Methods | RCT Length of follow‐up: 5 years |
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Participants | All children living in endemic area Number analysed for primary outcome: 1423 Mean age: 15 months (randomized at 1.5 years) Inclusion criteria: 15 month old children whose mothers participated in the pregnancy phase of the trial (pregnant healthy women from the area, planning to deliver at Entebbe Hospital) Exclusion criteria: none stated |
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Interventions | Multiple dose vs placebo Factorial designa
aMothers when pregnant had been randomized in a 1:1:1:1 ratio to receive single‐dose albendazole (400 mg) + praziquantel (40 mcg/kg), albendazole + praziquantel placebo, albendazole placebo + praziquantel, or albendazole placebo + praziquantel placebo. |
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Outcomes |
Not included in review: immune response at age 5 years to BCG and tetanus immunisation, incidence of malaria, diarrhoea, pneumonia, measles, and tuberculosis, measures of fine motor function and gross motor function. |
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Notes | Location: Entebbe, Uganda Community category: 3 Source of funding: Wellcome Trust |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization code generated by statistician using Stata version 7. |
Allocation concealment (selection bias) | Unclear risk | No details reported. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants and provider blinded. Not reported for assessors. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Inclusion of all randomized participants (number evaluable/number randomized): 71% (1423/2016) of randomized participants. |
Selective reporting (reporting bias) | High risk | Serious adverse events not reported. |
Other bias | Low risk | No other obvious source of bias. |