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

Plain English Summary

Not provided at time of registration

Study website

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

Type

Scientific

Contact name

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

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

SP3558

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(s)

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

Study setting(s)

Hospital

Study 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

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

Overall study end date

01/09/2005

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Neonate

Sex

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

Countries of recruitment

England, United Kingdom

Study participating centre

Hammersmith Hospital
London
W12 0NN
United Kingdom

Organisation

Imperial College London (UK)

Sponsor details

Research Services
Medicine
Research Services Division
Faculty Building
South Kensington Campus
South Kensington
London
SW7 2AZ
England
United Kingdom

Sponsor type

University/education

Website

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

ROR

https://ror.org/041kmwe10

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

actionmedres, action medical research for children, AMR

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

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

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs