Intravenous immunoglobulin for preventing infection in preterm and/or low birth weight infants
Abstract
Background
Nosocomial infections continue to be a significant cause of morbidity and mortality among preterm and/or low birth weight infants. Preterm infants are deficient in IgG and, therefore, administration of intravenous immunoglobulin (IVIG) may have the potential of preventing or altering the course of nosocomial infections.
Objectives
To assess the effectiveness/safety of IVIG administration to preterm and/or low birth weight infants in preventing nosocomial infections.
Search methods
For this update MEDLINE, EMBASE, CINAHL, and The Cochrane Library were searched in December 2009.
Selection criteria
We selected randomized controlled trials (RCTs) in which administration of IVIG was compared to a control group that received a placebo or no intervention in preterm (< 37 weeks gestational age) and/or LBW (<2500 g) infants. Studies that were primarily designed to assess the effect of IVIG on humoral immune markers were excluded as were studies in which the follow‐up period was one week or less).
Data collection and analysis
Data collection and analysis was performed in accordance with the methods of the Cochrane Neonatal Review Group.
Main results
Nineteen studies enrolling approximately 5,000 preterm and/or LBW infants met inclusion criteria.
When all studies were combined there was a statistically significant reduction in sepsis (typical RR 0.85, 95% CI 0.74, 0.98; typical RD ‐0.03, 95% CI 0.00, ‐0.05). There was statistically significant between‐study heterogeneity (I2 54%). A statistically significant reduction was found for any serious infection, one or more episodes, when all studies were combined (typical RR 0.82, 95% CI 0.74, 0.92; typical RD ‐0.04, 95% CI ‐0.02, ‐0.06). There was statistically significant between‐study heterogeneity (I2 50%). There were no statistically significant differences for mortality from all causes, mortality from infection, incidence of NEC, BPD and IVH or length of hospital stay. No major adverse effects of IVIG were reported in any of the studies.
Authors' conclusions
IVIG administration results in a 3% reduction in sepsis and a 4% reduction in one or more episodes of any serious infection but is not associated with reductions in other clinically important outcomes including mortality. Prophylactic use of IVIG is not associated with any short‐term serious side effects.
The decision to use prophylactic IVIG will depend on the costs and the values assigned to the clinical outcomes. There is no justification for further RCTs testing the efficacy of previously studied IVIG preparations to reduce nosocomial infections in preterm and/or LBW infants.
PICOs
Plain language summary
Intravenous immunoglobulin for preventing infection in preterm and/or low birth weight infants
Infants may acquire infections while in the womb or in the hospital after birth, especially if they require intensive care. Such infections may cause serious illness or death. Transport of immunoglobulins (substances in the blood that can fight infections) from the mother to the fetus mainly occurs after 32 weeks gestation and infants do not begin to produce immunoglobulins until several months after birth. Theoretically, the adverse effects of infections could be reduced by the preventive administration of intravenous immunoglobulin. To date, approximately 5,000 infants have been enrolled in studies to evaluate the effect of prophylactic use of intravenous immunoglobulins on neonatal outcomes. Intravenous administration of immunoglobulins results in a 3% reduction in blood born infections and a 4% reduction in any serious infection. Intravenous administration of immunoglobulins is not associated with reductions in other important neonatal outcomes or length of hospital stay. Most importantly, intravenous immunoglobulin administration does not have any important effect on mortality. Prophylactic use of IVIG is not associated with any short term serious side effects. From a clinical perspective, a 3 ‐ 4% reduction in nosocomial infections without a reduction in mortality or other important clinical outcomes is of marginal importance.
