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. 2015 Jul 23;2015(7):CD000371. doi: 10.1002/14651858.CD000371.pub6
Methods RCT
Length of follow‐up: 5 years
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
Interventions Multiple dose vs placebo
Factorial designa
  1. Albendazole: 200 mg quarterly from age 15 to 21 months; 400 mg quarterly from age 2 to 5 years;

  2. Matching placebo.


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.
Outcomes
  1. Weight‐for‐age z‐score;

  2. Height‐for‐age z‐score;

  3. Weight‐for‐height z‐score;

  4. Haemoglobin;

  5. Cognitive tests including Block design, Picture vocabulary scale, Sentence repetition, Verbal fluency, Counting span, Running memory, Picture search, Wisconsin card sort test, Tap once tap twice task, Shapes task, Tower of London;

  6. Serious adverse events;

  7. Death.


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.
Notes Location: Entebbe, Uganda
Community category: 3
Source of funding: Wellcome Trust
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.