Infectious Diseases - Research Publications
Permanent URI for this collection
Search Results
1 - 10 of 23
-
ItemProtocol for a randomised, multicentre, four-arm, double-blinded, placebo-controlled trial to assess the benefits and safety of iron supplementation with malaria chemoprevention to children in Malawi: IRMA trial(BMJ PUBLISHING GROUP, 2023-10)INTRODUCTION: Approximately 40% of children aged 6-59 months worldwide are anaemic. Iron-containing multiple micronutrient powders (MNPs) and iron supplements (syrup/drops) are used to combat anaemia in children in different parts of the world. However, evidence for functional benefits of iron supplementation in children is scarce, and potential risks remain poorly defined, particularly concerning diarrhoea and malaria. This trial aims to determine if: (1) the efficacy of iron supplements or MNPs (containing iron) given with malaria chemoprevention is superior to malaria chemoprevention alone, or (2) if the efficacy of malaria chemoprevention alone is superior to placebo on child cognitive development. METHODS AND ANALYSIS: IRMA is a four-arm, parallel-group, double-blinded, placebo-controlled, triple-dummy, randomised trial in Southern Malawi. The study recruits 2168 infants aged 6 months, with an intervention period of 6 months and a post-intervention period of a further 6 months. Children are randomised into four arms: (1) No intervention (placebo); (2) malaria chemoprevention only; (3) MNPs and malaria chemoprevention; and (4) iron syrup and malaria chemoprevention. The primary outcome, cognitive development (Cognitive Composite Score (CogCS)), is measured at the end of the 6 months intervention. Secondary outcomes include CogCS at a further 6 months post-intervention, motor, language and behavioural development, physical growth and prevalence of anaemia and iron deficiency. Safety outcomes include incidence of malaria and other infections, and prevalence of malaria parasitaemia during and post-intervention period. ETHICS AND DISSEMINATION: The trial is approved by the National Health Sciences Research Committee (#19/01/2213) (Malawi) and the Human Research Ethics Committee (WEHI: 19/012) (Australia). Written informed consent in the local language is obtained from each participant before conducting any study-related procedure. Results will be shared with the local community and internationally with academic and policy stakeholders. TRIAL REGISTRATION NUMBER: ACTRN12620000386932.
-
ItemConsidering equity and cost-effectiveness in assessing a parenting intervention to promote early childhood development in rural Vietnam(OXFORD UNIV PRESS, 2023-09-18)Considering equity in early childhood development (ECD) is important to ensure healthy development for every child. Equity-informative cost-effectiveness analysis can further guide decision makers to maximize outcomes with limited resources while promoting equity. This cost-effectiveness study aimed to examine the equity impacts of a multicomponent ECD intervention in rural Vietnam. We estimated the cost-effectiveness of the intervention with a 30-month time horizon from the service provider and household perspectives with equity considerations. Data were from a cluster-randomized controlled trial comparing the intervention with the local standard of care. The incremental cost-effectiveness ratios (ICERs) per child cognitive development score gained were estimated by household wealth quintile and maternal education level, adjusted for cluster effects and baseline characteristics such as maternal parity and age. A 3% discount rate was applied to costs, and non-parametric cluster bootstrapping was used to examine uncertainty around ICERs. Children in the intervention had higher cognitive development scores than those in the control arm across all subgroups. Based on intervention recurrent cost, the ICER per cognitive development score gained was lower in children from the poorest quintile (-US$6) compared to those from the richest quintile (US$16). Similarly, the ICER per cognitive development score gained was lower in children whose mothers had the lowest education level (-US$0.02) than those with mothers who had the highest education level (US$7). Even though our findings should be interpreted with caution due to the insufficient study power, the findings suggest that the intervention could promote equity while improving child cognitive development with greater cost-effectiveness in disadvantaged groups.
-
ItemPromoting early childhood development in Viet Nam: cost-effectiveness analysis alongside a cluster-randomised trial.(Elsevier BV, 2023-08)BACKGROUND: Economic evaluations are critical to ensure effective resource use to implement and scale up child development interventions. This study aimed to estimate the cost-effectiveness of a multicomponent early childhood development intervention in rural Viet Nam. METHODS: We did a cost-effectiveness study alongside a cluster-randomised trial with a 30-month time horizon. The study included 669 mothers from 42 communes in the intervention group, and 576 mothers from 42 communes in the control group. Mothers in the intervention group attended Learning Clubs sessions from mid-pregnancy to 12 months after delivery. The primary outcomes were child cognitive, language, motor, and social-emotional development at age 2 years. In this analysis, we estimated the incremental cost-effectiveness ratios (ICERs) of the intervention compared with the usual standard of care from the service provider and household perspectives. We used non-parametric bootstrapping to examine uncertainty, and applied a 3% discount rate. FINDINGS: The total intervention cost was US$169 898 (start-up cost $133 692 and recurrent cost $36 206). The recurrent cost per child was $58 (1 341 741 Vietnamese dong). Considering the recurrent cost alone, the base-case ICER was $14 and mean ICER of 1000 bootstrap samples was $14 (95% CI -0·48 to 30) per cognitive development score gained with a 3% discount rate to costs. The ICER per language and motor development score gained was $22 and $20, respectively, with a 3% discount rate to costs. INTERPRETATION: The intervention was cost-effective: the ICER per child cognitive development score gained was 0·5% of Viet Nam's gross domestic product per capita, alongside other benefits in language and motor development. This finding supports the scaling up of this intervention in similar socioeconomic settings. FUNDING: Australian National Health and Medical Research Council and Grand Challenges Canada. TRANSLATION: For the Vietnamese translation of the abstract see Supplementary Materials section.
