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Biomedical subjects

M Santosham

Publications and source records attributed to M Santosham.

At least 19 recordsLinked to original sources
PubMed2006

Introduction of community-based skin-to-skin care in rural Uttar Pradesh, India.

OBJECTIVE: Two-thirds of women globally give birth at home, yet little data are available on use of skin-to-skin care (STSC) in the community. We describe the acceptability of STSC in rural Uttar Pradesh, India, and measured maternal, newborn, and ambient temperature in the home in order to inform strategies for introduction of STSC in the community. STUDY DESIGN: Community-based workers in intervention clusters implemented a community mobilization and behavior change communication program that promoted birth preparedness and essential newborn care, including adoption of STSC, with pregnant mothers, their families, and key influential community members. Acceptance of STSC was assessed through in-depth interviews and focus groups, and temperature was measured during home visits on day of life 0 or 1. RESULTS: Incidence of hypothermia (<36.5 degrees C) was high in both low birth weight (LBW) and normal birth weight (NBW) infants (49.2%, (361/733) and 43% (418/971), respectively). Mean body temperature of newborns was lower (P<0.01) in ambient temperatures <20 degrees C (35.9+/-1.4 degrees C, n=225) compared to > or =20 degrees C (36.5+/-0.9 degrees C, n=1450). Among hypothermic newborns, 42% (331/787) of their mothers had a lower temperature (range -6.7 to 0.1 degrees C, mean difference 0.4+/-1.2 degrees C). Acceptance of STSC was nearly universal. No adverse events from STSC were reported. STSC was perceived to prevent newborn hypothermia, enhance mother's capability to protect her baby from evil spirits, and make the baby more content. CONCLUSION: STSC was highly acceptable in rural India when introduced through appropriate cultural paradigms. STSC may be of benefit for all newborns and for many mothers as well. New approaches are needed for introduction of STSC in the community compared to the hospital.

Body Temperature Regulation↗
PubMed2006

Evaluation of the indirect effects of a pneumococcal vaccine in a community-randomized study.

When a sufficiently high proportion of a population is immunized with a vaccine, reduction in secondary transmission of disease can confer significant protection to unimmunized population members. We propose a straightforward method to estimate the degree of this indirect effect of vaccination in the context of a community-randomized vaccine trial. A conditional logistic regression model that accounts for within-randomization unit correlation over time is described, which models risk of disease as a function of community-level covariates. The approach is applied to an example data set from a pneumococcal conjugate vaccine study, with study arm and immunization levels forming the covariates of interest for the investigation of indirect effects.

Child, Preschool↗
PubMed2006

Rates, timing and causes of neonatal deaths in rural India: implications for neonatal health programmes.

OBJECTIVE: To assess the rates, timing and causes of neonatal deaths and the burden of stillbirths in rural Uttar Pradesh, India. We discuss the implications of our findings for neonatal interventions. METHODS: We used verbal autopsy interviews to investigate 1048 neonatal deaths and stillbirths. FINDINGS: There were 430 stillbirths reported, comprising 41% of all deaths in the sample. Of the 618 live births, 32% deaths were on the day of birth, 50% occurred during the first 3 days of life and 71% were during the first week. The primary causes of death on the first day of life (i.e. day 0) were birth asphyxia or injury (31%) and preterm birth (26%). During days 1-6, the most frequent causes of death were preterm birth (30%) and sepsis or pneumonia (25%). Half of all deaths caused by sepsis or pneumonia occurred during the first week of life. The proportion of deaths attributed to sepsis or pneumonia increased to 45% and 36% during days 7-13 and 14-27, respectively. CONCLUSION: Stillbirths and deaths on the day of birth represent a large proportion of perinatal and neonatal deaths, highlighting an urgent need to improve coverage with skilled birth attendants and to ensure access to emergency obstetric care. Health interventions to improve essential neonatal care and care-seeking behavior are also needed, particularly for preterm neonates in the early postnatal period.

