Introduction: Pneumonia and diarrhoea are leading causes of death in children. There is a need
to develop effective interventions.
Objective: We present the design and baseline findings of a community-randomised controlled
trial in rural Peru to evaluate the health impact of an Integrated Home-based Intervention
Package in children aged 6 to 35 months.
Methods: We randomised 51 communities. The intervention was developed through a
community-participatory approach prior to the trial. They comprised the construction of
improved stoves and kitchen sinks, the promotion of hand washing, and solar drinking water
disinfection (SODIS). To reduce the potential impact of non-blinding bias, a psychomotor
stimulation intervention was implemented in the control arm. The baseline survey included
anthropometric and socio-economic characteristics. In a sub-sample we determined the level
of faecal contamination of drinking water, hands and kitchen utensils and the prevalence of
diarrhoegenic Escherichia coli in stool specimen.
Results: We enrolled 534 children. At baseline all households used open fires and 77% had
access to piped water supplies. E. coli was found in drinking water in 68% and 64% of the
intervention and control households. Diarrhoegenic E. coli strains were isolated from 45/139
stool samples. The proportion of stunted children was 54%.
Conclusions: Randomization resulted in comparable study arms. Recently, several critical
reviews raised major concerns on the reliability of open health intervention trials, because of
uncertain sustainability and non-blinding bias. In this regard, the presented trial featuring
objective outcome measures, a simultaneous intervention in the control communities and a 12-
month follow up period will provide valuable evidence.
Authors: Hartinger, S.M.; Lanata, Claudio F.; Hattendorf, J.; Gil, I.; Verastegui, H.; Ochoa, T.; Mäusezahl, D.
Source: Contemporary Clinical Trials
URL: http://hdl.handle.net/10757/347070
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