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. 2011 Nov 9;2011(11):CD003740.
doi: 10.1002/14651858.CD003740.pub2.

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

Affiliations

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

Mohan Pammi et al. Cochrane Database Syst Rev. .

Abstract

Background: Rotavirus is a common neonatal nosocomial viral infection and epidemics with the newer P(6)G9 strains have been reported. Local mucosal immunity in the intestine to rotavirus is important in the resolution of infection and protection against subsequent infections. 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 hospitalized low birthweight infants (birthweight < 2500 g)

Search methods: The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), MEDLINE, EMBASE, CINAHL, biological Abstracts (BIOSIS), Science Citation Index for articles citing Barnes 1982 and the proceedings of the Pediatric Academic Societies from 1991 onwards were searched in July 2011. Ongoing trials were also searched at clinicaltrials.gov and controlled-trials.com

Selection criteria: The criteria used to select studies for inclusion were: 1) design: randomized or quasi-randomized controlled trials; 2) participants: hospitalized 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 diarrhea, need for rehydration, duration of viral excretion, duration of infection control measures, length of hospital stay in days, recurrent diarrhea or chronic diarrhea.

Data collection and analysis: The two review authors independently abstracted data from the included trials.

Main results: One published study (Barnes 1982) was eligible for inclusion in this review. Barnes 1982 found no significant difference in the rates of rotavirus infection after oral gammaglobulin versus placebo in hospitalized low birthweight babies [RR 1.27 (95% CI 0.65 to 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 to 4 days) and the group who had placebo (mean 3 days, range 1 to 6 days). Barnes 1982 reported no adverse effects after administration of oral immunoglobulin preparations.

Authors' conclusions: Current evidence does not support the use of oral immunoglobulin preparations to prevent rotavirus infection in low birthweight infants. Researchers are encouraged to conduct well-designed neonatal trials using the newer preparations of anti-rotaviral immunoglobulins (colostrum, egg yolk immunoglobulins) and include cost effectiveness evaluations.

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Conflict of interest statement

None

Figures

1.1
1.1. Analysis
Comparison 1 Oral immunoglobulin versus placebo, Outcome 1 Rotavirus infection.

Update of

References

References to studies included in this review

Barnes 1982 {published and unpublished data}
    1. Barnes GL, Doyle LW, Hewson PH, Knoches AML, McLellan JA, Kitchen WH, Bishop RF. A randomised trial of oral gammaglobulin in low‐birth‐weight infants infected with rotavirus. Lancet 1982;1:1371‐3. - PubMed

References to studies excluded from this review

Tam JS (unpublished) {unpublished data only}
    1. Tam JS, Cheng AFB, Fok T, Leung D, Oppenheimer SJ. Passive prevention of rotavirus infection in neonates by oral administration of hyperimmune bovine colostrum containing antibodies to four human rotavirus serotypes.
Ventura 1993 {published data only}
    1. Ventura A, Nassimbeni G, Martelossi S, Bohm P, D'Agro PL. Experience with gamma globulins per os in the therapy and prevention of infectious diarrhea [Esperienze con le gammaglobuline per os nella terapia e prevenzione della diarrea infettiva]. La Pediatria Medica e Chirurgica: Medical and Surgical Pediatrics 1993;15:343‐6. - PubMed

