Oral immunoglobulin for the prevention of rotavirus infection in low birth weight infants.

BACKGROUND Rotavirus infection is the most common neonatal nosocomial viral infection. Epidemics with the newer P(6)G9 strains have been reported in neonatal units worldwide. These strains can cause severe symptoms in infected infants. Infection control measures become necessary and the utilisation of hospital resources increase. Local mucosal immunity in the intestine to rotavirus is important in the resolution of infection and protection against subsequent infections. Boosting local immunity by oral administration of anti-rotaviral immunoglobulin preparations might be a useful strategy in preventing rotaviral infections, especially in low birth weight babies. OBJECTIVES To determine the effectiveness and safety of oral immunoglobulin preparations for the prevention of rotavirus infection in hospitalised low birthweight infants (birth weight less than 2500 gms) SEARCH STRATEGY The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2002), MEDLINE, EMBASE and CINAHL were searched. Science Citation Index was searched for all articles which referenced Barnes 1982. The proceedings of the Pediatric Academic Societies which were published in the journal, Pediatric Research from 1991 onwards were searched as well as abstracts of doctoral dissertations and theses from 1960 onwards. The above mentioned search strategy was completed in June 2002. Authors prominent in the field were contacted for any unpublished articles and more information on published articles was sought. Reference lists of identified clinical trials and personal files were reviewed. SELECTION CRITERIA The criteria used to select studies for inclusion were: 1) DESIGN: randomised or quasi-randomised controlled trials. 2) PARTICIPANTS: Hospitalised low birthweight infants. 3) INTERVENTION: Oral immunoglobulin preparations for prevention of rotavirus infection compared to placebo OR no intervention. 4) At least one of the following outcomes were reported: All cause mortality during hospital stay, mortality due to rotavirus infection during hospital stay, rotavirus infection, duration of diarrhoea, need for rehydration, duration of viral excretion, duration of infection control measures, length of hospital stay in days, recurrent diarrhoea or chronic diarrhoea. DATA COLLECTION AND ANALYSIS The two reviewers independently abstracted data from the included trials MAIN RESULTS One published study (Barnes 1982) was eligible for inclusion in this review. Two additional studies are awaiting assessment re eligibility for inclusion. Barnes 1982 found no significant difference in the rates of rotavirus infection after oral gammaglobulin versus placebo in hospitalised low birthweight babies [RR 1.27 (95% CI 0.65-2.37)]. In the subset of infants who became infected with rotavirus after receiving gammaglobulin or placebo for prevention of rotavirus infection, there was no significant difference in the duration of rotavirus excretion between the group who had gammaglobulin (mean 2 days, range 1-4 days) and the group who had placebo (mean 3 days, range 1-6 days). No adverse effects were reported by Barnes 1982 after administration of oral immunoglobulin preparations. REVIEWER'S CONCLUSIONS Current evidence from one randomised controlled trial does not support the routine use of oral immunoglobulin preparations for the prevention of rotavirus infection in low birth-weight infants. However, newer immunoglobulin preparations which have been found to be effective in older children have not been tested in neonatal trials. Therefore, researchers should be encouraged to conduct well designed trials in neonates at risk for rotavirus infections using the newer preparations of anti-rotaviral immunoglobulins (colostrum, egg yolk immunoglobulins). Such trials should also include cost effectiveness evaluations.