12 research outputs found
Impact of Anthelminthic Treatment in Pregnancy and Childhood on Immunisations, Infections and Eczema in Childhood:A Randomised Controlled Trial
Helminth infections may modulate immune responses to unrelated pathogens and allergens; these effects may commence prenatally. We addressed the hypothesis that anthelminthic treatment in pregnancy and early childhood would improve responses to immunisation and modulate disease incidence in early childhood with both beneficial and detrimental effects.A randomised, double-blind, placebo-controlled trial was conducted in Entebbe, Uganda [ISRCTN32849447]. In three independent randomisations, 2507 pregnant women were allocated to receive single-dose albendazole or placebo, and praziquantel or placebo; 2016 of their offspring were randomised to receive quarterly single-dose albendazole or placebo from age 15 months to 5 years. Primary outcomes were post-immunisation recall responses to BCG and tetanus antigens, and incidence of malaria, diarrhoea, and pneumonia; incidence of eczema was an important secondary outcome. Analysis was by intention-to-treat. Of 2345 live births, 1622 (69%) children remained in follow-up at age 5 years. 68% of mothers at enrolment, and 11% of five-year-olds, had helminth infections. Maternal hookworm and Schistosoma mansoni were effectively treated by albendazole and praziquantel, respectively; and childhood hookworm and Ascaris by quarterly albendazole. Incidence rates of malaria, diarrhoea, pneumonia, and eczema were 34, 65, 10 and 5 per 100 py, respectively. Albendazole during pregnancy caused an increased rate of eczema in the children (HR 1.58 (95% CI 1.15–2.17), p = 0.005). Quarterly albendazole during childhood was associated with reduced incidence of clinical malaria (HR 0.85 (95% CI 0.73–0.98), p = 0.03). There were no consistent effects of the interventions on any other outcome.Routine use of albendazole in pregnancy may not always be beneficial, even in tropical developing countries. By contrast, regular albendazole treatment in preschool children may have an additional benefit for malaria control where helminths and malaria are co-endemic. Given the low helminth prevalence in our children, the effect of albendazole on malaria is likely to be direct.Current Controlled Trials ISRCTN3284944
The effect of maternal anthelminthic treatment on childhood disease incidence by maternal helminth status (from birth to 5 years).
<p>The effect of maternal anthelminthic treatment on childhood disease incidence by maternal helminth status (from birth to 5 years).</p
Effect of quarterly albendazole from age 15 months to 5 years on infectious disease incidence in children.
<p>Kaplan-Meier survival estimates for time to first (or only episode) of (a) malaria, (b) diarrhoea and (c) pneumonia during the intervention period, comparing children who received quarterly albendazole with those who received placebo. Numbers shown in the tables are number of events (in brackets) and number of children at risk.</p
The effect of anthelminthic treatment during pregnancy on incidence of malaria, diarrhoea, pneumonia and eczema during early childhood (from birth to 5 years).
<p>There was no evidence of interaction between maternal albendazole and praziquantel treatments, therefore the effects of each treatment were examined independently.</p
The effect of quarterly albendazole during childhood on the recall response to mycobacterial and tetanus antigens, and on anti-tetanus antibody levels, at age 5 years.
<p>cCFP: crude culture filtrate proteins of <i>Mycobacterium tuberculosis</i>.</p>a<p>geometric mean of response concentration +1;</p>b<p>bias-corrected accelerated confidence intervals computed by bootstrapping.</p
The prevalence of helminth infection at each routine annual visit, by childhood treatment group.
1<p>For each annual visit, denominators are slightly lower than in Web <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0050325#pone-0050325-t003" target="_blank">Table 3</a> due to excluding children who were first randomised at that annual visit.</p
The effect of quarterly albendazole during childhood on incidence of malaria, diarrhoea, pneumonia, and eczema (15 months to 5 years).
*<p>Hazard Ratio adjusted for eczema prior to randomisation and maternal hookworm at enrolment.</p
The effect of quarterly albendazole during childhood on asymptomatic malaria parasitaemia, haemoglobin and growth.
<p>Malaria parasitaemia results were missing for 39, 53, 52 and 38 children at ages 2, 3, 4 and 5 years, respectively; haemoglobin results were missing for 17, 28, 658<sup>b</sup> and 13 children at ages 2, 3, 4 and 5 years, respectively; weight-for-age z-scores were missing for 2, 0, 1 and 4 children at ages 2, 3, 4 and 5 years, respectively; height-for-age z-scores were missing for 12, 2, 9 and 12 children at ages 2, 3, 4 and 5 years, respectively; weight-for-height z-scores were missing for 16, 4, 11 and 184<sup>c</sup> children at ages 2, 3, 4 and 5 years, respectively.</p>a<p>The effect of quarterly albendazole on asymptomatic malaria parasitaemia changed with time (interaction p = 0.02), therefore the overall effect of the intervention on this outcome is not presented.</p>b<p>Haemoglobin was not measured for four-year olds from 22<sup>nd</sup> January 2009 onwards due to budget constraints.</p>c<p>Weight-for-height z-scores could not be calculated using WHO Anthro software for children who were aged >5 years and 1 month.</p
Characteristics of children enrolled in the trial of quarterly albendazole versus placebo from age 15 months to five years, at the time of randomisation.
a<p>The number of mothers with children randomised is lower than the number of children randomised due to 20 sets of twins;</p>b<p>mv: missing values;</p
Flow of participants through the childhood trial.
<p>Flow of participants through the childhood trial.</p