Oral immunoglobulin for the treatment of rotavirus diarrhoea in low

Mohan P, Haque K

Background - Methods - Results - References


 

Dates

Date edited: 11/07/2007
Date of last substantive update: 17/04/2002
Date of last minor update: 30/04/2007
Date next stage expected 30/04/2009
Protocol first published: Issue 3, 2002
Review first published: Issue 1, 2003

Contact reviewer

Dr. Pammi Mohan, MD, DCh, MRCPCH
Assistant Professor
Pediatrics, Section of Neonataology
Baylor College of Medicine
6621, Fannin, MC.WT 6-104
Houston
Texas USA
77030
Telephone 1: 001 832 826 1380
Telephone 2: 001-713-795-9230
Facsimile: 001 832 825 2799
E-mail: mohanv@bcm.tmc.edu
Secondary address (home):
2250, Holly Hall street
Apt # 126
Houston
Texas USA
77054
Telephone: 001-713-795-9230

Contribution of reviewers

Pammi Mohan
Literature search and identification of trails for inclusion
Contacting prominent authors in the field for more data and unpublished trials
Abstraction of data from eligible studies
Evaluation of methodological quality of included trials
Verifying and entering data in RevMan
Writing the text of the review

Khalid Haque
Abstraction of data from eligible studies
Evaluation of methodological quality of included trials
Writing the text of the review

Internal sources of support

National Perinatal Epidemiology Unit, Headington, Oxford, UK
Epsom & St Helier NHS Trust, UK

External sources of support

None

What's new

This review is an update of the existing review "Oral immunoglobulin for the treatment of rotavirus diarrhoea in low birth weight infants", published in The Cochrane Library, Issue 1, 2003 (Mohan 2003).

There were no new trials identified by our updated search in April 2007. One study (Ventura 1993) awaiting assessment has been excluded. Abstract, background and Discussion sections have been updated. Five new references have been added to the additional references section.

Dates

Date review re-formatted: / /
Date new studies sought but none found: 30/04/2007
Date new studies found but not yet included/excluded: / /
Date new studies found and included/excluded: / /
Date reviewers' conclusions section amended: / /
Date comment/criticism added: / /
Date response to comment/criticisms added: / /

Text of review

Synopsis


Rotavirus infection can cause significant problems including diarrhoea in the newborn. This is particularly true in babies weighing less than 2500 g (low birthweight infants). Rotavirus infection is becoming more common in newborn babies and can spread from one baby to another in the neonatal unit. Administration of antibodies against rotavirus to babies may be one of the methods to treat this infection and to prevent the spread of infection in the neonatal unit. In this review, we did not identify any trial that used antibodies to treat rotavirus infection. More research is needed to address these issues.

Abstract



Background


Rotavirus infection is the most common neonatal nosocomial viral infection. It is a major health problem worldwide. Epidemics with the newer P(6)G9 strains have been reported in neonatal units globally. These strains can cause severe symptoms in most infected infants. Infection control measures become necessary and the utilization 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 treating rotaviral infections, especially in low birth weight babies.

Objectives


To determine the effectiveness and safety of oral immunoglobulin preparations for the treatment of rotavirus diarrhoea in hospitalized low birthweight infants (birth weight less than 2500 g)

Search strategy


Electronic databases including The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2004), MEDLINE, EMBASE and CINAHL, Biological Abstracts (BIOSIS) were searched by the strategy outlined in the protocol. Science Citation Index search for all articles that referenced Barnes 1982 were searched. The proceedings of the Pediatric Academic Societies, which were published in the journal Pediatric Research from 1991 and 'Abstracts Online' were searched. 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 also reviewed. The above search was updated in April 2007.

Selection criteria


The criteria used to select studies for inclusion were:
1) Design: randomized or quasi-randomized controlled trials
2) Hospitalized low birthweight infants with rotavirus diarrhoea
3) Intervention: Oral immunoglobulin preparations 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, 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 & analysis


The two reviewers were to independently abstract data from eligible trials. No data were available for analysis.

Main results


No eligible randomized controlled trials were found.