Additional references

AAP 2009
    1. American Academy of Pediatrics Committee on Infectious Diseases. Prevention of rotavirus disease: updated guidelines for use of rotavirus vaccine. Pediatrics 2009;123:1412‐20. - PubMed
Akinci 1991
    1. Akinci A, Tezic T, Gur I, Cetin H, Hatun S. Rotavirus diarrhoea in newborn infants. Turkisk Journal of Pediatrics 1991;33:153‐7. - PubMed
Blum 1981
    1. Blum PM, Phelps DL, Ank BJ, Krantman HJ, Stiehm ER. Survival of oral human serum globulin in the gastrointestinal tract of low birth weight infants. Pediatric Research 1981;15:1256‐60. - PubMed
Bogstedt 1996
    1. Bogstedt AK, Johansen K, Hatta H, Kim M, Casswell T, Svensson L, Hammarstrom L. Passive immunity against diarrhoea. Acta Paediatrica 1996;85:125‐8. - PubMed
Bryden 1982
    1. Bryden AS, Thouless ME, Hall CJ, Flewett TH, Wharton BA, Mathew PM, Craig I. Rotavirus infections in a special‐care baby unit. Journal of Infection 1982;4:43‐8. - PubMed
Chrystie 1978
    1. Chrystie IL, Totterdell BM, Banatvala JE. Asymptomatic endemic rotavirus infections in the newborn. Lancet 1978;1:1176‐8. - PMC - PubMed
Cicirello 1994
    1. Cicirello HG, Das BK, Gupta A, Bhan MK, Gentsch JR, Kumar R, Glass RI. High prevalence of rotavirus infection among neonates born at hospitals in Delhi, India: predisposition of newborns for infection with unusual rotavirus. Pediatric Infectious Disease Journal 1994;13:720‐4. - PubMed
Cubitt 2000
    1. Cubitt WD, Steele AD, Iturriza M. Characterisation of rotaviruses from children treated at a London hospital during 1996: emergence of strains G9P2A[6] and G3P2A[6]. Journal of Medical Virology 2000;61:150‐4. - PubMed
Dearlove 1983
    1. Dearlove J, Latham P, Dearlove B, Pearl K, Thomson A, Lewis IG. Clinical range of neonatal rotavirus gastroenteritis. British Medical Journal 1983;286:1473‐5. - PMC - PubMed
Dennehy 1985
    1. Dennehy PH, Peter G. Risk factors associated with nosocomial rotavirus infection. American Journal of Diseases of Children 1985;139:935‐9. - PubMed
Ebina 1996
    1. Ebina T. Prophylaxis of rotavirus gastroenteritis using immunoglobulin. Archives of Virology Suppl 1996;12:217‐23. - PubMed
Grehn 1990
    1. Grehn M, Kunz J, Sigg P, Slongo R, Zbinden R. Nosocomial rotavirus infections in neonates: means of prevention and control. Journal of Perinatal Medicine 1990;18:369‐74. - PubMed
Grillner 1985
    1. Grillner L, Broberger U, Chrystie I, Ransjo U. Rotavirus infections in newborns: an epidemiological and clinical study. Scandinavian Journal of Infectious Diseases 1985;17:349‐55. - PubMed
Guarino 1994
    1. Guarino A, Canani RB, Russo S, Albano F, Canani MB, Ruggeri FM, Donelli G, Rubino A. Oral immunoglobulins for treatment of acute rotaviral gastroenteritis. Pediatrics 1994;93:12‐6. - PubMed
Higgins 2011
    1. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
Hilpert 1987
    1. Hilpert H, Brussow H, Mietens C, Sidoti J, Lerner L, Werchau H. Use of bovine milk concentrate containing antibody to rotavirus to treat rotavirus gastroenteritis in infants. Journal of Infectious Diseases 1987;156:158‐66. - PubMed
Jayashree 1988
    1. Jayashree S, Bhan MK, Kumar R, Bhandari N, Sazawal S. Protection against neonatal rotavirus infection by breast milk antibodies and trypsin inhibitors. Journal of Medical Virology 1988;26:333‐8. - PubMed
Kilgore 1996
    1. Kilgore PE, Unicomb LE, Gentsch JR, Albert MJ, McElroy CA, Glass RI. Neonatal rotavirus infection in Bangladesh: strain characterization and risk factors for nosocomial infection. Pediatric Infectious Disease Journal 1996;15:672‐7. - PubMed
McLean 1981
    1. McLean BS, Holmes IH. Effects of antibodies, trypsin, and trypsin inhibitors on susceptibility of neonates to rotavirus infection. Journal of Clinical Microbiology 1981;13:22‐9. - PMC - PubMed
Mine 2002
    1. Mine Y, Kovacs‐Nolan J. Chicken egg yolk antibodies as therapeutics in enteric infectious disease: A review. Journal of Medicinal Food 2002;5:159‐69. - PubMed
Mitra 1995
    1. Mitra AK, Mahalanabis D, Ashraf H, Unicomb L, Eeckels R, Tzipori S. Hyperimmune cow colostrum reduces diarrhoea due to rotavirus: a double‐blind, controlled clinical trial. Acta Paediatrica 1995;84:996‐1001. - PubMed
Mogilner 1983
    1. Mogilner BM, Bar‐Yochai A, Miskin A, Shif I, Aboudi Y. Necrotizing enterocolitis associated with rotavirus infection. Israel Journal of Medical Science 1983;19:894‐6. - PubMed
Molyneaux 1995
