Obstetrics and Gynaecology Infections and Infestations Sepsis
Conditions
Interventions
Intravenous infusion of IVIG (500 mg [10 ml]/kg) or matching placebo, repeated after 48 h.
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants who: 1. Are receiving antibiotics with clinical evidence of definite or highly probable sepsis 2. There is substantial uncertainty that IVIG is indicated 3. Birth weight is less than 1500 g OR already has positive blood or Cerebral Spinal Fluid (CSF) culture OR receiving artificial ventilation
Exclusion criteria
Exclusion criteria: IVIG already given or thought to be needed or contraindicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality or major disability at 2 years of age (corrected for gestational age at birth). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Short term: mortality, chronic lung disease or major cerebral abnormality before hospital discharge, significant positive culture after trial entry, pneumonia, necrotising enterocolitis, duration of respiratory support 2. Long term: mortality before two years, major disability at 2 years, non-major disability at 2 years. 3. Health service utilisation: length of hospital stay | — |
Countries
Argentina, Australia, Belgium, Denmark, Greece, Ireland, New Zealand, Serbia, United Kingdom
Outcome results
None listed