Reviewers' conclusions


No randomized controlled trials that assessed the effectiveness or safety of oral immunoglobulin preparations for the treatment of rotavirus diarrhoea in hospitalized low birthweight infants were found. Clinical trials that address the issue of oral immunoglobulin treatment of rotavirus infection are needed.

Background


Group A rotavirus infection is a major cause of diarrhoeal morbidity in children. Globally, it is estimated that in children < 5 yrs of age, rotavirus causes 111 million episodes of gastroenteritis requiring only home care, 25 million clinic visits, two million hospitalizations and 440,000 deaths. 82% of deaths occurred in the poorest countries (Parashar 2003). It has been recognized as the most common neonatal nosocomial viral infection (Strodtbeck 1986). Several outbreaks of rotaviral infection in neonatal nurseries in different countries have been reported (Bryden 1982; Shif 1983; Omoigberale 1995; Akinci 1991).

Rotavirus infection epidemics appear to be seasonal, being more common in the colder winter months. Infection rates range from 13% to 78% of neonates in the neonatal unit during epidemics (Widdowson 2000; Tufvesson 1986; Kilgore 1996; Cicirello 1994). The main reservoir of rotavirus infection in neonatal nurseries seems to be the infected neonate (Grillner 1985) and most infection occurs in the first few days of life (Kilgore 1996; Cicirello 1994). Cohorting healthy newborns in nurseries is no longer standard practice and hence this is not a problem in term newborns. However, survival rates have improved over the last decade for very low birth weight and extremely premature infants who stay longer in neonatal units. Premature and low birthweight infants and infants staying in the neonatal unit longer have shown to have a greater risk of acquiring rotavirus infection (Dennehy 1985; Walther 1984; Dearlove 1983). Rotavirus, especially the newer strains, can cause severe diarrhoea and dehydration in already sick neonates. Rotavirus infection has been shown to be associated with necrotizing enterocolitis (NEC) in premature infants during an outbreak in a neonatal unit (Mogilner 1983). In another study, 29% of neonates with NEC were stool rotavirus positive. Although these infants had lower Bell's Staging of NEC, the outcome of these infants regarding mortality or complication rates did not differ from rotavirus negative infants who had NEC (Sharma 2004). A significantly higher incidence of bradycardia-apnoea episodes (BAE) has been noticed two days before and two days after the diagnosis of rotavirus infection in infants. These episodes were followed by cyanosis and required intervention more often than did BAE episodes in rotavirus negative infants (Riedel 1996). Rotavirus infected neonates stay in the hospital longer than non-infected neonates, causing increased stress to the family and increased cost to the neonatal unit (Strodtbeck 1986). Strict infection control measures have been advocated including hand protection, hand disinfection, individual nursing sets, and cohorting infected babies (Grehn 1990). Closure of neonatal units (Valmari 1984) has been recommended to control and eradicate outbreaks of nosocomial rotavirus infections, placing considerable stress on busy neonatal units.

Newer strains of rotavirus P(6)G9 genotypes that previously have not been known to cause outbreaks of diarrhoea have been identified to cause epidemics in the UK (Cubitt 2000), US (Ramachandran 1999), Bangladesh (Unicomb 1999) and Europe (Widdowson 2000; Widdowson 2002). Unlike previous strains, the new P(6)G9 strains can cause serious outbreaks of diarrhoea in neonatal units and cause severe symptoms in most infected neonates. Most mothers have not been exposed to these new strains and thus a high proportion of neonates lack protective antibodies, which could explain high attack rates in the neonatal unit and the severity of symptoms. Predominance of neonatal cases compared to few cases in older children may indicate that neonates have an increased risk of infection by P(6)G9 strains.

Determinants of protective immunity against rotavirus are unclear but it has been suggested (Molyneaux 1995) that local mucosal immunity in the intestine may protect against rotavirus illness. While local antibodies may be important in the resolution of infection and protection from subsequent infections, there is no specific antibody that could be used reliably as a marker of protection (Ward 1996). Breast-fed infants are less susceptible to rotavirus infection, probably due to the presence of anti-rotaviral secretory IgA and trypsin inhibitors in the breast milk (McLean 1981; Jayashree 1988). The protective efficacy of breast milk correlates positively with the concentrations of anti-rotaviral secretory IgA in the breast milk (Jayashree 1988). Breast-fed infants tend to excrete fewer viruses than bottle-fed infants after infection with rotavirus (Chrystie 1978).

Oral administration of immunoglobulin containing preparations of bovine colostrum from immunized cows, egg yolk immunoglobulin from immunized hens (Mine 2002) or pooled plasma derived immunoglobulins can provide passive immunity. The highest titers of neutralizing anti-rotaviral antibodies are in bovine colostrum, then in egg yolk followed by human pooled plasma derived immunoglobulin (Bogstedt 1996). These preparations may inhibit intestinal viral adherence or viral replication and may have a role in the treatment of rotavirus infections. Oral immunoglobulin preparations are resistant to proteolytic digestion and retain significant neutralizing activity in the stools of treated infants .The newborn infant's immaturity of proteolytic enzymes or rapid gastro-intestinal transit time permits intact or nearly intact IgG to pass throughout the gastrointestinal system (Hilpert 1987; Blum 1981). In a prospective randomised placebo controlled study of oral human serum immunoglobulin in children (but not neonates) with acute rotaviral gastroenteritis, there was a reduction in total duration of viral diarrhoea, and viral excretion, and a faster clinical improvement compared to controls (Guarino 1994). Bovine colostrum from hyperimmunized pregnant cows has been shown to reduce viral excretion, stool output and the need for rehydration when used in the treatment of acute rotaviral gastroenteritis in children other than neonates (Hilpert 1987; Sarker 1998; Mitra 1995). It has also been shown to prevent diarrhoea from rotavirus infection when used as prophylaxis (Ebina 1996; Turner 1993). Antibodies derived from the yolk of rotavirus immunized hens have been tested in acute rotaviral gastroenteritis in children beyond the neonatal period in a randomized placebo controlled trial, and found to cause earlier clearance of virus from the stools and an improvement of diarrhoea (Sarker 1998). Advantages of administering oral immunoglobulin-containing preparations in neonates, especially low birthweight infants, would be a reduction in morbidity, reduction in the need for rehydration, earlier clearance of the virus thereby reducing the duration of infection control measures, and a reduction in hospital stay. Infection control measures are expensive and sometimes involve closure of infected units; oral immunoglobulins could be a cheaper and an easier alternative.

Rotavirus diarrhoea has the potential to resurface as a major problem in low birthweight infants especially with the newer strains. A systematic review of the efficacy and safety of oral immunoglobulin therapy in low birth weight infants for the treatment of rotavirus diarrhoea, according to Cochrane methodology is appropriate.

Objectives


1. To determine the effectiveness and safety of oral immunoglobulin preparations for the treatment of rotavirus diarrhoea in hospitalized low birthweight (birthweight < 2500 g) infants.

Criteria for considering studies for this review



Types of studies


Studies in which hospitalized low birth weight infants with rotavirus diarrhoea were randomized or quasi-randomized to receive oral immunoglobulin preparations OR either a placebo or no intervention.

Types of participants


Hospitalized low birthweight infants (birth weight < 2500 g) with rotavirus diarrhoea

Types of interventions


Oral immunoglobulin preparations, namely a) pooled plasma, b) colostrum from rotavirus immunized cows or c) egg yolk immunoglobulin from rotavirus immunized hens, used for treatment of rotavirus diarrhoea at any dose or duration.

Types of outcome measures



Primary outcome measures
:

Secondary outcome measures:

Definitions:



Search strategy for identification of studies


See: Collaborative Review Group search strategy
The search strategy used to identify studies was devised according to the guidelines of the Cochrane Neonatal Review Group. The following search strategy was updated in April 2007.

Relevant trials in any language were identified through
1. The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2007).
2. Electronic journal reference databases-
MEDLINE (1966-present) and PREMEDLINE
EMBASE (1980-present)
CINAHL (1982-present)
Biological Abstracts (BIOSIS)(1980-present)

3. Science citation index search for all articles, which quoted Barnes 1982 was performed.
4. Abstracts of conferences - proceedings of the Pediatric Academic Societies (American Pediatric Society, Society for Pediatric Research and the European Society for Paediatric Research). The reference lists of identified trials and abstracts published in Pediatric Research (1991-1999) and 'Abstracts Online' (2000-2006) were searched in MEDLINE and EMBASE for full published articles.
5. Communication was made with published authors for more information if necessary and other prominent authors in the field for possible unpublished studies whether or not they were presented as abstracts.
6. Additional searches were made in reference lists of identified clinical trials and in the reviewer's personal files.

MEDLINE, PREMEDLINE, EMBASE, CINAHL, Biological Abstracts search strategy
#1 Search Rotavirus
#2 Search Infant, newborn
#3 Search Infant, newborn, diseases
#4 Search neonat*
#5 Search Infant, low birth weight
#6 Search Infant, Very Low birth weight
#7 #2 OR #3 OR #4 OR #5 OR #6
#8 Search Immunoglobulin AND Oral
#9 Search Antibodies AND Oral
#10 Search Gammaglobulin AND Oral
#11 #8 OR #9 OR #10
#12 #1 AND #7 AND #11
#13 Limit #12 to (TG = Human) and (PG = Clinical trial)

No language restriction was applied. The reviewers erred on the side of over inclusion and later the articles, which did not meet the eligibility criteria were excluded.

Methods of the review


The titles and the abstracts of studies identified by the search strategy were assessed by the two authors independently. Differences were resolved by mutual discussion. Full text version of all eligible studies was to be obtained for quality assessment. Data extraction was to be done independently by the authors using paper proforma, and compared for differences, which were to be resolved by discussion.

We did not have data to perform the intended subgroup analyses. However as more research is done we believe that subgroup analyses listed below could be performed in the updates of this review:

1) Birthweight
Birthweight < 1500 grams
Birthweight from 1500 to 2500 grams

2) Type of oral immunoglobulin preparations
Oral immunoglobulin derived from pooled plasma
Oral immunoglobulin from the colostrum of rotavirus immunized cows
Oral immunoglobulins from egg yolk of rotavirus immunized hens

3) Type of rotavirus strains
Newer G(9) strains
Non G(9) strains

Assessment of the Quality of studies

The standardized review methods of the Cochrane Neonatal Review Group (CNRG) were to be used to assess the methodological quality of the studies. An assessment of the quality of the included studies was to be done by the two reviewers independently using the criteria developed by the CNRG.
Blinding of randomization (concealment of allocation)?
Blinding of intervention?
Blinding of outcome measure assessment?
Completeness of follow-up?
There are three potential answers to these questions - yes, can't tell, no.

ANALYSIS

Statistical analyses will be performed according to the recommendations of the CNRG in subsequent updates when data become available. Trials will be stratified by quality criteria. Planned analyses of the subgroups defined under the methods of the review and meta-analysis were not possible because of lack of eligible trials.

Description of studies


Three studies were identified by our search strategy that could potentially be eligible to be included in the review: Lodinova 1984; Ventura 1993; Barnes 1982.
All three studies were excluded.

Lodinova 1984
The first author confirmed that this study appeared as three reports (see References to studies, excluded studies). Fifty-six infants (preterm and term) admitted with diarrhoea were administered colostrum from cows immunised against 6 serotypes of E.Coli. They were compared with 29 infants (preterm and term) admitted with diarrhoea who were administered the standard treatment (no intervention). Outcomes reported were i) cure of diarrhoea (not defined) ii) need for oral antibiotics iii) need for parenteral rehydration iv) weight gain v) number of stools vi) quality of stools vii) bacterial pathogens before and after treatment viii) need for parenteral antibiotics ix) additional illnesses. This study was excluded because it was not a randomized study and rotavirus diarrhoea was not an eligibility criterion for this study.

Barnes 1982
The participants in this study were 75 infants with birthweights ranging from 2000 - 2500 grams, who were admitted to the special care baby unit, where rotavirus infection was known to be endemic. Rotavirus infection was not an eligibility criterion nor was diarrhoea. Seventy-five infants were randomized to receive either oral gammaglobulin or placebo within 12 hours of birth. A subset of 25 infants who excreted rotavirus sometime in the first two weeks of life were analyzed in the study report for the following outcomes: timing of excretion of rotavirus, grading of severity of rotavirus excretion, duration of excretion of rotavirus and the incidence of clinically important diarrhoea requiring low lactose feeds. Fifty out of 75 infants who did not excrete rotavirus were excluded from the analysis in the study report. This study was excluded because rotavirus diarrhoea in the participants was not an entry criterion.

Ventura 1993
Fifty-four infants (aged 1-36 months) admitted with acute diarrhoea were randomized to oral gammaglobulin (24 infants) or placebo (30 infants). Outcomes reported were duration of diarrhoea and duration of excretion of rotavirus in the two groups. Age and birth weight details are not available and, therefore, the study was excluded.

No studies were found eligible for inclusion in this review at this point.

Methodological quality of included studies


No trials were eligible.

Results


No randomised controlled trials eligible for inclusion in this review were found.

Discussion


Rotavirus infection is a major global problem and affects infants in both the developing and the developed countries. It accounts for a significant amount of diarrhoeal morbidity and mortality in children less than five years of age (Parashar 2003). Newer strains of rotavirus [P(6)G9] cause significant morbidity in infected neonates especially low birth weight and or premature neonates. It has the potential to resurface as a major problem in low birth infants admitted to the neonatal units who are at risk of significant morbidity. Infection control measures become imperative in affected neonatal units and place a considerable burden on health resources. This could mean closure or restriction of available neonatal cots or services and more health costs. Therefore, effective treatment of rotavirus infected neonates with diarrhoea assumes great clinical importance, more so in developing countries.

Active immunization with rotavirus vaccines can be an effective strategy to prevent rotavirus infections. The initial vaccine licensed was a tetravalent rhesus-human reassortment vaccine (Rotashield). Vaccination with this vaccine was discontinued because of safety concerns, as there was an association with intussuception. Currently available vaccines RotaTeq and RIX4414 (Rotarix) have not been shown to be associated with intussception and have shown about 70% efficacy against any rotavirus disease and 90-100% efficacy in preventing severe rotavirus disease (Vesikari 2006). The American Academy of Pediatrics has currently recommended a licensed pentavalent human-bovine reassortment rotavirus vaccine (RotaTeq) for routine vaccination in infants, to be given orally for three doses at two, four and six months of age (AAP 2007). However, current rotavirus vaccines do not include the newer P(6)G9 rotavirus strains and immunizations start at two months of age. Hence vaccination would not be expected to prevent neonatal rotavirus infection in hospitalized low birthweight infants.

Newer preparations of oral anti-rotaviral immunoglobulins namely cow's colostrum and egg yolk immunoglobulins (Mine 2002), which have a high titer of anti-rotaviral immunoglobulins have become available and have already shown to be beneficial in older children. Further evaluation of these oral immunoglobulin preparations in the treatment of rotavirus diarrhoea in low birthweight and or premature infants is therefore indicated.

Reviewers' conclusions



Implications for practice


No randomized controlled trials, which assessed the effectiveness or safety of oral immunoglobulin preparations for the treatment of rotavirus diarrhoea in hospitalized low birthweight infants were found.

Implications for research


Rotavirus diarrhoea remains a major problem in the developing world and could resurface as a significant problem in the developed world. There has been an emergence of newer strains of rotavirus, which cause a more severe clinical disease in infected neonates. Availability of high titre anti-rotaviral immunoglobulin preparations should encourage researchers to undertake well designed, large RCTs to evaluate the effectiveness and safety of these preparations in rotavirus infected infants, especially in low birthweight or premature infants. Low birthweight and/or premature infants are likely to have a higher mortality and morbidity after infections with newer strains of rotavirus and it will be prudent to test in this category of infants. Trialists should also be encouraged to address the treatment of rotavirus diarrhoea in low birthweight infants cared for at home in the developing world, who are at significant risk of morbidity and even death. Randomized controlled trials for treatment of rotavirus infection should use rapid diagnosis (Lipson 2001) to ascertain rotavirus infection as an eligibility criterion, in order to avoid confusion with other gastro-intestinal infections in low birthweight infants. Such randomized controlled trials should assess effects on a combination of outcomes, which include mortality, morbidity and health resource utilisation. Key outcomes would be a reduction in morbidity in this high risk group of infants, as well as duration of viral excretion, which will determine the duration of expensive infection control measures. The design of these RCTs should also include cost-effectiveness evaluations.