    1. Molyneaux PJ. Human immunity to rotavirus. Journal of Medical Microbiology 1995;43:397‐404. - PubMed
Omoigberale 1995
    1. Omoigberale AI, Abiodun PO. Nosocomial rotavirus infection in newborns. East African Medical Journal 1995;72:220‐1. - PubMed
Parashar 2003
    1. Parashar UD, Hummelman EG, Bresee JS, Miller MA, Glass RI. Global illness and deaths caused by rotavirus disease in children. Emerging Infectious Diseases 2003;9:565‐72. - PMC - PubMed
Ramachandran 1998
    1. Ramachandran M, Gentsch JR, Parashar UD, Jin S, Woods PA, Holmes JL, Kirkwood CD, Bishop RF, Greenberg HB, Urasawa S, Gerna G, Coulson BS, Taniguchi K, Bresee JS, Glass RI. Detection and characterisation of novel rotavirus strains in the United States. Journal of Clinical Microbiology 1998;36:3223‐9. - PMC - PubMed
Riedel 1996
    1. Riedel F, Kroener T, Stein K, Nuesslein TG, Rieger CH. Rotavirus infection and bradycardia‐apnoea‐episodes in the neonate. European Journal of Pediatrics 1996;155:36‐40. - PubMed
Sarker 1998
    1. Sarker SA, Casswall TH, Mahalanabis D, Alam NH, Albert MJ, Brussow H, Fuchs GJ, Hammarstrom L. Successful treatment of rotavirus diarrhea in children with immunoglobulin from immunized bovine colostrum. Pediatric Infectious Disease Journal 1998;17:1149‐54. - PubMed
Sarker 2001
    1. Sarker SA, Casswall TH, Juneja LR, Hoq E, Hossain I, Fuchs GJ, Hammarstrom L. Randomized placebo‐controlled, clinical trial of hyperimmunized chicken egg yolk immunoglobulin in children with rotavirus diarrhea. Journal of Pediatric Gastroenterology and Nutrition 2001;32:19‐25. - PubMed
Sharma 2004
    1. Sharma R, Garrison RD, Tepas JJ 3rd, Mollitt DL, Pieper P, Hudak ML, Bradshaw JA, Stevens G, Premachandra BR. Rotavirus‐associated necrotizing enterocolitis: an insight into a potentially preventable disease. Journal of Pediatric Surgery 2004;39:453‐7. - PubMed
Shif 1983
    1. Shif I, Aboudy A, Mogilner B, Bar‐Yochai A, Miskin A. Rotavirus infection in a neonatal intensive care nursery. Israeal Journal of Medical Science 1983;19:860‐2. - PubMed
Strodtbeck 1986
    1. Strodtbeck F. The epidemiology of nosocomial viral infections in infants who are long term residents of the neonatal intensive care unit. Indiana University School of Nursing. Doctoral thesis 1986.
Tufvesson 1986
    1. Tufvesson B, Polberger S, Svanberg L, Sveger T. A prospective study of rotavirus infections in neonatal and maternity wards. Acta Paediatrica Scandinavica 1986;75:211‐5. - PubMed
Turner 1993
    1. Turner RB, Kelsey DK. Passive immunization for prevention of rotavirus illness in healthy infants. Pediatric Infectious Disease Journal 1993;12:718‐22. - PubMed
Unicomb 1999
    1. Unicomb LE, Podder G, Gentsch JR, Woods PA, Hasan KZ, Faruque AS, Albert MJ, Glass RI. Evidence of high frequency reassortment of Group A rotavirus strains in Bangladesh: emergence of type G9 in 1995. Journal of Clinical Microbiology 1999;37:1885‐91. - PMC - PubMed
Valmari 1984
    1. Valmari P, Pontynen S, Sunila R. Rotavirus infection in a neonatal unit. Annals of Clinical Research 1984;16:167‐70. - PubMed
Vesikari 2006
    1. Vesikari T, Giaquinto C, Huppertz HI. Clinical trials of rotavirus vaccines in Europe. Pediatric Infectious Disease Journal 2006;25(1 suppl):S42‐7. - PubMed
Walther 1984
    1. Walther FJ, Bruggeman C, Daniels‐Bosman MS. Rotavirus infections in high‐risk neonates. Journal of Hospital Infection 1984;5:438‐43. - PubMed
Ward 1996
    1. Ward RL. Mechanisms of protection against rotavirus in humans and mice. Journal of Infectious Diseases 1996;174:S51‐8. - PubMed
Widdowson 2000
    1. Widdowson MA, Doornum GJJ, Poel WH, Boer AS, Mahdi U, Koopmans M. Emerging group‐A rotavirus and a nosocomial outbreak of diarrhoea. Lancet 2000;356:1161‐2. - PubMed
Widdowson 2002
    1. Widdowson MA, Doornum GJ, Poel WH, Boer AS, HR, Mahdi U, Haanen P, Kool JL, Koopmans M. An outbreak of diarrhea in a neonatal medium care unit caused by a novel strain of rotavirus: investigation using both epidemiologic and microbiological methods. Infection Control and Hospital Epidemiology 2002;23:665‐70. - PubMed

References to other published versions of this review

Mohan 2002
    1. Pammi M, Haque K. Oral immunoglobulin for the prevention of rotavirus infection in low birth weight infants. Cochrane Database of Systematic Reviews 2002, Issue 3. [DOI: 10.1002/14651858.CD003740] - DOI - PubMed

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