A trial of recombinant human granulocyte colony stimulating factor for the treatment of very low birthweight infants with presumed sepsis and neutropenia
A R Bedford Russella, A J B Emmersonb, N Wilkinsona, T Chantb, D G Sweetc, H L Hallidayc, B Hollandd, E G Daviesa
a St George's
Hospital, Blackshaw Rd, London SW17 0QT, UK, b St Mary's Hospital for Women and Children,
Whitworth Park, Manchester M13 0JH, UK, c Royal Maternity Hospital,
Belfast, Northern Ireland, d The Queen
Mother's Hospital, Glasgow, Scotland, UK
Correspondence to: Dr Bedford Russell, Neonatal Unit, St George's Hospital, Blackshaw Rd, London SW17 0QT, UK alison.bedford-russell{at}stgh-tr.sthames.nhs.uk
Accepted 29 November
2000
OBJECTIVES
The primary
objective was to investigate the safety of recombinant human
granulocyte colony stimulating factor (rhG-CSF) for the treatment of
very low birthweight infants (VLBW) with sepsis and relative
neutropenia, specifically with regard to worsening of respiratory
distress and thrombocytopenia and all cause mortality. Secondary
objectives were to evaluate duration of ventilation, intensive care,
and antibiotic use as markers of efficacy.
DESIGNNeonates
(
28 days) in intensive care, with birth weights of 500-1500 g,
absolute neutrophil count (ANC) of 5 × 109/l, and
clinical evidence of sepsis, were randomly assigned to receive either
rhG-CSF (10 µg/kg/day) administered intravenously (n = 13), or
placebo (n = 15) for a maximum of 14 days, in addition to standard
treatment and antibiotics. All adverse events, oxygenation index,
incidence of thrombocytopenia, all cause mortality, duration of
ventilation, intensive care and antibiotic treatment, and ANC recovery
were compared between the two groups.
RESULTSAdverse events
and oxygenation index were not increased by, and thrombocytopenia was
not attributable to, treatment with rhG-CSF. At 6 and 12 months
postmenstrual age, there were significantly fewer deaths in the group
receiving rhG-CSF (1/13 v 7/15;
p 0.038). There was a non-significant trend towards a reduction in duration of ventilation, intensive care, and antibiotic use in the
rhG-CSF group. There was a significantly more rapid increase in ANC in
the rhG-CSF treated babies (p < 0.001).
CONCLUSIONSIn a small
randomised placebo controlled trial in a highly selected group of
neonates, adjuvant treatment with rhG-CSF increased ANC rapidly, and no
treatment related adverse events were identified. Mortality at 6 and 12 months postmenstrual age was significantly lower in the treatment
group. A large trial investigating efficacy in a similar group of
neonates is warranted.
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Key messages
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Keywords: neutropenia; sepsis; very low birthweight infants; recombinant human granulocyte colony stimulating factor; antibiotic use; intensive care
© 2001 by Archives of Disease in Childhood
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- Recombinant human granulocyte colony stimulating factor therapy in neonates
- SM Jog
- Fetal Neonatal Ed. Online, 30 Aug 2001 [Full text]
- Re: Recombinant human granulocyte colony stimulating factor therapy in neonates
- AR Bedford Russell
- Fetal Neonatal Ed. Online, 1 Oct 2001 [Full text]
- Use of rhG-CSF for VLBW babies with presumed sepsis and neutropoenia
- Girish Gupta, et al.
- Fetal Neonatal Ed. Online, 28 Jan 2003 [Full text]
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