The INIS Study: Immunoglobulin Therapy for Neonatal Sepsis
Author Information
Author(s): Peter Brocklehurst, Sally Brearley, Khalid Haque, Andy Leslie, Alison Salt, Ben Stenson, Jim Stephenson, William Tarnow-Mordi
Primary Institution: National Perinatal Epidemiology Unit
Hypothesis
In infants receiving antibiotics for clinical sepsis, the addition of non-specific, polyclonal intravenous immunoglobulin IgG (IVIG) therapy reduces mortality and major morbidity compared with antibiotics alone.
Conclusion
The study aims to determine if intravenous immunoglobulin therapy can reduce mortality and adverse neuro-developmental outcomes in infants with neonatal sepsis.
Supporting Evidence
- Previous studies suggest that intravenous immunoglobulin may reduce mortality in neonatal sepsis.
- Existing trials indicate that IVIG therapy is associated with a significant reduction in mortality risk.
- Systematic reviews have shown that IVIG is safe and can reduce sepsis incidence.
Takeaway
This study is trying to find out if giving a special medicine called immunoglobulin can help sick newborns with infections live longer and healthier lives.
Methodology
A randomised, placebo controlled, double blind trial involving infants with suspected or proven neonatal sepsis.
Potential Biases
Potential biases include lack of allocation concealment and blinding of outcome assessment in previous studies.
Limitations
Existing trials were small and lacked long-term follow-up data.
Participant Demographics
Infants receiving antibiotics for suspected or proven serious infection, with specific eligibility criteria based on birth weight and clinical signs.
Digital Object Identifier (DOI)
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