Condition category
Infections and Infestations
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
30/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.npeu.ox.ac.uk/programs

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

http://www3.imperial.ac.uk/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes