Prophylactic granulocyte-macrophage colony-stimulating factor (GM-CSF) to reduce sepsis in preterm neonates
| ISRCTN | ISRCTN42553489 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42553489 |
| Secondary identifying numbers | SP3558 |
- Submission date
- 01/03/2001
- Registration date
- 01/03/2001
- Last edited
- 30/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Neena Modi
Scientific
Scientific
Senior Lecturer/Consultant in Neonatal Paediatrics
Department of Paediatrics
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 (0)20 8383 3275 |
|---|---|
| n.modi@ic.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at http://www.npeu.ox.ac.uk/downloads/programs/PROGRAMS-PIL-v7.pdf |
| Scientific title | Prophylactic granulocyte-macrophage colony-stimulating factor (GM-CSF) to reduce sepsis in preterm neonates: a randomised controlled trial |
| Study acronym | PROGRAMS |
| Study objectives | 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. |
| Ethics approval(s) | NHS Executive South East MREC, 27/01/2000, ref: 99/85 |
| Health condition(s) or problem(s) studied | Sepsis |
| Intervention | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Granulocyte-macrophage colony-stimulating factor (GM-CSF) |
| Primary outcome measure | 1. Sepsis-free survival at 14 days from trial entry 2. Economic evaluation outcome: incremental cost-effectiveness analysis |
| Secondary outcome measures | 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 |
| Overall study start date | 01/09/2001 |
| Completion date | 01/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Added 21/01/2009: 320 participants |
| Key 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. |
| Key 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) |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 01/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hammersmith Hospital
London
W12 0NN
United Kingdom
W12 0NN
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
Research Services, Medicine
Research Services Division
Faculty Building
South Kensington Campus
South Kensington
London
SW7 2AZ
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- Location
- United Kingdom
The Wellcome Trust (UK) (added 05/01/2010) (grant ref: 068499)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/01/2009 | Yes | No | |
| Results article | results | 01/07/2015 | Yes | No |