Adolescent↗
PubMed2002

Nasopharyngeal carriage of resistant pneumococci in young South Indian infants.

Streptococcus pneumoniae is the leading bacterial cause of life-threatening infections in infants. Although antibiotic resistance affects management of pneumococcal infections, few data on patterns of resistance are available for India. We examined nasopharyngeal carriage of antibiotic-resistant pneumococci in 464 South Indian infants between 2 and 6 months. Newly acquired serotypes were screened for susceptibility to cotrimoxazole, erythromycin and penicillin using disk diffusion. Cumulative prevalence of pneumococcal carriage rose from 53.9% at 2 months to 70.2% at 6 months. The prevalence of strains that were not susceptible to penicillin, cotrimoxazole and erythromycin was 34, 81.1 and 37.2%, respectively. Carriage of erythromycin non-susceptible strains declined significantly between ages 4 months and 6 months (44.1 vs. 10.7%). More than 87% of the isolates screened were non-susceptible to > or = 1 antibiotic. Serogroups/types that were most frequently non-susceptible to 1 or more antibiotics were 6, 9, 14, 19 and 23. Less than 1% of the isolates were multi-drug resistant. Widespread use of antibiotics in South India has resulted in S. pneumoniae becoming non-susceptible to some commonly used antibiotics. Monitoring trends in antibiotic susceptibility and making antibiotics available only through prescription from a health care worker may slow the spread of resistant pneumococci and improve management of pneumococcal infections in South India.

Carrier State↗
PubMed2002

Impact of topical oils on the skin barrier: possible implications for neonatal health in developing countries.

UNLABELLED: Topical therapy to enhance skin barrier function may be a simple, low-cost, effective strategy to improve outcome of preterm infants with a developmentally compromised epidermal barrier, as lipid constituents of topical products may act as a mechanical barrier and augment synthesis of barrier lipids. Natural oils are applied topically as part of a traditional oil massage to neonates in many developing countries. We sought to identify inexpensive, safe, vegetable oils available in developing countries that improved epidermal barrier function. The impact of oils on mouse epidermal barrier function (rate of transepidermal water loss over time following acute barrier disruption by tape-stripping) and ultrastructure was determined. A single application of sunflower seed oil significantly accelerated skin barrier recovery within 1 h; the effect was sustained 5 h after application. In contrast, the other vegetable oils tested (mustard, olive and soybean oils) all significantly delayed recovery of barrier function compared with control- or Aquaphor-treated skin. Twice-daily applications of mustard oil for 7 d resulted in sustained delay of barrier recovery. Moreover, adverse ultrastructural changes were seen under transmission electron microscopy in keratin intermediate filament, mitochondrial, nuclear, and nuclear envelope structure following a single application of mustard oil. CONCLUSION: Our data suggest that topical application of linoleate-enriched oil such as sunflower seed oil might enhance skin barrier function and improve outcome in neonates with compromised barrier function. Mustard oil, used routinely in newborn care throughout South Asia, has toxic effects on the epidermal barrier that warrant further investigation.

Administration, Topical↗
PubMed2001

Design of a group-randomized Streptococcus pneumoniae vaccine trial.

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.

Arizona↗
PubMed2001

Pneumococcal nasopharyngeal colonization in young South Indian infants.

