Effect of Iron/Folic Acid Supplementation on the Outcome of Malaria Episodes Treated with Sulfadoxine-Pyrimethamine

Folic acid supplementation may potentially alter the efficacy of sulfadoxine-pyrimethamine (SP) treatment in children with malaria. However, there is lack of evidence fromrandomized controlled trials and effects of folic acid supplementation on clinical efficacy of SP therapy remainmoderately understood among children. In a doublemasked, placebo-controlled trial among preschool children in Pemba Island (Tanzania), iron and folic acid supplementation (Fe/FA) showed an increased risk of hospitalizations and death. In the present paper, we evaluated if folic acid supplementation reduced the efficacy of malaria treatment and thereby contributed to observed adverse effects. During the study, 1648 children had confirmed malarial episodes and received either sulphadoxinepyrimethamine(SP) treatment and iron folic acid or SP treatment and placebo. These children were evaluated for recovery and incidence of hospitalization during the next 15, 30, and 140 days. Two groups did not differ in malarial episode or hospitalization rate on subsequent 15, 30, and 140 days. Altered efficacy of SP by folic acid was not observed and did not contribute to adverse events in the previous trial.This trial is registered with Controlled-trials.com ISRCTN59549825

Chlorhexidine cleansing of the umbilical cord stump and risk of omphalitis and neonatal death

Background: Sub-Saharan Africa and South Asia account for 80% of all neonatal deaths in the world. In these two regions, infectious diseases account for one third of neonatal deaths. Early neonatal sepsis is a major contributor to the high neonatal morbidity and mortality and umbilical cord stump infection (omphalitis) is postulated to be a potential precursor to neonatal sepsis. There has been evidence from Asia to suggest that CHX application to the umbilical cord stump can reduce the risk of omphalitis as well as neonatal death. No data on the efficacy of CHX cord care in Africa were available before we embarked on the studies described in this thesis. The studies in this thesis address four main topics: i) understanding childbirth and newborn care knowledge, attitudes and practices (KAP); ii) feasibility, acceptance and compliance with different modes of CHX application on the umbilical cord stump; iii) effect of the proposed CHX formulation on bacterial colonization of the cord stump; and iv) efficacy of CHX application on the risk of omphalitis and neonatal death. Methods: Two qualitative studies were conducted in Pemba, a part of the Zanzibar archipelago of Tanzania. The first study explored the KAP regarding childbirth, newborn and umbilical cord care and probed barriers and facilitators to introduction of CHX cord care. A total of 80 in-depth interviews (IDIs) and 11 focus group discussions (FGDs) involving mothers, grandmothers, fathers, traditional birth attendants (TBAs) and health service providers were undertaken. A second study, using the Trials of Improved Practices (TIPs) methodology investigated the feasibility, acceptance, and compliance with three possible modes of CHX application. The third study tested the effect of a commercially prepared 4% CHX solution on bacterial colonization in New Delhi. The fourth study was a large community-based randomized control trial (RCT) in Pemba to estimate the efficacy of CHX cleansing of the umbilical cord stump on the risk of omphalitis and neonatal death. The RCT was implemented in two phases. During Phase 1, the study participants were randomly allocated to one of three intervention arms: the treatment arm using CHX, one control arm using a placebo solution and a second control arm practicing dry cord care. During Phase 2, the placebo arm of the trial was dropped, and the participants were randomized to receive either CHX or dry cord care. For babies allocated to the CHX and the placebo arms, mothers/caregivers were advised to apply the solution to the cord stump every day until 3 days after the cord stump had fallen off. For babies assigned to the dry cord care arm, TBAs and hospital staff instructed the mothers/caregivers not to cleanse the umbilical cord stump and to keep it dry. In all trial arms, the cord was examined for redness, pus, swelling and/or foul smell on days 0, 1, 4, 10 and 28. Findings: The qualitative study showed that the awareness among the community members regarding the importance of facility-based births was high. However, impediments such as lack of transportation; cost of medicines and quality of care at the facilities seemed to be a reason for many women choosing to give birth at home. Some of the reported good practices included use of clean delivery instruments, TBAs’ emotional and physical support to mothers, newborn warming and feeding of colostrum. Some behaviors that could undermine newborn health, such as immediate bathing of newborns, poor hand hygiene of TBAs, exposing the newborn to smoke for warming, application of some traditional substances on the cord stump were also reported by some participants. CHX cord stump cleansing was an acceptable and feasible intervention and could be easily applied by family members after some initial training. The second study revealed that mothers and health service providers preferred a single use dropper bottle for CHX application as compared to either a 100 ml multiple use bottle with cotton swabs or a gel tube. The third study showed that cord stump cleansing with 4% CHX soon after birth substantially reduced bacterial colonization. The large efficacy trial found that CHX cleansing resulted in a large reduction in the risk of omphalitis (Relative risk (RR): 0.65; 95% Confidence interval (CI) 0.61 to 0.70). The mortality in the dry cord care arm was lower than anticipated, and any effect of CHX on neonatal mortality was small (RR: 0.90; 95% CI 0.74 to 1.09). Any effect of CHX application on the risk of death did not differ by whether the babies were born at home (RR: 0.92; 95% CI 0.67 to 1.27) or in a health facility (RR: 0.89; 95% CI 0.70 to 1.14). Conclusion: CHX cleansing of the cord stump, while acceptable to mothers and families markedly reduced the risk of omphalitis but this reduction did not translate into a substantial decrease in the risk of neonatal death in this East African settingDoktorgradsavhandlin

