ISRCTN A multicentre single blind randomised controlled trial of

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                                   ISRCTN 42553489
 A multicentre, single-blind, randomised, controlled trial of PROphylactic GRAnulocyte
 Macrophage colony stimulating factor (GM-CSF) to reduce Sepsis in preterm neonates

Issue No 1    Summer 2001
                                                       University College Hospital, London
                                                               Dr Jane Hawdon
  We are delighted that the following                  Wexham Park Hospital, Slough
centres now have Local Research Ethics                         Dr Ros Jones
   Committee approval to take part in          Overseas Centres:
             PROGRAMS:                         Aglaia Kyriakou Childrens Hospital, Athens
UK Centres:                                                    Dr Heracles Dellagrammaticas

      Chelsea & Westminster Hospital, London   and more centres are in the pipeline to receive Local
               Dr Dominique Acolet             Research Ethics Committee approval shortly.
      Guys & St Thomas’ Hospital, London
               Dr Judy Rissik
      Hammersmith & Queen Charlotte’s
      Hospital, London
               Dr Neena Modi
      Hillingdon Hospital, Middlesex
               Dr Michelle Cruwys                 The following centres have already recruited
      Homerton Hospital, London
               Dr Elia Maalouf
                                                              infants to the study
      Ipswich Hospital, Ipswich                       GUY’S & ST THOMAS’
               Dr Kevin O’Neill                 HAMMERSMITH & QUEEN CHARLOTTE’S
      Liverpool Womens’ Hospital, Liverpool                 IPSWICH
               Professor Michael Weindling
      Medway Maritime Hospital, Gillingham            MEDWAY MARITIME
               Dr Bhavdeep Jani                        ROSIE, CAMBRIDGE
      Ninewells Hospital, Dundee                     ROYAL SUSSEX COUNTY
               Dr Peter Fowlie                      ST MARY’S MANCHESTER
      Norfolk & Norwich Hospital, Norwich            WEXHAM PARK, SLOUGH
               Dr Julian Eason
      Northwick Park Hospital, London              Thank you and keep up the good work!
               Dr Richard Nicholl
      Queen Elizabeth Hospital, Woolwich
               Dr Bushra Al-Rubeyi
      Rosie Hospital, Cambridge
               Dr Amanda Ogilvy-Stuart
      Royal Sussex County Hospital, Brighton   A total of 320 babies need to be recruited to
               Dr Fiona Weir                   PROGRAMS by summer 2003. We are pleased
      Singleton Hospital, Swansea              to say that recruitment is now taking off.
               Dr Jean Matthes
      St Mary’s Hospital, Manchester           If you can think of anything that we can do to
               Dr Anthony Emmerson             help recruitment at your centre, please let us
      St Mary’s Hospital, Portsmouth           know. Or if you are successfully recruiting and
               Dr Richard Thwaites             have some useful tips we can pass on to other
      St Michael’s Hospital, Bristol           centres, we would love to hear from you. We can
               Dr Pamela Cairns
                                               then include them in the next newsletter!
                                                       Can we join PROGRAMS and INIS?
This was held at the Royal College of
Paediatrics and Child Health in London on              Yes. Although both trials are looking at neonatal
February 5th 2001and was CPD approved..                sepsis, there is only a small overlap in the babies
Approximately 30 collaborators managed to              eligible for each trial. Babies eligible for
attend despite industrial action by the London         PROGRAMS are preterm and small for
Underground.                                           gestational age with no evidence of acute sepsis.
The meeting covered the scientific background          Babies eligible for INIS are any size or gestation
to the trial, trial design and the data collection     who have acute sepsis.
process. We looked at the complexities of              So, if a PROGRAMS baby develops sepsis, can
setting up a randomised trial and the use of           they be entered into INIS?
statistics in randomised trials. A presentation on
                                                       No. Both trials are measuring outcomes at age 2
cerebral ultrasound was given and at the end of
                                                       years and including PROGRAMS babies in INIS
the day a discussion session was held on the
                                                       (if IVIG works!) will weaken the power of
issues surrounding informed consent in neonatal
                                                       PROGRAMS to be able to demonstrate an effect
                                                       of prophylactic GM-CSF.
A further Collaborators Meeting will be held at
the Medical Research Council, Clinical Trials          Can we still join the study if all our premature
Unit in London on July 18th with more meetings         babies routinely receive antibiotics?
planned for later in the year.
                                                       Yes. All other aspects of neonatal care are left to
Frequently asked questions about PROGRAMS
                                                       the discretion of the attending clinicians.
                                                       However, do not routinely prescribe antibiotics to
How is the purchase of GM-CSF to be funded?            babies allocated no GM-CSF and not to babies
The Government Statement of Partnership HSG            allocated GM-CSF. If this happens, we will not
(97) 32 (May 1997) states: “This statement of          be able to determine the effects of GM-CSF
partnership guarantees NHS support for R&D             fairly.
funded by Research Charities and Universities,
in all but exceptional circumstances, provided         If centres have different ways of trying to
they in turn take certain steps to ensure that their   prevent or treat sepsis, will the results of the
R&D is compatible with the operation of the            trial not be influenced by these differences?
NHS”. A Trust should not refuse to host R&D            No, there is balance between both arms of the
due to concern over treatment costs. In the case       trial in each centre. This means that at the end of
of PROGRAMS, the costs are relatively low.             the trial there will be similar numbers of babies
What is the purpose of the £150 per baby               who have been allocated GM-CSF and babies
payment?                                               allocated no GM-CSF in each centre. This will
                                                       control for the effect of any differences between
Action Research acknowledge the importance of          centres. This does not mean that allocation is not
the largely under-recognised input of                  randomised, you will not be able to predict the
collaborating centres and have provided the trial      next allocation, but overall, there will be balance
organisers with £150 per baby recruited. This is       between the two arms of the trial.
intended as a contribution to help support
research within participating units. We hope that      Can we enter a baby into the study at any time
this will set a precedent for other grant awarding     day or night?
bodies. Centres should not be required to use          Yes. The randomisation service is a 24 hour
this payment to cover treatment costs.                 service, 7 days a week.

If you require any further information please don’t hesitate to contact:
Anne Smith
Programs Administrator
National Perinatal Epidemiology Unit, Institute of Health Sciences,
Old Road, Headington, Oxford, OX3 7LF
Tel: 01865 226762 Fax: 01865 227002
or one of the Principal Investigators