Status:
COMPLETED
The Safe Start Trial - Kisumu, Kenya
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Great Lakes University Kisumu
University of Iowa
Conditions:
Enteric Infections
Diarrhea
Eligibility:
All Genders
21-23 years
Phase:
NA
Brief Summary
This a cluster randomised controlled trial (cRCT) to evaluate the effect of a novel food hygiene intervention on infant health.
Detailed Description
Enteric infections remain a major threat to child health and development in many low and middle-income countries. Globally, diarrhoeal disease - a key health consequence of enteric infection - is rank...
Eligibility Criteria
Inclusion
- Infant is 21-23 weeks of age at enrolment
- Infant's mother residing within catchment of participating health extension worker at time of enrolment and intends to stay in current dwelling at least until infant reaches 37 weeks of age
Exclusion
- Infant with any medical, psychiatric or social condition which, in the opinion of the research team, impedes the participant's ability to give informed consent
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2019
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT03468114
Start Date
March 26 2018
End Date
June 22 2019
Last Update
August 21 2019
Active Locations (1)
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1
Great Lakes University Kisumu
Kisumu, Kenya