Intravenous immunoglobulin for suspected or subsequently proven infection in neonates

Cochrane Review by Ohlsson A, Lacy JB

This record should be cited as: Ohlsson A, Lacy JB. Intravenous immunoglobulin for suspected or subsequently proven infection in neonates. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD001239. DOI: 10.1002/14651858.CD001239.pub2.

ABSTRACT

Title

Intravenous immunoglobulin for suspected or subsequently proven infection in neonates

Background

Congenital and nosocomial infections are important causes of neonatal morbidity and mortality. Maternal transport of immunoglobulins to the fetus mainly occurs after 32 weeks gestation and endogenous synthesis does not begin until several months after birth. Administration of intravenous immunoglobulin provides IgG that can bind to cell surface receptors, provide opsonic activity, activate complement, promote antibody dependent cytotoxicity, and improve neutrophilic chemo luminescence. Theoretically infectious morbidity and morbidity could be reduced by the administration of intravenous immunoglobulin.

Objectives

To assess the effect of intravenous immunoglobulin (IVIG) on mortality/morbidity caused by suspected infection in newborn infants. A secondary objective was to assess the effect of IVIG on mortality/morbidity in those neonates who entered into the studies with suspected infection and who later were confirmed as being infected.

Search strategy

For this update of the review MEDLINE, EMBASE and the Cochrane Library were searched in July 2007. The reference lists of identified RCTs, meta-analyses and personal files were searched. No language restrictions were applied. No new trials were identified.

Selection criteria

The criteria used to select studies for inclusion were:1) Design: randomized and quasi-randomized controlled trials2) Newborn infants (< 28 days old)3) Intervention: IVIG for treatment of suspected (and in some infants subsequently proved) bacterial/fungal infection compared to placebo or no intervention.4) At least one of the following outcomes was reported: mortality during initial hospital stay; length of hospital stay; side effects; psychomotor development/growth at follow up.

Data collection and analysis

Two review authors independently abstracted information for the outcomes of interest and one researcher (AO) checked for any discrepancies and pooled the results.Typical Relative Risk (RR) and Risk Difference (RD) with 95% confidence intervals (CI) using the fixed effects model are reported for dichotomous outcomes and weighted mean difference (WMD) for continuous data. NNT were to be calculated for outcomes that showed a statistically significant reduction in RD. The RD and the NNT were not calculated for the subset of patients, who entered the trials with suspected sepsis and who were subsequently proven to have sepsis; such estimates are meaningless as the clinician is unaware at the point of starting treatment, whether the infant will have proven sepsis or not. The I-squared (I2 ) statistic was used to examine statistical heterogeneity.

Main results

Nine studies are included in this review. The updated search identified no new studies. Five hundred fifty three neonates with suspected infection have been enrolled in RCTs to evaluate the effect of IVIG on neonatal outcomes. These studies were undertaken in seven countries.

Authors' conclusions

There is insufficient evidence to support the routine administration of IVIG preparations investigated to date to prevent mortality in infants with suspected or subsequently proved neonatal infection.

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