Sepsis Infections and Infestations Sepsis
Conditions
Interventions
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
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sepsis-free survival at 14 days from trial entry 2. Economic evaluation outcome: incremental cost-effectiveness analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed