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Faeces from children under 2 years old who had gastroenteritis that could not be attributed to recognised enteric pathogens were examined with a monoclonal-antibody-based immunoassay for Pestivirus antigens. Such antigens were detected in 30 of 128 episodes of gastroenteritis. Children without diarrhoeal disease and children infected with rotaviruses had little evidence of Pestivirus infection (faeces positive in 1 of 28 and 1 of 31, respectively). The diarrhoeal disease in children excreting Pestivirus antigens resembled that in other children except that it was more commonly associated with signs and symptoms of respiratory inflammation. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The hospitalization rate for bronchiolitis of any cause among US children younger than 1 year is estimated at 31.2 per 1000. No data exist on respiratory syncytial virus (RSV)-specific hospitalization rates among high-risk Native Americans other than Alaska Natives, for whom the incidence of RSV hospitalization was estimated at 150 per 1000 among infants younger than 1 year. We aimed to estimate RSV hospitalization rates among Navajo and White Mountain Apache children younger than 2 years. METHODS: We conducted prospective population-level hospital-based surveillance to determine RSV hospitalization rates among Navajo and White Mountain Apache children younger than 2 years. From 1997 to 2000, all children who were admitted for acute lower respiratory tract infection between October 1 and March 31 had a nasopharyngeal aspirate obtained and tested for RSV by commercial enzyme immunoassay kits. We reviewed charts of children who tested positive for RSV antigen to determine disease severity. RESULTS: During 3 RSV seasons (1997-2000), 51.3% of 1837 admissions for acute lower respiratory tract infection among children younger than 2 years were attributed to RSV infection. The overall seasonal RSV hospitalization rate among children younger than 2 years was 63.6 per 1000 and 91.3 per 1000 among children younger than 1 year. In a univariate analysis, predictors of severity included age <6 months (relative risk: 6.8; 95% confidence interval: 3.1-17.0). CONCLUSIONS: Navajo and White Mountain Apache children are at high risk for RSV disease requiring hospitalization. A lower threshold for hospitalization or underlying chronic conditions that predispose to severe RSV disease do not seem to explain high RSV hospitalization rates in this population. [Abstract for this article also available on page 396 of printed version. Full article available at http://www.pediatrics.org/cgi/content/full/110/2/e20] [ABSTRACT FROM AUTHOR]

Background: Multi-locus sequence typing (MLST) of pneumococcal isolates collected during an efficacy trial of the 7-valent pneumococcal conjugate vaccine (PCV7) among Navajo and White Mountain Apache children from 1998 to 2000 showed a non-differential expansion of pre-existing sequence types (STs) and only one capsule-switching event in the PCV7-randomized communities. PCV7 was introduced as a routine infant vaccine in October 2000. We assessed variability in PCV7 effectiveness and mechanisms of ST replacement after prolonged routine PCV7 use., Methods: We applied MLST to 267 non-vaccine type pneumococcal carriage and invasive disease isolates from Navajo and White Mountain Apache children from 2006 to 2008, and compared them to those from 1998 to 2000. Microarray was used to confirm capsule switching events., Results: The primary mechanism of ST replacement among Navajo and White Mountain Apache children was expansion of existing STs, although introduction of new STs was an important secondary mechanism. ST199, a majority being serotype 19A, was the most common ST in both eras. Only ST193 (serotype 21) was preferentially expanding in the PCV7 era. Three examples of capsule switching were identified. No variability in vaccine effectiveness by ST was observed., Conclusion: We did not observe an influence of ST on PCV7 serotype-specific effectiveness, although some STs may be favored in replacement., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Background: Prior to the introduction of the 7-valent pneumococcal conjugate vaccine (PCV7), the rate of invasive pneumococcal disease (IPD) was 8-fold higher among White Mountain Apache persons of all ages than it was among the general US population, . We aimed to assess the impact of PCV7 and 23-valent pneumococcal polysaccharide vaccine on the rate of IPD among White Mountain Apache persons., Methods: From 1991 through 2006, we conducted active laboratory- and population-based surveillance among Native American residents of the White Mountain Apache reservation. Charts were reviewed and pneumococcal isolates were collected for serotype testing. Three time periods were defined: the pre-PCV7 baseline period (1991-1997), the PCV7 efficacy trial period (1998-2000), and the PCV7 routine-use period (2001-2006)., Results: We identified 246 cases of IPD; the mean annual IPD rate fell from 126 cases per 100,000 person-years in the period 1991-1997 to 87 cases per 100,000 person-years in the period 2001-2006 (p = .01). The rate of IPD attributable to PCV7 serotypes of Streptococcus pneumoniae decreased by 252 cases per 100,000 person-years (92%) among children aged <5 years, and that attributable to non-PCV7 serotypes of S. pneumoniae decreased by 87 cases per 100,000 person-years (44%) among children aged <5 years. Among adults, the rate of IPD remained unchanged; PCV7 serotypes of S. pneumoniae accounted for only 25% of adult cases during the period 1991-1997., Conclusions: Since the introduction of PCV7, the rate of IPD among White Mountain Apache children aged <5 years has decreased to the lowest rate ever (122 cases per 100,000 person-years), but it remains 5.7-fold greater than the rate of IPD among children in the general US population. In contrast to some other high-risk populations, there is no evidence of non-vaccine-type replacement disease in this age group. Among White Mountain Apache adults, the rate of IPD remains substantially higher than that observed in the general US population. Vaccines with broader serotype coverage are needed to further reduce the disparity in the rate of IPD between the White Mountain Apache and general US populations.

Background: Certain Native American populations have high rates of invasive pneumococcal disease (IPD). We aimed to determine the disease spectrum and risk factors of White Mountain Apache adults (age, >or=18 years) with IPD and the use and effectiveness of pneumococcal polysaccharide vaccine (PPV) in this population., Methods: We conducted active surveillance for IPD between 1991 and 2005. Medical records were reviewed, and isolates were serotyped. Vaccine use was assessed in 2004-2005 among White Mountain Apache adults with an indication for pneumococcal vaccination. The effectiveness of PPV was determined through an indirect cohort method., Results: Among the 115 IPD cases (in 109 persons), the mean age was 43 years; 62% were male; 91% had risk factors, and alcoholism predominated (73%). Alcoholic patients were younger (mean age, 40.1 years; P<.001) and more often male (70%; P=.001) compared with nonalcoholic patients. The case fatality rate was 15%; all deaths occurred among those with risk factors. Only age 65 years or older was associated with increased risk of death. Of 447 White Mountain Apache persons at high risk, 76% had received PPV. Vaccination rates were highest among subjects with pulmonary disease (95%) and diabetes (89%) and lowest among those aged 50 to 64 years (40%). Of the 115 IPD cases for which serotypes were available, 77% were due to serotypes contained in PPV. The effectiveness of PPV against serotype-specific IPD, as measured by the indirect cohort analysis of IPD cases, was 68% (95% confidence interval, 3%-90%)., Conclusions: Among White Mountain Apache adults with IPD, alcoholism is common and contributes to the younger age and male predominance of cases. Pneumococcal vaccination rates are high, and there is suggestive evidence of the effectiveness of PPV in this population. Additional preventive strategies, including risk factor modification and vaccination of younger high-risk adults, should be pursued.

Background: Before the introduction of Haemophilus influenzae type b (Hib) conjugate vaccines, rates of H. influenzae disease among Navajo and White Mountain Apache (WMA) children were among the highest reported worldwide. Routine Hib vaccination has significantly reduced rates of Hib disease in these populations. As Hib disease rates decrease to very low levels, there are concerns that non-type b strains of H. influenzae may emerge as more prevalent causes of invasive disease in children., Methods: We reviewed population-based, active laboratory surveillance data from the period of 1988-2003 for invasive H. influenzae type a (Hia) disease among Navajo and WMA children aged <5 years. Clinical information on cases was collected by chart review. A sample of Hia isolates from Navajo children was typed by pulsed-field gel electrophoresis (PFGE)., Results: During 1988-2003, a total of 76 reported cases of invasive Hia disease occurred among Navajo and WMA children. The overall annual incidence was 20.2 cases per 100,000 population aged <5 years. There was no increase in Hia disease rates after Hib vaccination was introduced. The median age of patients was 12 months. Meningitis (50% of cases) was the most common presentation, followed by pneumonia (27.6%). Two children with Hia disease died. PFGE analysis revealed a limited genetic diversity of Hia strains in this population., Conclusions: Active surveillance data showed high rates of invasive Hia disease among Navajo and WMA children but no increase in the incidence after Hib vaccination was introduced. The presentation of Hia disease is similar to that of Hib disease in the prevaccine era.

High rates of preventable diseases such as pneumococcal disease occur among the Navajo despite their universal health insurance through the Indian Health Service. The objective of this study was to determine the proportion of Navajo adults vaccinated with pneumococcal polysaccharide vaccine and to examine key features of vaccination programs of the Navajo Indian Health Service. For this cross-sectional study, medical charts of Navajo patients with vaccine indications were randomly selected and reviewed to determine who had been vaccinated as of January 1, 1999. Among 480 Navajo>or=65 years old, 73% were vaccinated (95% confidence interval [CI]: 69%-77%). Among 111 Navajo 18-64 years old with vaccine indications, 54% were vaccinated (95% CI: 45% -63%). Vaccination programs utilized extensive public health nursing, home visits, standing orders, and "express lane" clinics. In spite of excellent delivery systems and universal healthcare, the proportion of Navajo persons vaccinated was still below the goals for Healthy People 2010 of having 90% of persons>or=65 years old vaccinated and 60% of high-risk persons 18-64 years old vaccinated.

Streptococcus pneumoniae is the most common cause of invasive bacterial disease among children worldwide. The authors aimed to determine the incidence, clinical characteristics, and serotype distribution of invasive pneumococcal disease (IPD) among Navajo children in the southwestern United States. Active population-based laboratory surveillance for IPD among resident members of the Navajo Nation under 18 years of age was conducted between 1989 and 1996. During this 8-year period, 706 cases of IPD were identified. The rate of disease varied by age, with the highest rate being observed among children aged 6-11 months (727 cases/100,000 person-years), followed by children aged 0-11 months, 0-23 months, and 0-59 months (568, 537, and 272 cases/100,000 person-years, respectively). Among children aged 0-23 months, 60.3% of cases were caused by serotypes in the seven-valent conjugate pneumococcal vaccine (71.5% from 1989-1993 and 58.3% from 1994-1996). Navajo children are at increased risk of IPD in comparison with the general US population. The distribution of disease-causing serotypes is similar to that of many countries in the developing world. Prevention strategies should include the use of licensed pneumococcal protein conjugate vaccine; however, a substantial proportion of disease is caused by nonvaccine serotypes. These data are critical for assessing the impact of these vaccines in this high-risk population.

Background: Streptococcus pneumoniae is the main cause of invasive bacterial disease in children aged younger than 2 years. Navajo and White Mountain Apache children have some of the highest rates of invasive pneumococcal disease documented in the world. We aimed to assess the safety and efficacy of a seven-valent polysaccharide protein conjugate pneumococcal vaccine (PnCRM7) against such disease., Methods: In a group-randomised study, we gave this vaccine to children younger than 2 years from the Navajo and White Mountain Apache Indian reservations; meningococcal type C conjugate vaccine (MnCC) served as the control vaccine. Vaccine schedules were determined by age at enrollment. We recorded episodes of invasive pneumococcal disease and serotyped isolates. Analyses were by intention to treat and per protocol., Findings: 8292 children enrolled in the trial. In the per protocol analysis of the primary efficacy group (children enrolled by 7 months of age) there were eight cases of vaccine serotype disease in the controls and two in the PnCRM7 group; in the intention-to-treat analysis we noted 11 cases of vaccine serotype disease in the MnCC control group and two in the PnCRM7 group. After group randomisation had been controlled for, the per protocol primary efficacy of PnCRM7 was 76.8% (95% CI -9.4% to 95.1%) and the intention-to-treat total primary efficacy was 82.6% (21.4% to 96.1%)., Interpretation: PnCRM7 vaccine prevents vaccine serotype invasive pneumococcal disease even in a high risk population. Other regions with similar disease burden should consider including this vaccine in the routine childhood vaccine schedule.

