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Meta-Analysis
. 2020 Jan 29;1(1):CD000361.
doi: 10.1002/14651858.CD000361.pub4.

Intravenous immunoglobulin for preventing infection in preterm and/or low birth weight infants

Arne Ohlsson  1 , Janet B Lacy  2
Affiliations
Meta-Analysis

Intravenous immunoglobulin for preventing infection in preterm and/or low birth weight infants

Arne Ohlsson et al. Cochrane Database Syst Rev. .

Abstract

Background: Nosocomial infections continue to be a significant cause of morbidity and mortality among preterm and/or low birth weight (LBW) infants. Preterm infants are deficient in immunoglobulin G (IgG); therefore, administration of intravenous immunoglobulin (IVIG) may have the potential of preventing or altering the course of nosocomial infections.

Objectives: To use systematic review/meta-analytical techniques to determine whether IVIG administration (compared with placebo or no intervention) to preterm (< 37 weeks' postmenstrual age (PMA) at birth) or LBW (< 2500 g birth weight) infants or both is effective/safe in preventing nosocomial infection.

Search methods: For this update, MEDLINE, EMBASE, CINAHL, The Cochrane Library, Controlled Trials, ClinicalTrials.gov and PAS Abstracts2view were searched in May 2013.

Selection criteria: We selected randomised controlled trials (RCTs) in which a group of participants to whom IVIG was given was compared with a control group that received a placebo or no intervention for 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 5000 preterm and/or LBW infants met inclusion criteria. No new trials were identified in May 2013. When all studies were combined, a significant reduction in sepsis was noted (typical risk ratio (RR) 0.85, 95% confidence interval (CI) 0.74 to 0.98; typical risk difference (RD) -0.03, 95% CI 0.00 to -0.05; number needed to treat for an additional beneficial outcome (NNTB) 33, 95% CI 20 to infinity), and moderate between-study heterogeneity was reported (I2 54% for RR, 55% for RD). A significant reduction of one or more episodes was found for any serious infection when all studies were combined (typical RR 0.82, 95% CI 0.74 to 0.92; typical RD -0.04, 95% CI -0.02 to -0.06; NNTB 25, 95% CI 17 to 50), and moderate between-study heterogeneity was observed (I2 50% for RR, 62% for RD). No statistically significant differences in mortality from all causes were noted (typical RR 0.89, 95% CI 0.75 to 1.05; typical RD -0.01, 95% CI -0.03 to 0.01), and no heterogeneity for RR (I2 = 21%) or low heterogeneity for RD was documented (I2 = 28%). No statistically significant difference was seen in mortality from infection; in incidence of necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) or intraventricular haemorrhage (IVH) or in length of hospital stay. No major adverse effects of IVIG were reported in any of these 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 conducting additional RCTs to test the efficacy of previously studied IVIG preparations in reducing nosocomial infections in preterm and/or LBW infants.

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Conflict of interest statement

None

Figures

1
1
Forest plot of comparison: 1 IVIG versus placebo or no treatment, outcome: 1.1 Sepsis, one or more episodes.
2
2
Forest plot of comparison: 1 IVIG versus placebo or no treatment, outcome: 1.2 Any serious infection, one or more episodes.
3
3
Forest plot of comparison: 1 IVIG versus placebo or no treatment, outcome: 1.4 Mortality (all causes).
1.1
1.1. Analysis
Comparison 1 IVIG vs placebo or no treatment, Outcome 1 Sepsis, one or more episodes.
1.2
1.2. Analysis
Comparison 1 IVIG vs placebo or no treatment, Outcome 2 Any serious infection, one or more episodes.
1.3
1.3. Analysis
Comparison 1 IVIG vs placebo or no treatment, Outcome 3 NEC, one or more episodes.
1.4
1.4. Analysis
Comparison 1 IVIG vs placebo or no treatment, Outcome 4 Mortality (all causes).
1.5
1.5. Analysis
Comparison 1 IVIG vs placebo or no treatment, Outcome 5 Mortality (infectious).
1.6
1.6. Analysis
Comparison 1 IVIG vs placebo or no treatment, Outcome 6 Duration of hospitalisation.
1.7
1.7. Analysis
Comparison 1 IVIG vs placebo or no treatment, Outcome 7 Bronchopulmonary dysplasia.
1.8
1.8. Analysis
Comparison 1 IVIG vs placebo or no treatment, Outcome 8 Intraventricular haemorrhage any grade.
1.9
1.9. Analysis
Comparison 1 IVIG vs placebo or no treatment, Outcome 9 Intraventricular haemorrhage grade 3 or 4.
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References to other published versions of this review

Ohlsson 1998
    1. Ohlsson A, Lacy JB. Intravenous immunoglobulin for preventing infection in preterm and/or low birth weight infants. Cochrane Database of Systematic Reviews 1998, Issue 2. [DOI: 10.1002/14651858.CD000361] - DOI - PubMed
Ohlsson 2001
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