BACKGROUND: Streptococcus pneumoniae is the most frequent bacterial cause of morbidity and mortality in young children. Bacteria carried in the nasopharynx of healthy children reflect the prevalent strains circulating in the community. METHODS: We recruited 464 newborns from a rural area in South India with endemic vitamin A deficiency. Nasopharyngeal specimens were collected from each infant at ages 2, 4 and 6 months. RESULTS: Fifty-four percent of study infants were colonized by age 2 months, with 64.1 and 70.2% carriage prevalence at ages 4 and 6 months, respectively. The odds of carriage at 2 months were significantly increased in female infants, infants living in a household in which 20 or more cigarettes were smoked each day, infants whose mothers had less than 1 year of schooling and infants fed colostrum. At age 4 months infants having 2 or more siblings <5 years of age were at significantly increased risk of carriage. At age 6 months none of the potential risk factors examined achieved statistical significance, but maternal night blindness increased the risk of colonization 3-fold. The odds of carrying a PncCRM197 vaccine serotype were increased among infants born to mothers who experienced night blindness during pregnancy. The most prevalent serogroups/types during the first 6 months of life were 6, 9, 10, 11, 14, 15, 19, 23 and 33, accounting for 76.7% of all serotyped isolates. CONCLUSIONS: South Indian infants experience high rates of pneumococcal carriage during the first 6 months of life, which may partially explain their increased risk for pneumonia.

Age Factors↗
PubMed2001

Typhoid fever in Bangladesh: implications for vaccination policy.

OBJECTIVE: To describe the age-specific distribution of typhoid fever including the degree of Salmonella typhi bacteremia among patients evaluated at a large private diagnostic center in Bangladesh, a highly endemic area. METHODS: We conducted a prospective-, passive- and laboratory-based study to identify patients with S. typhi bacteremia. Subjects (n = 4,650) from whom blood cultures were obtained during 16-month period were enrolled from private clinics and hospitals throughout Dhaka. Isolation and quantification of S. typhi from blood cultures were performed by the lysis direct plating/ centrifugation method. RESULTS: Bacterial pathogens were recovered from blood of 538 of 4,650 patients (11.6%) evaluated. S. typhi was the single most common pathogen recovered, comprising nearly three-fourths of isolates (72.7%; 391 of 538). Isolation rate of S. typhi was highest in monsoon and summer seasons and lowest in winter months. The majority (54.5%; 213 of 391) of S. typhi isolates were from children who were younger than 5 years, and 27% (105 of 391) were from children in the first 2 years of life. The isolation rate was highest (17.4%, 68 of 486) in the second year of life. The number of bacteria in blood on the basis of colony-forming units per ml of blood by age group was inversely related to age. CONCLUSIONS: Detection of S. typhi bacteremia in young children in Dhaka, Bangladesh, was considerably higher than previously appreciated, with a peak detection rate in children < or =2 years of age, indicating the need to reassess the age-specific burden of typhoid fever in the community on a regional basis. Contrary to current recommendations this study suggests that development of new vaccines should target infants and young children.

Adolescent↗
PubMed2001

Safety and antibody persistence following Haemophilus influenzae type b conjugate or pneumococcal polysaccharide vaccines given before pregnancy in women of childbearing age and their infants.

BACKGROUND: Immunization of healthy women before pregnancy is a potential approach to providing increased levels of maternal antibody to newborns to protect them from infections occurring during the perinatal period and first months of life. METHODS: Healthy nonpregnant Pima Indian women of childbearing age were randomized to receive one of two Haemophilus influenzae type b (Hib) conjugate vaccines [HbOC or Hib-meningococcal outer membrane protein complex (OMP)] or a 23-valent pneumococcal polysaccharide vaccine (PnPs). Infants received Hib-OMP vaccine at 2, 4 and 12 months of age. Vaccine safety and immunogenicity was evaluated in the women and their infants. RESULTS: Anti-polyribose ribitol phosphate antibody titers were significantly higher in women in both Hib conjugate vaccine groups than in the pneumococcal vaccine group throughout the 37-month observation period. Antibody responses to HbOC vaccine were significantly higher than those to Hib-OMP. A subsequent booster dose of each Hib conjugate vaccine induced reactions and antibody responses similar to those of the first dose. Infants born to mothers immunized with Hib vaccines compared with PnPs had significantly higher polyribose ribitol phosphate-specific IgG antibody titers at birth and 2 months of age but lower antibody responses to Hib-OMP at 6 months and similar titers before and after boosting with Hib-OMP at 1 year of age. By contrast women immunized with PnPs did not have significantly elevated concentrations of pneumococcal-specific antibody at delivery, and their infants had pneumococcal antibody titers similar to those of infants born to mothers who did not receive pneumococcal vaccine before pregnancy. CONCLUSION: Hib conjugate vaccine given to women before pregnancy significantly increased the proportion of infants who had protective Hib antibody levels at birth and 2 months of age.