Impact of micronutrient fortification of yoghurt on micronutrient status markers and growth – a randomized double blind controlled trial among school children in Bangladesh

BACKGROUND: Interventions providing foods fortified with multiple micronutrients can be a cost-effective and sustainable strategy to improve micronutrient status and physical growth of school children. We evaluated the effect of micronutrient-fortified yoghurt on the biochemical status of important micronutrients (iron, zinc, iodine, vitamin A) as well as growth indicators among school children in Bogra district of Bangladesh. METHODS: In a double-masked randomized controlled trial (RCT) conducted in 4 primary schools, 1010 children from classes 1–4 (age 6–9 years) were randomly allocated to receive either micronutrient fortified yoghurt (FY, n = 501) or non-fortified yoghurt (NFY, n = 509). For one year, children were fed with 60 g yoghurt everyday providing 30% RDA for iron, zinc, iodine and vitamin A. Anthropometric measurements and blood/urine samples were collected at base-, mid- and end-line. All children (FY, n = 278, NFY, n = 293) consenting for the end-line blood sample were included in the present analyses. RESULTS: Both groups were comparable at baseline for socio-economic status variables, micronutrient status markers and anthropometry measures. Compliance was similar in both the groups. At baseline 53.4% of the population was anemic; 2.1% was iron deficient (ferritin <15.0 μg/L and TfR > 8.3 mg/L). Children in the FY group showed improvement in Hb (mean difference: 1.5; 95% CI: 0.4-2.5; p = 0.006) as compared to NFY group. Retinol binding protein (mean diff: 0.05; 95% CI: 0.002-0.09; p = 0.04) and iodine levels (mean difference: 39.87; 95% CI: 20.39-59.35; p < 0.001) decreased between base and end-line but the decrease was significantly less in the FY group. Compared to NFY, the FY group had better height gain velocity (mean diff: 0.32; 95% CI: 0.05-0.60; p = 0.02) and height-for-age z-scores (mean diff: 0.18; 95% CI: 0.02-0.33; p = 0.03). There was no difference in weight gain velocity, weight-for-age z-scores or Body Mass Index z-scores. CONCLUSION: In the absence of iron deficiency at baseline the impact on iron status would not be expected to be observed and hence cannot be evaluated. Improved Hb concentrations in the absence of a change in iron status suggest improved utilization of iron possibly due to vitamin A and zinc availability. Fortification improved height gain without affecting weight gain. TRIAL REGISTRATION: ClinicalTrial.gov: NCT0098073

