Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Neena Modi
ORCID ID
Contact details
Senior Lecturer/Consultant in Neonatal Paediatrics
Department of Paediatrics
Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom
+44 (0)20 8383 3275
n.modi@ic.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SP3558
Study information
Scientific title
Prophylactic granulocyte-macrophage colony-stimulating factor (GM-CSF) to reduce sepsis in preterm neonates: a randomised controlled trial
Acronym
PROGRAMS
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.
Ethics approval
NHS Executive South East MREC, 27/01/2000, ref: 99/85
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at http://www.npeu.ox.ac.uk/downloads/programs/PROGRAMS-PIL-v7.pdf
Condition
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
Phase
Not Applicable
Drug names
Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Primary outcome measures
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 trial start date
01/09/2001
Overall trial end date
01/09/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Added 21/01/2009: 320 participants
Participant 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)
Recruitment start date
01/09/2001
Recruitment end date
01/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hammersmith Hospital
London
W12 0NN
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
Research Services
Medicine
Research Services Division
Faculty Building
South Kensington Campus
South Kensington
London
SW7 2AZ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
The Wellcome Trust (UK) (added 05/01/2010) (grant ref: 068499)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19150703
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25922190
Publication citations
-
Results
Carr R, Brocklehurst P, Doré CJ, Modi N, 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., Lancet, 2009, 373, 9659, 226-233, doi: 10.1016/S0140-6736(09)60071-4.
-
Results
Marlow N, Morris T, Brocklehurst P, Carr R, Cowan F, Patel N, Petrou S, Redshaw M, Modi N, Doré CJ, A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: childhood outcomes at 5 years, Arch Dis Child Fetal Neonatal Ed, 2015, doi: 10.1136/archdischild-2014-307410.