-
ItemHyperlipidaemia and Weight Amongst Afghani Refugees Attending a General Practice Clinic in Regional Australia(Springer Science and Business Media LLC, 2023-06)Obesity and chronic disease are increasing problems in refugee populations. Afghani refugees undergoing hepatitis B vaccination between January 2015 and December 2017 at a general practice clinic received dietary counselling sessions in Dari by native speaking clinicians. Anthropometry, blood pressure, fasting lipids and liver function tests were measured at both visits with results compared over time. 110/119 refugees requiring hepatitis B vaccination were recruited into the study. Mean BMI was lower at follow up visits (25.4 vs 26.1 by wilcoxon signed rank test p 0.04) with 72 of 110 participants losing a median of 2 kg between visits (range 0.5–14 kg) a mean of 206 days after the initial consultation. Median triglyceride levels were lower at the second visit than the first (1.4 vs 1.3 mmol/L Wilcoxon signed rank test Z = 3.5, p 0.0004). This cohort of refugees lost weight and showed a small improvement in triglyceride levels between visits.
-
Item[Response to] Benefits and Risks of Iron Interventions in Infants in Bangladesh(Massachusetts Medical Society, 2021-12-02)
-
ItemNo Preview AvailableNeglected tropical diseases in Australia: a narrative review(Wiley, 2022-05-12)•Neglected tropical diseases (NTDs) represent a threat to the health, wellbeing and economic prosperity of billions of people worldwide, often causing serious disease or death. •Commonly considered diseases of low and middle-income nations, the presence of NTDs in high income countries such as Australia is often overlooked. •Seven of the 20 recognised NTDs are endemic in Australia: scabies, soil-transmitted helminths and strongyloidiasis, echinococcosis, Buruli ulcer, leprosy, trachoma, and snakebite envenoming. •Dengue, while not currently endemic, poses a risk of establishment in Australia. There are occasional outbreaks of dengue fever, with local transmission, due to introductions in travellers from endemic regions. •Similarly, the risk of introduction of other NTDs from neighbouring countries is a concern. Many NTDs are only seen in Australia in individuals travelling from endemic areas, but they need to be recognised in health settings as the potential consequences of infection can be severe. •In this review, we consider the status of NTDs in Australia, explore the risk of introducing and contracting these infections, and emphasise the negative impact they have on the health of Australians, especially Aboriginal and Torres Strait Islander peoples.
-
ItemNo Preview AvailableIron Supplementation May Selectively Reprofile the Gut Microbiome in Iron-Deficient Bangladeshi Infants(AMER SOC HEMATOLOGY, 2022-11-15)
-
ItemNo Preview AvailableStructured, multicomponent, community-based programme for women?s health and infant health and development in rural Vietnam: a parallel-group cluster randomised controlled trial(ELSEVIER SCI LTD, 2023-05)BACKGROUND: Interventions to improve early childhood development have previously addressed only one or a few risk factors. Learning Clubs is a structured, facilitated, multicomponent programme designed to address eight potentially modifiable risk factors, and offered from mid-pregnancy to 12 months post partum; we aimed to establish whether this programme could improve the cognitive development of children at 2 years of age. METHODS: For this parallel-group cluster-randomised controlled trial, 84 of 116 communes (the clustering unit) in HaNam Province in rural Vietnam were randomly selected and randomly assigned to receive the Learning Clubs intervention (n=42) or usual care (n=42). Women aged at least 18 years who were pregnant (gestational age <20 weeks) were eligible for inclusion. Data sources were standardised, and study-specific questionnaires assessing risks and outcomes were completed in interviews in mid-pregnancy (baseline), late pregnancy (after 32 weeks of gestation), at 6-12 months post partum, and at the end of the study period when children were 2 years of age. Mixed-effects models were used to estimate trial effects, adjusting for clustering. The primary outcome was the cognitive development of children at 2 years of age, assessed by the Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) cognitive score. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000442303). FINDINGS: Between April 28, 2018, and May 30, 2018, 1380 women were screened and 1245 were randomly assigned (669 to the intervention group and 576 to the control group). Data collection was completed on Jan 17, 2021. Data at the end of the study period were contributed by 616 (92%) of 669 women and their children in the intervention group, and by 544 (94%) of 576 women and their children in the control group. Children aged 2 years in the intervention group had significantly higher mean Bayley-III cognitive scores than those in the control group (99·6 [SD 9·7] vs 95·6 [9·4]; mean difference 4·00 [95% CI 2·56-5·43]; p<0·0001). At 2 years of age, 19 (3%) children in the intervention group had Bayley-III scores less than 1 SD, compared with 32 (6%) children in the control group, but this difference was not significant (odds ratio 0·55 [95% CI 0·26-1·17]; p=0·12). There were no significant differences between groups in maternal, fetal, newborn, or child deaths. INTERPRETATION: A facilitated, structured, community-based, multicomponent group programme improved early childhood development to the standardised mean in rural Vietnam and could be implemented in other similarly resource-constrained settings. FUNDING: Australian National Health and Medical Research Council and Grand Challenges Canada Saving Brains Initiative. TRANSLATION: For the Vietnamese translation of the abstract see Supplementary Materials section.