Ferron as an Analytical Reagent for Extractive Separation of Molybdenum

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Validation of Visual Estimation of Portion Size Consumed as a Method for Estimating Food Intake by Young Indian Children

In this observational study, estimation of food intake was evaluated using recording of portion size consumed, instead of post-weighing, as a method. In total, 930 feeding episodes were observed among 128 children aged 12–24 months in which actual intake was available by pre- and post-weighing. For each offering and feeding episode, portion size consumed was recorded by an independent nutritionist—as none, less than half, half or more, and all. Using the pre-weighed offering, available intake was estimated by multiplying portion sizes by the estimated weight. The estimated mean intake was 510.4 kilojoules compared to actual intake of 510.7 kilojoules by weighing. Similar results were found with nestum (52.0 vs 56.2 g), bread (3.8 vs 3.7 g), puffed rice (1.7 vs 1.9 g), banana (31.3 vs 24.4 g), and milk (41.6 vs 44.2 mL). Recording portion size consumed and estimating food intake from that provides a good alternative to the time-consuming and often culturally-unacceptable method of post-weighing food each time after a feeding episode

Zinc Deficiency: Descriptive Epidemiology and Morbidity among Preschool Children in Peri-urban Population in Delhi, India

Community-based data relating to factors influencing zinc deficiency among preschool children in India are inadequate. Data of a large, double-blinded, randomized, controlled zinc-supplementation trial were used for assessing the descriptive epidemiology of zinc deficiency among children aged 6–35 months (n=940). In total, 609 children were followed up for 120 days for information on morbidity. Of these children, 116 from the control group belonging to the upper and the lower 25th quartile of plasma zinc status at baseline were selected for assessing the association of zinc deficiency with prospective morbidity. At baseline, demographic, socioeconomic and dietary information was collected, and anthropometric measurements and levels of plasma zinc were assessed. At baseline, 73.3% of the children were zinc-deficient (plasma zinc <70 µg/dL), of which 33.8% had levels of plasma zinc below 60 µg/dL. A significantly higher risk of morbidity was prevalent among the subjects with lower plasma zinc compared to those with higher levels of plasma zinc

Facility Selection Model for BOPS Service for an Omnichannel Retail Chain

Retail sector around the world is going through a transition due to digitalization. Customers now demand convenience of online channel with instant fulfillment of offline channel. As a result, the concept of omnichannel retailing has come into existence. In omnichannel retailing, both the channels of a firm are fully or partially integrated. There are many strategies that may be developed by retailers for efficient functioning of the omnichannel retail chain. The choice of such a strategy depends upon the comparative benefits that can be derived from them. One such strategy gaining immense attention of retailers is the Buy Online Pickup in Store (BOPS) strategy. In order to understand this BOPS, we conducted a detail case study of an Indian multichannel retail chain who is considering the option of launching BOPS option in few of its retail stores. The focus is to evaluate and select a fixed number of operational retail stores to also act as pick-up points for online deliveries. K-means clustering is utilized for the formation of retail zones as per the number of retail stores to be selected. The retail stores in each zone are evaluated on the basis of a number of criteria such as demand, inventory carrying capacity, cost, and population characteristics using analytical hierarchy process and complex proportional assessment-grey. Based on these evaluations, the best suitable retail store is selected for expansion from each zone. The result implications drawn in the study can provide an understanding of the future strategies that can be developed by the decision makers of the firm for launching the BOPS option. This article can also be beneficial to other Indian retail firms who can derive meaningful insights from the findings.</p

Neonatal mortality within 24 hours of birth in six low- and lower-middle-income countries.

