Study designs of evaluations included in the review
Peer-reviewed, prospective randomised trials including a concurrent control group receiving either placebo or no IVIG treatment were eligible for inclusion. IVIG administration had to be given shortly after birth for prophylaxis, or on clinical diagnosis of sepsis for treatment.
Specific interventions included in the review
IVIG given either prophylactically to prevent neonatal sepsis or therapeutically to treat documented neonatal sepsis.
Participants included in the review
Newborns who were given IVIG prophylactically or as a treatment for sepsis. All studies included preterm low birth weight infants. The median upper age limits ranged between 23-34 weeks and median upper weight limits around 1500g. Excluded were infants with severe congenital malformation, intrauterine infection, hemolytic disease, metabolic disease and infants who died within 24 to 72 hours of birth or who were suspected or proven to be infected at the time prophylactic IVIG was given.
Outcomes assessed in the review
Prevention of neonatal sepsis was analysed on the basis of the outcome of a positive blood culture associated with clinical signs of systemic infection. Treatment of early onset neonatal sepsis was analysed on the basis of case fatality associated with sepsis.
How were decisions on the relevance of primary studies made?
The authors do not state how the papers were selected for the review, or how many of the authors performed the selection.