Acknowledgements


We would like to acknowledge the help of:
1) Nicola Bexon, Information Services Manager, Institute of Health Sciences, Oxford, for developing search strategies of literature conducted in June 2002.
2) Charlotta Pisinger for translating an article from Czech to English.
3) Elena Telaro from the Italian Cochrane Centre for help with the translation of an article from Italian to English.

Potential conflict of interest


None

Characteristics of excluded studies

StudyReason for exclusion
Barnes 1982Rotavirus diarrhoea was not an eligibility criterion for participant inclusion
Lodinova 1984Not a randomised study.
Ventura 1993Age and birth weight details of the randomised infants are not available and hence the study was excluded.
3 reports of the same study.

References to studies

References to excluded studies

Barnes 1982 {published data only}

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.

Lodinova 1984 {published data only}

* Lodinova R, Korych B, Bartakova Z, Brana H. Prevention and treatment of gastrointestinal infections in infants by using immunobiologic methods. Zentralblatt fur Gynakologie 1984;106:782-6.

Lodinova-Zadnikova R, Korych B, Bartakova Z, Tlaskalova H. Clinical evaluation of results in the therapy of gastrointestinal diseases with colostrum antibodies in premature infants and infants. Ceskoslovenska Pediatrie 1987;42:129-33.

Lodinova-Zadnikova R, Korych B, Bartakova Z. Treatment of gastrointestinal infections in infants by oral administration of colostral antibodies. Nahrung 1987;31:465-7.

Ventura 1993 {published data only}

Ventura A, Nassimbeni G, Martelossi S, Bohm P, D'Agaro PL. Esperienze con le gammaglobuline per os nella terapia e prevenzione della diarrea infettiva [Experience with gamma globulins per os in the therapy and prevention of infectious diarrhea]. La Pediatria Medica e Chirurgica: Medical and Surgical Pediatrics 1993;15:343-6.

* indicates the primary reference for the study

Other references

Additional references

AAP 2007

American Academy of Pediatrics Committee on Infectious Diseases. Prevention of rotavirus disease: guidelines for use of rotavirus vaccine. Pediatrics 2007;119:171-82.

Akinci 1991

Akinci A, Tezic T, Gur I, Cetin H, Hatun S. Rotavirus diarrhoea in newborn infants. Turkish Journal of Pediatrics 1991;33:153-7.

Bern 1992

Bern C, Martines J, de Zoysa I, Glass RI. The magnitude of the global problem of diarrhoeal disease: a ten year update. Bulletin of the World Health Organization 1992;70:705-14.

Blum 1981

Blum PM, Phelps DL, Ank BJ, Krantman HJ, Stiehm ER. Survival of oral human immune serum globulin in the gastrointestinal tract of low birth weight infants. Pediatric Research 1981;15:1256-60.

Bogstedt 1996

Bogstedt AK, Johansen K, Hatta H, Kim M, Casswell T, Svensson L, Hammarstrom L. Passive immunity against diarrhoea. Acta Paediatrica 1996;85:125-8.

Bryden 1982

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.

Chrystie 1978

Chrystie IL, Totterdell BM, Banatvala JE. Asymptomatic endemic rotavirus infections in the newborn. Lancet 1978;1:1176-8.

Cicirello 1994

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.

Cubitt 2000

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.

Dearlove 1983

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.

Dennehy 1985

Dennehy PH, Peter G. Risk factors associated with nosocomial rotavirus infection. American Journal of Diseases of Children 1985;139:935-9.

Ebina 1996

Ebina T. Prophylaxis of rotavirus gastroenteritis using immunoglobulin. Archives of Virology Suppl 1996;12:217-23.

Grehn 1990

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.

Grillner 1985

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.

Guarino 1994

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.

Hilpert 1987

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.

Jayashree 1988

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.

Kilgore 1996

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.