A group-randomized, double-masked, phase III trial of a Streptococcus pneumoniae conjugate vaccine is being conducted in American Indian populations in the southwestern United States. Approximately 9000 infants will be enrolled in the primary efficacy cohort with vaccine allocation determined by community of residence. The trial is designed to continue until 48 cases of invasive pneumococcal disease due to vaccine serotypes have accumulated. Thirty-eight geographically and socially distinct areas were randomized within blocks formed by population size and geographic location. This design affords the opportunity to capture the effects of herd immunity (indirect effects) by estimating the impact of the vaccine intervention on nonimmunized infants. Group-randomized trials have challenging design and analysis features, many of which are discussed here in the context of the first such trial designed to lead to licensure of a drug or biologic in the United States.

Background: Oropharyngeal carriage studies of Haemophilus influenzae type b (Hib) and the rapid drop in Hib invasive disease in countries with widespread Hib conjugate vaccine immunization programmes for infants have indicated there may be significant indirect effects (herd immunity) associated with these vaccines. Our goal was to quantify the magnitude of these effects in an American Indian population during its early years of Hib immunization., Methods: In a synthetic case-cohort study, we combined data from an efficacy trial, an immunization uptake records survey, and ongoing surveillance for Hib disease on the Navajo Nation from 1988 to 1992. Decline in the incidence of invasive Hib disease among children <2 years old was estimated via proportional hazards survival models as a function of individual immunization status and the proportion of immunized children in a community., Results: The predominant vaccine during the study period was Hib-OMPC (92% of immunizations). The effectiveness of receipt of at least one dose was 97.2%. Compared to communities with 0-20% coverage with at least one dose, residence in communities with 20-40% and 40-60% coverage was associated with risk reductions of 56.5% and 73.2%, respectively., Conclusions: The results indicate substantial indirect effects of Hib-OMPC immunization may occur even at relatively low levels of immunization coverage. Countries that implement Hib immunization programmes may receive greater benefits at the community level than those due to the direct protection conferred to the individual through vaccination.

To understand the potential risk factors and protective factors for invasive Haemophilus influenzae type b (Hib) disease, we conducted a case-control study among Navajo children less than two years of age resident on the Navajo Nation. We analyzed household interview data for 60 cases that occurred between August 1988 and February 1991, and for 116 controls matched by age, gender, and geographic location. The Hib vaccine recipients were excluded from the analyses. Conditional logistic regression models were fit to examine many variables relating to social and environmental conditions. Risk factors determined to be important were never breast fed (odds ratio [OR] = 3.55, 95% confidence interval [CI] = 1.52, 8.26), shared care with more than one child less than two years of age (OR = 2.32, 95% CI = 0.91, 5.96); wood heating (OR = 2.14, 95% CI = 0.91, 5.05); rodents in the home (OR = 8.18, 95% CI = 0.83, 80.7); and any livestock near the home (OR = 2.18, 95% CI = 0.94, 5.04).

Acute diarrhoeal diseases continue to be a major health problem in certain underprivileged populations in the United States, including native Americans living in reservations. To describe the features of patients with diarrhoeal diseases requiring medical care, those attending the medical facilities of the Fort Apache Indian Reservation, Whiteriver, Arizona, were studied during 1981-1985. Clinical and aetiological information was obtained on 535 patients which constitute a 20% sample of those attending the outpatient clinic and all 386 patients who required 550 hospitalizations. Rotavirus, enterotoxigenic Escherichia coli, and Shigella were the most common aetiologic agents, a pattern similar to that seen in the developing countries. The clinical features of diarrhoeal illness and the frequent associated occurrence of acute respiratory symptoms, however, were remarkably similar, regardless of aetiology.

Acute diarrhoeal disease in children is known to be a major public health problem among native Americans living in reservations in the southwestern part of the United States. This study was undertaken to describe the epidemiology and causative agents of diarrhoea more completely, with the expectation that this information may help in the ultimate control of the disease in this population. Three interrelated epidemiologic studies were carried out in the White Mountain Apache Tribe, Whiteriver, Arizona, during 1981-1985: a three-year longitudinal study on a cohort of 112 newborns, a longitudinal two-year study in a cohort of 200 families, and a case-control study on 1,072 children with diarrhoea attending a medical facility. Both epidemiologic and microbiological patterns of diarrhoeal disease were found to be very similar to those seen in developing countries, indicating the need for basic improvements in sanitation and hygiene in this population.