Adolescent↗
PubMed2001

Rapid identification and antibiotic susceptibility testing of Salmonella enterica serovar Typhi isolated from blood: implications for therapy.

The turnaround time (TAT) for Salmonella enterica serovar Typhi identification and reporting of the antibiotic susceptibility profile was determined for 391 cases of typhoid fever, using the lysis direct plating or lysis centrifugation method of blood culture along with rapid antimicrobial susceptibility testing. The TAT was more rapid (TAT for 90% of the patients [TAT(90)] = 30 h; TAT(100) </= 67 h) than was possible with conventional methodologies and was equivalent to that reported previously using more advanced, costly technologies that are largely unavailable in developing countries. Antibiotic susceptibility profiles, determined by the rapid antimicrobial susceptibility testing method, of randomly selected 60 S. enterica serovar Typhi isolates were identical to those determined by overnight conventional testing. Preliminary assessment of the impact of the reduced TAT on physician practices revealed that initial empirical therapy was prescribed at the time of presentation in most cases (87 of 108 [81%]) despite awareness that the final report would be available on the following day. Patients treated empirically with first-line antibiotics and shown subsequently to be infected with a multidrug-resistant strain benefited most (8 cases), since therapy was changed appropriately on the following day. In an additional 21 cases, therapy with an appropriate antibiotic was initiated after culture results were available. Thus, in approximately one-fourth (29 of 108 [27%]) of the cases, a change in management to an agent active for treatment of the isolate was made after receipt of the test results. However, in no case was therapy changed from a second-line to a first-line agent, even if the isolate was reported on the day after presentation to be sensitive to first-line therapy (33 cases). Ways in which to utilize rapid-TAT result reporting in order to positively influence physicians' prescribing in Bangladesh are the subject of ongoing research.

Adolescent↗
PubMed2000

Immunogenicity of a heptavalent pneumococcal conjugate vaccine in Apache and Navajo Indian, Alaska native, and non-native American children aged <2 years.

High rates of invasive pneumococcal disease have been described among infants living in various Native American communities. In this study, we evaluated the immunogenicity of a 7-valent pneumococcal vaccine consisting of serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F covalently linked to the outer membrane protein complex of Neisseria meningitidis in Apache and Navajo Indian, Alaska Native, and non-Native American children. The vaccine was administered at ages 2, 4, and 6 months; a booster dose was given at age 15 months. Levels of serotype-specific immunoglobulin G (IgG) were measured by a standardized enzyme-linked immunosorbent assay. The responses after 3 primary doses of vaccine were similar in all 3 groups of children, except for those to serotypes 14 and 23F. One month after the booster dose, geometric mean concentrations (GMCs) of serotype-specific IgG antibodies increased significantly in all 3 groups of children, compared with GMCs of IgG antibodies to pneumococcal serotypes before the booster dose.

Antibodies, Bacterial↗
PubMed2000

The World Health Organization oral rehydration solution in US pediatric practice: a randomized trial to evaluate parent satisfaction.