OBJECTIVE: To estimate neonatal mortality, particularly within 24 hours of birth, in six low- and lower-middle-income countries. METHODS: We analysed epidemiological data on a total of 149 570 live births collected between 2007 and 2013 in six prospective randomized trials and a cohort study from predominantly rural areas of Bangladesh, Ghana, India, Pakistan, the United Republic of Tanzania and Zambia. The neonatal mortality rate and mortality within 24 hours of birth were estimated for all countries and mortality within 6 hours was estimated for four countries with available data. The findings were compared with published model-based estimates of neonatal mortality. FINDINGS: Overall, the neonatal mortality rate observed at study sites in the six countries was 30.5 per 1000 live births (range: 13.6 in Zambia to 47.4 in Pakistan). Mortality within 24 hours was 14.1 per 1000 live births overall (range: 5.1 in Zambia to 20.1 in India) and 46.3% of all neonatal deaths occurred within 24 hours (range: 36.2% in Pakistan to 65.5% in the United Republic of Tanzania). Mortality in the first 6 hours was 8.3 per 1000 live births, i.e. 31.9% of neonatal mortality. CONCLUSION: Neonatal mortality within 24 hours of birth in predominantly rural areas of six low- and lower-middle-income countries was higher than model-based estimates for these countries. A little under half of all neonatal deaths occurred within 24 hours of birth and around one third occurred within 6 hours. Implementation of high-quality, effective obstetric and early newborn care should be a priority in these settings

Effect of Zinc Added to Multivitamin Supplementation Containing Low-dose Vitamin A on Plasma Retinol Level in Children—A Double-blind Randomized, Controlled Trial

In a community-based double-blind randomized trial in children aged 6–35 months, both intervention and control groups received a multi-vitamin syrup containing vitamin A, while the intervention group had zinc gluconate (equivalent to 10 mg of elemental zinc) additional in the syrup. There was a significant decrease in diarrhoea and pneumonia in the intervention group. This study was undertaken to investigate if addition of zinc to vitamin A had improved plasma retinol levels, which, in turn, was responsible for the effects observed in the intervention group. In a randomly-selected subsample of 200 children—100 each from the intervention and the control group, plasma retinol levels after 120 days of supplementation were measured. There was no difference in the mean plasma retinol levels [the difference in the mean 0.46 μg/dL (95% confidence interval -1.42–2.36)] between the two groups following supplementation. No difference in plasma retinol levels was observed in the subgroups based on baseline nutritional status and plasma zinc levels. Addition of zinc to low-dose vitamin A in this study did not improve the vitamin A status of children and cannot explain morbidity effects of the intervention

Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India: a randomized controlled study

BACKGROUND: Infections are the single most important cause of neonatal mortality in developing countries. Results from trials in Asia evaluating the effect of chlorhexidine on neonatal mortality have been encouraging but limited data are available on the impact of cord cleansing on bacterial colonization. Further, no data from facility deliveries and impact with time is available. This pilot study was aimed to evaluate the impact of 4 % commercially prepared chlorhexidine on cord colonization and density of colonization among newborns in India. METHODS: Three hundred twenty-six newborns (hospital-247; community-79) were enrolled within 24 h of birth and randomly assigned to one of three groups: chlorhexidine, placebo or dry cord care. Umbilical swabs were collected at baseline, 2- and 48- hours after intervention application. RESULTS: At baseline, growth positivity (any bacterial growth) was 20 % (50 of 247 swabs) and 81 % (64 of 79 swabs) among hospital and community born neonates, respectively. In both settings, chlorhexidine compared to placebo and dry cord care, reduced colonization following 2- and 48-hour post application. Chlorhexidine significantly reduced 48-hour post application colony counts in comparison to placebo [Hospital: mean difference = −1.01; 95 % CI: −1.72, −0.30 Community: mean difference = −1.76; 95 % CI: −2.60, −0.93] and dry cord care [Hospital: mean difference = −1.16; 95 % CI: −1.93, −0.39 Community: mean difference = −2.23; 95 % CI: −3.18, −1.29]. Differences were similar for gram-positive and gram-negative bacteria. CONCLUSIONS: Cord cleansing with 4 % chlorhexidine soon after birth reduced colonization as well as density of colonization significantly; however this pilot study does not address the impact of chlorhexidine on mortality. The control preparation neither increased or decreased colonization. TRIAL REGISTRATION: Clinical Trial Registration: clinicaltrials.gov: NCT01528852, Registered February 7, 2012. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12887-016-0625-7) contains supplementary material, which is available to authorized users