We compared in 12- to 15-month-old American Indian infants the safety and immunogenicity of two licensed Haemophilus influenzae type b (Hib) conjugate vaccines, PRP-OMP (PedvaxHib) and HbOC (HibTITER), administered as booster vaccinations. All infants previously received PRP-OMP for their primary Hib vaccinations at 2 and 4 months of age. The geometric mean Hib antibody concentrations (microgram/ml) measured by radioactive antigen-binding assay for those receiving PRP-OMP (n = 17) or HbOC (n = 18) were 0.593 and 0.449, respectively, before boosting (P not significant) and 7.46 and 29.5 micrograms/ml, respectively, after boosting (P < 0.05). PRP-OMP recipients also had lower geometric mean IgG anti-Hib antibody concentrations than HbOC recipients (7.21 vs 28 micrograms/ml, P = 0.003) and lower bactericidal titers (3.18 vs. 15.4, not significant). We conclude that HbOC vaccine produced a significantly greater booster response than PRP-OMP vaccine when given at 12 to 15 months of age to children primed with two doses of PRP-OMP vaccine at 2 and 4 months of age.

Objective: In this article we determine the incidence and clinical spectrum of invasive pneumococcal disease in the White Mountain Apache population, a group known to have a high incidence of invasive disease due to Haemophilus influenzae type b., Design: Patients from whom cultures of normally sterile body sites yielded Streptococcus pneumoniae were identified retrospectively through review of hospital laboratory records from a 6.8-year period. Clinical data were reviewed and incidence rates were computed., Setting: The Whiteriver Indian Health Service Hospital is located on the 1.7-million-acre White Mountain Apache Reservation in eastern Arizona., Patients: Approximately 10,000 members of the White Mountain Apache Tribe reside on or near the reservation and receive health care through the Whiteriver Indian Health Service Hospital., Outcome Measures: The average annual incidence rates of invasive pneumococcal disease were calculated and clinical characteristics were reviewed., Results: One hundred thirty-eight cases of invasive pneumococcal disease were identified. The average annual incidence rate was 207 per 100,000 population, and 156 per 100,000 population when adjusted for age by direct standardization to the 1988 US population. The incidence rate was highest in children between 1 and 2 years--2396 per 100,000. The overall case-fatality rate was 5%. Pneumococcal pneumonia was the diagnosis in 79% of the patients 5 years of age or older. Alcohol abuse, identified in 66% of the cases in adults, was the most common underlying medical condition., Conclusion: The incidence rates in White Mountain Apaches are the highest reported for any population. A vaccine effective in children would greatly benefit this population.

Strains of Bacteroides fragilis which produce enterotoxin(s) (ETBF) have been associated with diarrhoeal diseases in young domestic animals and have also been isolated from humans with diarrhoea. We have determined epidemiologically that ETBF are significantly associated with diarrhoea in humans. We studied Apaches, primarily children, with diarrhoea attending an outpatient facility in Whiteriver, Arizona, from July 1986 through July, 1988. Stool cultures for isolation of ETBF and other diarrhoeal pathogens were taken from these persons as well as from age and time-matched control persons who did not have diarrhoea. ETBF were isolated significantly more often from persons with diarrhoea (12%) than from controls (6%), p = 0.03. Isolation was highest (20-24% of stool cultures positive) during the second and third years of life. The diarrhoeal syndrome associated with ETBF was non-specific, and most characteristic of a secretory, rather than inflammatory, type of diarrhoea. ETBF are significantly associated with acute diarrhoea in Apache children, and may be an important newly described cause of diarrhoea in humans.