BACKGROUND: The World Health Organization's effective, inexpensive oral rehydration solution (WHO-ORS) is used worldwide, but rarely by US practitioners because, in part, of concerns about parent satisfaction. OBJECTIVE: To compare caretaker satisfaction with the WHO-ORS, a packet-based solution requiring preparation, with satisfaction with a commercially prepared oral rehydration solution (C-ORS), (Pedialyte; Ross Nutritionals, Columbus, Ohio). DESIGN AND METHODS: Randomized controlled trial in an urban pediatric clinic and a suburban family medicine clinic. Children aged 3 to 47 months treated as outpatients for diarrhea were randomized to receive either WHO-ORS or C-ORS. After 48 hours of use, caretakers completed a telephone interview measuring satisfaction with aspects of the solution. RESULTS: Of 97 families enrolled, 91 (94%) were available for follow-up interviews. The WHO-ORS and C-ORS groups were comparable at baseline in all respects, except that slightly more caretakers in the latter group had used the C-ORS for the current illness before study enrollment (P= .06). Caretakers in the WHO-ORS group had higher overall satisfaction, satisfaction with cost, willingness to purchase in the future, and to recommend use (P<.001 for all). Differences remained significant after controlling for prior use of the C-ORS. There was no difference in satisfaction with ease of administration (P=.90), appearance (P=.20), and effectiveness (P=.80). No adverse effects attributable to either study solution occurred. CONCLUSIONS: Caretakers who prepared and used the WHO-ORS were more satisfied with their solution than a comparable group who administered C-ORS. Fear of parental dissatisfaction need not be a barrier to use of the WHO-ORS in the United States.

Child, Preschool↗
PubMed2000

Estimation of the indirect effect of Haemophilus influenzae type b conjugate vaccine in an American Indian population.

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.

Arizona↗
PubMed2000

Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM(197) among infants with sickle cell disease. Pneumococcal Conjugate Vaccine Study Group.

OBJECTIVES: To determine the immunogenicity and safety of heptavalent pneumococcal polysaccharide vaccine (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) conjugated to CRM(197) (7-valent conjugate pneumococcal vaccine [7VPnC]) among infants with sickle cell disease (SCD) and a comparison group of infants without SCD (non-SCD). DESIGN: Two cohorts of infants were enrolled and received open-label doses of 7VPnC vaccine; infants enrolled before 2 months of age received 7VPnC vaccine at 2, 4, and 6 months of age followed by 23-valent pneumococcal polysaccharide vaccine (PS-23) at 24 months of age for those infants with SCD (schedule A), and infants enrolled between 2 and 12 months of age received 7VPnC at 12 months of age followed by PS-23 at 24 months of age for infants with SCD (schedule B). Safety data were collected for 3 days after each dose of vaccine. Antibody concentrations were measured to each of the 7VPnC serotypes by enzyme-linked immunosorbent assay before each vaccine dose and 1 month after the last 7VPnC dose and the PS-23 vaccine dose. RESULTS: Forty-five infants (34 SCD and 11 non-SCD) were vaccinated according to schedule A and 16 infants (13 SCD and 3 non-SCD) according to schedule B. The 7VPnC vaccine was highly immunogenic for all serotypes among infants with and without SCD who received 3 doses of vaccine according to schedule A: depending on serotype, 89% to 100% achieved antibody concentrations above.15 microg/mL and 56% to 100% achieved antibody concentrations above 1.0 microg/mL. Among infants immunized according to schedule B, a single dose of 7VPnC vaccine resulted in antibody concentrations above.15 microg/mL in 53% to 92% by serotype and above 1.0 microg/mL in 31% to 71% by serotype. A single dose of PS-23 resulted in dramatic increases in the antibody concentrations to all serotypes regardless of 1- or 3-dose priming. There was no difference in the reactogenicity of the 7VPnC vaccine between those with and without SCD. There were no serious reactions to the 7VPnC or PS-23 vaccines, even among those with high antibody concentrations before immunization. CONCLUSIONS: Infants with SCD respond to 7VPnC vaccine with antibody concentrations that are at least as high as infants without SCD. Infants immunized with 7VPnC vaccine at 2, 4, and 6 months of age developed antibody concentrations in the same range as those achieved among infants without SCD enrolled in a large trial that demonstrated vaccine efficacy against invasive disease. Significant rises were seen in antibody concentrations to all 7VPnC serotypes after the PS-23 booster in children receiving schedule A or B.

Anemia, Sickle Cell↗