title: Oral immunoglobulin for the prevention of rotavirus infection in low birth weight infants.
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.
  
  
  OBJECTIVE
  To determine the effectiveness and safety of oral immunoglobulin preparations for the prevention of rotavirus infection in hospitalized low birthweight infants (birthweight < 2500 g)
  
  
  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
  
  
  METHODS
  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.
  
  
  METHODS
  The two review authors independently abstracted data from the included trials.
  
  
  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.
  
  
  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.
authors.affiliation: Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA. mohanv@bcm.tmc.edu
authors.forename: Mohan
authors.initials: M
authors.lastname: Pammi
authors.forename: Khalid N
authors.initials: KN
authors.lastname: Haque
mesh_terms: D000284:Administration, Oral; D006801:Humans; D007116:Immunization, Passive / Q000379:methods; D007136:Immunoglobulins / Q000008:administration & dosage*; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D016032:Randomized Controlled Trials as Topic; D012400:Rotavirus Infections / Q000517:prevention & control* / Q000821:virology; D017201:Virus Shedding
chemical_list: D007136:Immunoglobulins
references.citation: J Infect Dis. 1996 Sep;174 Suppl 1:S51-8
references.pmid: 8752291
references.citation: J Pediatr Gastroenterol Nutr. 2001 Jan;32(1):19-25
references.pmid: 11176319
references.citation: Ann Clin Res. 1984;16(3):167-70
references.pmid: 6476780
references.citation: J Med Virol. 2000 May;61(1):150-4
references.pmid: 10745248
references.citation: Eur J Pediatr. 1996 Jan;155(1):36-40
references.pmid: 8750808
references.citation: Pediatr Infect Dis J. 1998 Dec;17(12):1149-54
references.pmid: 9877365
references.citation: J Pediatr Surg. 2004 Mar;39(3):453-7
references.pmid: 15017569
references.citation: Pediatr Res. 1981 Sep;15(9):1256-60
references.pmid: 7290776
references.citation: Acta Paediatr Scand. 1986 Mar;75(2):211-5
references.pmid: 3008493
references.citation: Emerg Infect Dis. 2003 May;9(5):565-72
references.pmid: 12737740
references.citation: Pediatr Infect Dis J. 1996 Aug;15(8):672-7
references.pmid: 8858670
references.citation: Arch Virol Suppl. 1996;12:217-23
references.pmid: 9015118
references.citation: Pediatr Infect Dis J. 1993 Sep;12(9):718-22
references.pmid: 8414797
references.citation: Isr J Med Sci. 1983 Oct;19(10):894-6
references.pmid: 6662673
references.citation: J Med Virol. 1988 Nov;26(3):333-8
references.pmid: 3204368
references.citation: Lancet. 1978 Jun 3;1(8075):1176-8
references.pmid: 77944
references.citation: Infect Control Hosp Epidemiol. 2002 Nov;23(11):665-70
references.pmid: 12452294
references.citation: Pediatrics. 2009 May;123(5):1412-20
references.pmid: 19332437
references.citation: J Infect. 1982 Jan;4(1):43-8
references.pmid: 6764499
references.citation: Cochrane Database Syst Rev. 2003;(3):CD003740
references.pmid: 12917985
references.citation: Pediatr Med Chir. 1993 Jul-Aug;15(4):343-6
references.pmid: 7505434
references.citation: Scand J Infect Dis. 1985;17(4):349-55
references.pmid: 3003889
references.citation: J Clin Microbiol. 1999 Jun;37(6):1885-91
references.pmid: 10325342
references.citation: East Afr Med J. 1995 Apr;72(4):220-1
references.pmid: 7621755
references.citation: J Clin Microbiol. 1998 Nov;36(11):3223-9
references.pmid: 9774569
references.citation: Pediatr Infect Dis J. 1994 Aug;13(8):720-4
references.pmid: 7970972
references.citation: J Perinat Med. 1990;18(5):369-74
references.pmid: 1963447
references.citation: Acta Paediatr. 1995 Sep;84(9):996-1001
references.pmid: 8652974
references.citation: Am J Dis Child. 1985 Sep;139(9):935-9
references.pmid: 4036928
references.citation: J Med Microbiol. 1995 Dec;43(6):397-404
references.pmid: 7473672
references.citation: Isr J Med Sci. 1983 Sep;19(9):860-2
references.pmid: 6643031
references.citation: J Clin Microbiol. 1981 Jan;13(1):22-9
references.pmid: 6257755
references.citation: Pediatr Infect Dis J. 2006 Jan;25(1 Suppl):S42-7
references.pmid: 16397428
references.citation: J Infect Dis. 1987 Jul;156(1):158-66
references.pmid: 3110303
references.citation: J Med Food. 2002 Fall;5(3):159-69
references.pmid: 12495588
references.citation: Lancet. 1982 Jun 19;1(8286):1371-3
references.pmid: 6177981
references.citation: Pediatrics. 1994 Jan;93(1):12-6
references.pmid: 8265305
references.citation: Turk J Pediatr. 1991 Jul-Sep;33(3):153-7
references.pmid: 1792693
references.citation: Lancet. 2000 Sep 30;356(9236):1161-2
references.pmid: 11030297
references.citation: Acta Paediatr. 1996 Feb;85(2):125-8
references.pmid: 8640033
references.citation: J Hosp Infect. 1984 Dec;5(4):438-43
references.pmid: 6085100
references.citation: Br Med J (Clin Res Ed). 1983 May 7;286(6376):1473-5
references.pmid: 6303488