The safety and immunogenicity of a Haemophilus influenzae type b polysaccharide conjugate vaccine linked to the outer membrane protein complex of Neisseria meningitidis (Hib-OMP) were evaluated among Apache and Navajo infants and children. One dose of the Hib-OMP was given to 42 children who were from 12 and 60 months of age. Ninety-two infants 6 to 8 weeks old were given one dose of Hib-OMP at the time of enrollment. A subsequent dose of the vaccine was given 2 months later and a third dose was offered between 12 and 15 months of age. All of the 12- to 60-month-old children achieved a protective antibody concentration (greater than 1 microgram/ml) 1 month postvaccination. Among the 6- to 8-week-old infants only 11% of the Apaches and 8% of Navajos had a protective anti-PRP antibody concentration prevaccination. One month post vaccination 68% of the Apaches and 69% of the Navajos had protective anti-PRP antibody concentrations. One month after the second immunization 67% of the Apaches and 75% of Navajos had protective anti-PRP concentrations. Among the infants that received the third (booster) immunization (N = 28) 74% had protective anti-PRP antibody titers just before the booster immunization. One month after the booster immunization all of the infants had protective concentrations of anti-PRP antibody. We conclude that the Hib-OMP is safe and highly immunogenic among Apache and Navajo infants and children.

A case-control study of rotavirus diarrhoea in Apache children up to two years old was conducted at the White Mountain Apache reservation from 1 May through 15 December 1985 to identify risk factors for rotavirus diarrhoea. The mothers of fifty cases, forty-five hospital controls and twenty-five neighbourhood controls participated in this study. Exposure to other children with diarrhoea stood out as the single most important factor for acquiring rotavirus diarrhoea (Odds ratio = 14.0). Other significant risk factors were living in homes with septic tanks and in homes with 'poor environmental sanitation.'. Minimizing contacts of children with diarrhoea therefore would be the most effective measure in preventing the spread of this disease in the community.

We used a solid-phase enzyme immunoassay to determine the age-specific rates of acquisition of antibody to Giardia lamblia in populations living in an inner city area of Baltimore, Md., on an Apache Indian reservation in Arizona, in a rural area of Panama, and in an urban area of Peru (Lima). Antibody to G. lamblia was found in a portion of the adults living in all of the study areas. Similar prevalence rates and quantitative levels of antibody were found in the adults living in Arizona (44%), Panama (48%), and Peru (46%). However, a significantly lower (P less than 0.05) percentage of the adults living in Baltimore (18%) displayed serological evidence of infection. Different patterns of age-associated acquisition of antibody were noted in the study populations. In the United States, children living in Baltimore had low levels of seropositivity throughout childhood, whereas children living on the Arizona Indian reservation showed a progressive acquisition of antibody early in childhood, with adult levels achieved by 8 years of age. In Latin America, children living in Panama attained adult levels of seropositivity between 9 and 20 years of age, whereas children in Peru displayed adult levels of seropositivity in the first 6 months of life. Our findings documented the widespread occurrence of G. lamblia infections in diverse populations. Children living in different areas and under different environmental conditions displayed widely differing rates of acquisition of antibody to G. lamblia, possibly resulting from different levels of sanitation, water contamination, and person-to-person contact. Our studies indicate that quantitative solid-phase immunoassays can be used to study the epidemiology of parasitic infections such as those caused by G. lamblia.

Based on a 10-year retrospective and a 15-month prospective analysis, White Mountain Apache Indian children younger than 5 years were found to have an annual incidence of Haemophilus influenzae meningitis of 254 cases/100,000--an 8-fold higher incidence than that seen in the general United States population. In our prospective surveillance, H. influenzae isolates from cases of systemic disease were further characterized by capsular type, biotype and by outer membrane protein (OMP) and lipopolysaccharide (LPS) patterns on sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE). Unexpectedly, H. influenzae type a strains were isolated in 3/18 cases of systemic disease. All other disease-producing strains were type b. H. influenzae b strains possessing common OMP, LPS, capsular and biotype characteristics were isolated from individuals in geographically distinct communities within the reservation. These apparently identical strains were isolated from different individuals who had systemic infections that occurred months apart (longest interval, 14 months). Both OMP and LPS subtyping were necessary to discriminate among invasive H. influenzae isolates.

