None listed
Conditions
Brief summary
This trial will test if intravenous immunoglobulin (IVIG) reduces death and disability in up to 5000 babies with suspected serious infection in the UK, Europe, Argentina, Australia and New Zealand. Newborn babies are deficient in immunoglobulins (physiological deficiency), especially if they are premature. Babies with severe infection after birth carry a high risk of death or life-long disability, even with appropriate antibiotics. IVIG is concentrated from plasma carefully screened blood donors and is one of the safest blood products available. Earlier trials suggest IVIG may reduce death rates in newborn infants, but did not report disability rates in survivors. Participants, Trialists at the coordinating centre, and clinical professionals involved in the care of the child are blinded to the study treatment. Only the pharmacist and lead statistician are aware of the treatment allocation.
Interventions
Intravenous administration of immunoglobulin (Intragam P) (500mg (10ml) per kg).
Administered twice in total (treatment given over 4-6 hours and then repeated 48 hours later).
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 28 Days
Healthy volunteers
No
Inclusion criteria
Infants are eligible if: they are receiving antibiotics with clinical evidence of definite or highly probable sepsis, there is substantial uncertainty that IVIG is indicated, birth weight is less than 1500g OR already has positive blood or cerebro spinal fluid culture OR receiving artifical ventilation.
Exclusion criteria
IVIG already given or thought to be needed or contra-indicated.
Outcome results
None listed