-
ItemThe role of fingernail selenium in the association between arsenic, lead and mercury and child development in rural Vietnam: a cross-sectional analysis(CAMBRIDGE UNIV PRESS, 2023-05-14)As, Pb and Hg are common environmental contaminants in low- and middle-income countries. We investigated the association between child toxicant exposure and growth and development and determined if this association was mitigated by Se concentration. Toxicant concentrations in fingernail samples, anthropometry and Bayley's Scales of Infant Development, 3rd edition domains were assessed in 36-month-old children whose mothers had been part of a randomised controlled trial in rural Vietnam. Multivariable regression analyses were performed to estimate the effect of toxicant exposure on clinical outcomes with adjustments for potential confounders and interaction with fingernail Se concentration. We analysed 658 children who had data for at least one physical or developmental outcome, and at least one toxicant measurement, and each of the covariates. Fingernail As concentration was negatively associated with language (estimate per 10 % increase in As: -0·19, 95 % CI: (-0·32, -0·05)). Pb was negatively associated with cognition (estimate per 10 % increase in Pb: -0·08 (-0·15, -0·02)), language (estimate per 10 % increase in Pb: -0·18 (-0·28, -0·10)) and motor skills (estimate per 10 % increase in Pb: -0·12 (-0·24, 0·00)). Hg was negatively associated with cognition (estimate per 10 % increase in Hg: -0·48, (-0·72, -0·23)) and language (estimate per 10 % increase in Hg -0·51, (-0·88, -0·13)) when Se concentration was set at zero in the model. As Se concentration increased, the negative associations between Hg and both cognition and language scores were attenuated. There was no association between toxicant concentration and growth. As, Pb and Hg concentrations in fingernails of 3-year-old children were associated with lower child development scores. The negative association between Hg and neurological development was reduced in magnitude with increasing Se concentration. Se status should be considered when assessing heavy metal toxicants in children and their impact on neurodevelopmental outcomes.
-
ItemEffects of iron supplementation on neural indices of habituation in Bangladeshi children(ELSEVIER SCIENCE INC, 2023-01)BACKGROUND: Iron deficiency and anemia have been associated with poor cognition in children, yet the effects of iron supplementation on neurocognition remain unclear. OBJECTIVE: We aimed to examine the effects of supplementation with iron on neural indices of habituation using auditory event-related brain potentials (ERPs). METHODS: This substudy was nested within a 3-arm, double-blind, double-dummy, individual randomized trial in Bangladesh, in which 3300 8-mo-old children were randomly selected to receive 3 mo of daily iron syrup (12.5 mg iron), multiple micronutrient powders (MNPs) (including 12.5 mg iron), or placebo. Children were assessed after 3 mo of intervention (mo 3) and 9 mo thereafter (mo 12). The neurocognitive substudy comprised a randomly selected subset of children from the main trial. Brain activity elicited during an auditory roving oddball task was recorded using electroencephalography to provide an index of habituation. The differential response to a novel (deviant) compared with a repeated (standard) sound was examined. The primary outcome was the amplitude of the mismatch response (deviant minusstandard tone waveforms) at mo 3. Secondary outcomes included the deviant and standard tone-evoked amplitudes, N2 amplitude differences, and differences in mean amplitudes evoked by deviant tones presented in the second compared with first half of the oddball sequence at mo 3 and 12. RESULTS: Data were analyzed from 329 children at month 3 and 363 at mo 12. Analyses indicated no treatment effects of iron interventions compared with placebo on the amplitude of the mismatch response (iron syrup compared with placebo: mean difference (MD) = 0.07μV [95% CI: -1.22, 1.37]; MNPs compared with placebo: MD = 0.58μV [95% CI: -0.74, 1.90]) nor any secondary ERP outcomes at mo 3 or 12, despite improvements in hemoglobin and ferritin concentrations from iron syrup and MNPs in this nested substudy. CONCLUSION: In Bangladeshi children with >40% anemia prevalence, iron or MNP interventions alone are insufficient to improve neural indices of habituation. This trial was registered at the Australian New Zealand Clinical Trials Registry as ACTRN12617000660381.