Study Title
A cluster randomised trial to evaluate the effectiveness of household alcohol-based handrub for the prevention of sepsis, diarrhoea and pneumonia in Ugandan infants
Link to the Pilot trial at http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN67852437
Study Design
2-arm cluster randomised trial with rural villages as units of randomisation.
Study Participants
Women who have reached 34 weeks of gestation and their babies (once born) living in villages in Mbale District, Eastern Uganda.
Sample Size: 5932 women
Planned Study Period
This study is funded for a period of 60 months commencing 1st February 2019 – 31st January 2024.
Planned Recruitment period
The recruitment period is planned for 26 months with a projected commencement date of the beginning of April 2010.
Objectives
Primary
The principal objective of this study is to determine whether the provision of alcohol-based hand rub (ABHR) to pregnant women for postnatal household use is effective for the prevention of severe illness or death during the first 3 months of life. Over 60 months, an open, 2-arm cluster randomised trial with rural villages as units of randomisation will be conducted in which pregnant women will be recruited from homes within 72 study villages in Mbale region, Eastern Uganda.
Primary
The principal objective of this study is to determine whether the provision of alcohol-based hand rub (ABHR) to pregnant women for postnatal household use is effective for the prevention of severe illness or death during the first 3 months of life. Over 60 months, an open, 2-arm cluster randomised trial with rural villages as units of randomisation will be conducted in which pregnant women will be recruited from homes within 72 study villages in Mbale region, Eastern Uganda.
Secondary
- To determine the impact of ABHR use by the carer on clinical omphalitis.
- To determine the cost and cost-effectiveness of providing ABHR to pregnant women in rural Eastern Uganda as a way of preventing early childhood severe illness and death in the first 3 months of life.
- To assess health inequities in participants by comparing the study outcomes in each wealth quintile.
- To investigate the microbiological sources of infection in a rural Ugandan community during early infant life.
- To explore current hand hygiene practices and options of improving practice in rural Ugandan villages
Primary
The primary outcome will be severe infant illness or death in the first 90 days of life.
Secondary
Main secondary outcomes are diarrhoea and infant lower respiratory tract infections. Further analyses will specifically address early growth (including linear and ponderal growth) and health economic outcomes (including an examination of the effect of health inequalities).
Primary
Women will be recruited to the study at 34 weeks of gestation (determined by menstrual dates or ultrasound). At this point women will either be issued with a Maama kit (which includes the ABHR) or a Maama kit without the ABHR. This will be dependent on how the village in which they live has been randomised.
Women will be visited by the Village Health Worker once their baby has been born
Secondary
Women will be contacted regularly during the first 3 months postnatally and will also have access to the research team to report any illness in the participants.
Intervention(s)
ABHR which will be included in the Maama Kits issued by the research team to women in the villages randomised to receive the intervention. The women will be asked to use the ABHR alongside their normal hand washing practices.
Comparator
No use of ABHR. Women in the comparator villages will not receive the ABHR alongside their Maama kits but will be asked to continue their hand washing practices.
Funder
“This project is part of the EDCTP2 Programme supported by the European Union.”
Sponsor
Collaborating Institutions