Lipson 2001

Lipson SM, Svenssen L, Goodwin L, Porti D, Danzi S, Pergolizzi R. Evaluation of two current generation enzyme immunoassays and an improved isolation-based assay for the rapid detection and isolation of rotavirus from stool. Journal of Clinical Virology 2001;21:17-27.

McLean 1981

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.

Mine 2002

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.

Mitra 1995

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.

Mogilner 1983

Mogilner BM, Bar-Yochai A, Miskin A, Shif I, Aboudi Y. Necrotizing enterocolitis associated with rotavirus infection. Israel Journal of Medical Sciences 1983;19:894-6.

Molyneaux 1995

Molyneaux PJ. Human immunity to rotavirus. Journal of Medical Microbiology 1995;43:397-404.

Omoigberale 1995

Omoigberale AI, Abiodun PO. Nosocomial rotavirus infections in newborns. East African Medical Journal 1995;72:220-1.

Parashar 2003

Parashar UD, Humelman EG, Bresee JS, Miller MA, Glass RI. Global illness and deaths caused by rotavirus disease in children. Emerging Infectious Diseases 2003;9:565-72.

Ramachandran 1999

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;36:3223-29.

Riedel 1996

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.

Sarker 1998

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.

Sarker 2001

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.

Sharma 2004

Sharma R, Garrison RD, Tepas JJ 3rd, Mollitt DL, Pieper P, Hudak ML, Bradshaw JL, Stevens G, Premachandra BR. Rotavirus-associated necrotising enterocolitis: an insight into a potentially preventable disease. Journal of Pediatric Surgery 2004;39:453-7.

Shif 1983

Shif I, Aboudy A, Mogilner B, Bar-Yochai A, Miskin A. Rotavirus infection in a neonatal intensive care nursery. Israel Journal of Medical Sciences 1983;19:860-2.

Strodtbeck 1986

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

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.

Turner 1993

Turner RB, Kelsey DK. Passive immunization for prevention of rotavirus illness in healthy infants. Pediatric Infectious Disease Journal 1993;12:718-22.

Unicomb 1999

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.

Valmari 1984

Valmari P, Pontynen S, Sunila R. Rotavirus infection in a neonatal unit. Annals of Clinical Research 1984;16:167-70.

Vesikari 2006

Vesikari T, Giaquinto C, Huppertz HI. Clinical trials of rotavirus vaccines in Europe. Pediatric Infectious Disease Journal 2006;25(1 suppl):S42-7.

Walther 1984

Walther FJ, Bruggeman C, Daniels-Bosman MS. Rotavirus infections in high-risk neonates. Journal of Hospital Infection 1984;5:438-43.

Ward 1996

Ward RL. Mechanisms of protection against rotavirus in humans and mice. Journal of Infectious Diseases 1996;174:S51-8.

Widdowson 2000

Widdowson MA, van Doornum GJJ, van der Poel WH, de Boer AS, Mahdi U, Koopmans M. Emerging group-A rotavirus and a nosocomial outbreak of diarrhoea. Lancet 2000;356:1161-2.

Widdowson 2002

Widdowson MA, van Doornum GJ, van der Poel WH, de Boer AS, van de Heide R, 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.

Other published versions of this review

Mohan 2003

Mohan P, Haque K. Oral immunoglobulin for the treatment of rotavirus diarrhoea in low birth weight infants. In: Cochrane Database of Systematic Reviews, Issue 1, 2003.

Contact details for co-reviewers

Dr Khalid N Haque, FRCP(Lond, Edin, Ire), FRCPCH, FPAMS(Pak), MBA
Reader in Neonatal Medicine & Consultant Neonatologist
Epsom & St Helier NHS Trust
Division of Neonatology, Department of Child Health
Queen Mary's Hospital for Children
Wrythe Lane, Carshalton
Surrey UK
SM5 1AA
Telephone 1: +44 208-296-2134
Telephone 2: +44 1932-847-947
Facsimile: 44 208 644 6878
E-mail: KhalidNH99@yahoo.com

 

This review is published as a Cochrane review in The Cochrane Library, Issue 3, 2007 (see http://www.thecochranelibrary.com for information). Cochrane reviews are regularly updated as new evidence emerges and in response to feedback. The Cochrane Library should be consulted for the most recent version of the review.