Oral Rehydration Solutions (ORS) containing 90 and 50 mmol/L sodium have recently been recommended for use in ambulatory children in the U.S. These solutions are now marketed in powder form by some commercial companies. However, few data are available in the U.S. on the accuracy with which the solutions are mixed at home or on the bacterial contamination that may occur during mixing. We evaluated the effect of various forms of instructions on the occurrence of bacterial contamination and accuracy of mixing ORS at home by mothers of patients who were dispensed the dry ingredients of an ORS containing 90 mmol/L sodium at the U.S. Public Health Service Hospital, Whiteriver, Arizona. Patients were randomized to one of the four following groups: group I (23 patients) was given written instructions for mixing the solution along with a pre-marked container; group II (22 patients) was given written instructions only; group III (22 patients) was given a premarked container only; and group IV (19 patients) was given neither. All patients were given oral instructions in the preparation of ORS and were asked to refrigerate the reconstituted ORS. We collected samples of ORS at the patient's home 1 day after the clinic visit, to measure their electrolyte content and to identify any bacterial contamination. Mean Na+ concentrations were significantly lower in the ORS prepared by mothers/guardians in groups that were not given a premarked container [82 +/- 13 (II) and 79 +/- 21 (IV) mmol/L vs. 88 +/- 13 (I) and 92 +/- 14 (III) mmol/L; p less than 0.01].(ABSTRACT TRUNCATED AT 250 WORDS)

Rotaviral diarrhea is endemic in most areas of the world, yet community-wide epidemics have not been reported in prospectively monitored populations. This prospective study of the etiology of diarrhea included biweekly visits to the homes of 10% of the population of the White Mountain Apache Indians and began in April 1981. During a three-week period beginning 21 October, 1981, 342 new cases of diarrhea were identified on different parts of the reservation. Rotaviral antigen, detected by an enzyme-linked immunosorbent assay, was identified in 169 (73%) of the 233 stool samples that were tested. Rotavirus was not detected in any of the stool samples taken six months before or after the epidemic. During the epidemic, respiratory symptoms were present in 44 (33%) of 135 rotavirus-positive patients compared with 17 (17%) of 98 rotavirus-negative patients (P less than .05). This rapidly spreading epidemic involving all areas of the reservation, in the absence of a common source of exposure of ill persons, suggests the possibility of respiratory transmission.

We evaluated the safety and efficacy of a glycine-based orally administered rehydration solution by comparing it with a standard oral rehydration solution (ORS) without glycine in a randomized double-blind trial in United States infants (age less than 15 months) given treatment for acute gastroenteritis as inpatients or outpatients. The response to therapy (stool volume and duration of illness) was similar in the two groups, except that in four (13%) of 31 hospitalized infants receiving glycine-ORS hypernatremia developed, (one had symptoms) compared with none of 35 receiving ORS (P less than 0.04). Among the 77 outpatients there were no differences between the groups. This study demonstrates that glycine-ORS did not provide any therapeutic advantage over standard ORS, and hypernatremia developed in some patients receiving glycine-ORS. We suggest that caution be used with this type of solution until further safety studies have been done.

Apache Indian infants have a high frequency of Haemophilus influenzae type b (Hib) and pneumococcal infections. Forty percent of Hib infections in these infants occur before the age of six months, when active immunization may not be protective. To evaluate the efficacy of passive immunization with a human hyperimmune globulin (bacterial polysaccharide immune globulin [BPIG]) prepared from the plasma of immunized adult donors, we randomly assigned 703 infants in a double-blind fashion to receive 0.5 ml of BPIG per kilogram of body weight (n = 353) or 0.5 ml of saline (n = 350) intramuscularly at 2, 6, and 10 months of age. Hib-antibody levels were significantly higher in BPIG recipients than in placebo recipients at 4, 6, and 10 months of age (P less than 0.001). During the first 90 days after BPIG or placebo injection, no Hib or pneumococcal infections were detected in the BPIG group, whereas seven Hib infections (six cases of bacteremia and one of meningitis) and four pneumococcal infections (bacteremia) were detected in the placebo group (P = 0.007 and 0.06, respectively). During the fourth month, one case of Hib meningitis and two cases of pneumococcal bacteremia developed in the BPIG group, whereas there were no Hib or pneumococcal infections in the placebo group. We conclude that BPIG given at four-month intervals provided significant protection against serious Hib disease for three months, and that in high-risk infants it might be used alone, perhaps at three-month intervals, or together with active immunization.