|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Prophylactic granulocyte-macrophage colony-stimulating factor (GM-CSF) to reduce sepsis in preterm neonates |
| ISRCTN | ISRCTN42553489 |
| DOI | 10.1186/ISRCTN42553489 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Prophylactic granulocyte-macrophage colony-stimulating factor (GM-CSF) to reduce sepsis in preterm neonates |
| Scientific title | Prophylactic granulocyte-macrophage colony-stimulating factor (GM-CSF) to reduce sepsis in preterm neonates: a randomised controlled trial |
| Acronym | PROGRAMS |
| Serial number at source | SP3558 |
| Study hypothesis |
To estimate the economic efficiency of administering prophylactic granulocytic-macrophage colony stimulating factor to preterm neonates at high risk of sepsis.
Please note that as of 21/01/2009 this record was updated. All update details can be found under the relevant field with the above update date. |
| Lay summary | |
| Ethics approval | Added 21/01/2009: NHS Executive South East MREC gave approval on the 27th January 2000 (ref: 99/85) |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Sepsis |
| Participants - inclusion criteria | Babies are eligible for PROGRAMS if they are less than or equal to 31 completed weeks gestational age and small for gestational age (i.e. below 10th centile for birthweight) and within 72 hours of birth. |
| Participants - exclusion criteria |
Added 21/01/2009:
1. Immediately life threatening congenital abnormality 2. Evidence of early onset sepsis (maternal pyrexia greater than 38.0°C on two consecutive occasions during labour) |
| Anticipated start date | 01/09/2001 |
| Anticipated end date | 01/09/2005 |
| Status of trial | Completed |
| Patient information material | Can be found at http://www.npeu.ox.ac.uk/downloads/programs/PROGRAMS-PIL-v7.pdf |
| Target number of participants | Added 21/01/2009: 320 participants |
| Interventions |
1. Once daily granulocyte-macrophage colony-stimulating factor (GM-CSF) 10 µg/kg by subcutaneous injection, commenced within 72 hours of birth and continued for 5 days
2. No GM-CSF therapy Contact details for clinical queries (added 05/01/2010): Professor Neena Modi Professor of Neonatal Medicine Imperial College London 4th Floor Chelsea & Westminster Hospital 369 Fulham Road London, SW10 9NH United Kingdom T: +44 (0)20 8237 5102 E: n.modi@imperial.ac.uk |
| Primary outcome measure(s) |
1. Sepsis-free survival at 14 days from trial entry
2. Economic evaluation outcome: incremental cost-effectiveness analysis |
| Secondary outcome measure(s) |
Added 21/01/2009:
1. Survival without moderate/severe disability at 2 years from term 2. Survival to discharge 3. Sepsis: 3.1. Culture positive systemic infection, to 14 days from trial entry 3.2. Culture negative systemic infection, to 14 days from trial entry 3.3. Probable (culture positive or negative) systemic infection, to 28 days from trial entry 4. Clinical morbidity: 4.1. Chronic lung disease (bronchopulmonary dysplasia) 4.2. Necrotising enterocolitis, periventricular haemorrhage 4.3. Periventricular leucomalacia and ventriculomegaly 5. Haematological: 5.1. Culture positive systemic infection associated with neutropenia, to 14 days from trial entry 5.2. Culture positive systemic infection associated with neutropenia, to 28 days from trial entry |
| Sources of funding |
1. Action Medical Research (UK)
2. The Wellcome Trust (UK) (added 05/01/2010) (grant ref: 068499) |
| Trial website | http://www.npeu.ox.ac.uk/programs |
| Publications | 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19150703 |
| Contact name | Dr Neena Modi |
| Address |
Senior Lecturer/Consultant in Neonatal Paediatrics
Department of Paediatrics Hammersmith Hospital Du Cane Road |
| City/town | London |
| Zip/Postcode | W12 0NN |
| Country | United Kingdom |
| Tel | +44 (0)20 8383 3275 |
| n.modi@ic.ac.uk | |
| Sponsor | Imperial College London (UK) |
| Address |
Research Services, Medicine
Research Services Division Faculty Building South Kensington Campus South Kensington |
| City/town | London |
| Zip/Postcode | SW7 2AZ |
| Country | United Kingdom |
| Sponsor website: | http://www3.imperial.ac.uk/ |
| Date applied | 01/03/2001 |
| Last edited | 12/01/2010 |
| Date ISRCTN assigned | 01/03/2001 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
