Prophylactic granulocyte-macrophage colony-stimulating factor (GM-CSF) to reduce sepsis in preterm neonates

ISRCTN	ISRCTN42553489
DOI	https://doi.org/10.1186/ISRCTN42553489
Protocol serial number	SP3558
Sponsor	Imperial College London (UK)
Funders	Action Medical Research (UK), The Wellcome Trust (UK) (added 05/01/2010) (grant ref: 068499)

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

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
Email	n.modi@ic.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Primary outcome measure(s)	1. Sepsis-free survival at 14 days from trial entry 2. Economic evaluation outcome: incremental cost-effectiveness analysis
Key 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
Completion date	01/09/2005

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	320
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

United Kingdom
England

Study participating centre

Hammersmith Hospital

London
W12 0NN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes