimulating factor and placebo for treatment of septic preterm infants
TLDR
The neutrophil count in the rG- CSF-treated group increased significantly faster than that in the placebo or rhuGM-CSF group, and Mortality and neonatal intensive care unit morbidity was not significantly different between the groups.
Results of a phase I/II trial of recombinant human granulocyte- macrophage colony-stimulating factor in very low birthweight neonates: significant induction of circulatory neutrophils, monocytes, platelets, and bone marrow neutrophils
TLDR
Recombinant murine GM-CSF administration to neonatal rats has resulted in neutrophilia, increased neutrophil production, and increased survival of pups during experimental Staphylococcus aureus sepsis, and there was no evidence of grade III or IV toxicity in this study.
A randomized trial of granulocyte-macrophage colony-stimulating factor in neonates with sepsis and neutropenia.
TLDR
Treatment with rhGM-CSF is associated with an increase in absolute neutrophil, eosinophil, monocyte, lymphocyte, and platelet counts and decreased mortality in critically ill septic neutropenic neonates, and further randomized trials are needed to confirm its beneficial effects.
A randomized, double-blind, placebo-controlled trial of prophylactic recombinant human granulocyte-macrophage colony-stimulating factor to reduce nosocomial infections in very low birth weight neonates.
Prophylactic granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor decrease febrile neutropenia after chemotherapy in children with cancer: a meta-analysis of randomized controlled trials.
TLDR
CSFs were associated with a 20% reduction in febrile neutropenia and shorter duration of hospitalization; however, CSFs did not reduce infection-related mortality.
Haemopoietic colony stimulating factors for preterm neonates
  • R. Carr, N. Modi
  • Medicine
    Archives of disease in childhood. Fetal and neonatal edition
  • 1997
TLDR
Mortality from sepsis declined steadily until the early 1980s, but since then it has remained constant at near 15%, and a plateau of mortality most likely reflects the poor host defences of immature, preterm neonates.
Granulocyte Colony-Stimulating Factor and Granulocyte-Macrophage Colony-Stimulating Factor Have Differential Effects on Neonatal and Adult Neutrophil Survival and Function
TLDR
The antiapoptotic X chromosome–linked inhibitor of apoptosis protein is up-regulated in neonates compared with adults and may mediate their differential spontaneous apoptosis, as responses differ from those seen in adults.
Preliminary Report: rhG-CSF May Reduce the Incidence of Neonatal Sepsis in Prolonged Preeclampsia-associated Neutropenia
TLDR
rhG-CSF increases the ANC significantly and reduces the incidence of neonatal sepsis in critically ill ventilated neonates with prolonged preeclampsia-associated neutropenia when compared with conventional therapy and a future prospective, randomized, and blinded trial is needed to validate the beneficial effects of prophylactic rhG- CSF therapy.
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TLDR
There is no evidence that the addition of G- CSF or GM-CSF to antibiotic therapy in preterm infants with suspected systemic infection reduces immediate all cause mortality, and seven treatment studies were small, the largest recruiting only 60 infants.
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