Project: A cluster randomised trial to evaluate the effectiveness of household alcohol-based handrub for the prevention of sepsis, diarrhoea and pneumonia in Ugandan infants.

Acronym BabyGel (Reference Number: RIA2017MC-2029)
Duration 01/02/2019 - 31/01/2024
Project Topic 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. Women will be eligible if they are over 34 weeks pregnant (estimated by menstrual or ultrasound scan dates) and reside in the participating villages. The only exclusion criterion will be women who are unable or unwilling to participate throughout the study period. The intervention is an alcohol-based handrub (ABHR) with added floral perfume and bitterant, to be used by mothers and any other baby carers for the first 3 months postnatally in addition to their normal hand washing. Women in the intervention villages at the time of recruitment will receive a Maama birthing kit, a BabyGel kit containing a 5-Litre ABHR along with 2 dispensers, and the ‘3 Moments of community neonatal hand hygiene’ poster developed during the BabyGel pilot study. The 3 Moments include: (i) before touching the baby, (ii) for initial cord care, and (iii) after known risk exposure (using the toilet, after touching soiled items or surfaces). Women in the control clusters will receive the standard recommended care of Maama birthing kit, be monitored and followed up in the same way as those in the intervention clusters. Mothers in both arms will also receive routine antenatal education, which includes information on postnatal newborn care, hand hygiene, and nutrition and facility postnatal checks. The primary outcome will be severe infant illness or death in the first 90 days of life. Main secondary outcomes are diarrhoea and infant lower respiratory tract infections. Further analyses will specifically address the rate of omphalitis and health economic outcomes (including an examination of the effect of health inequalities). The project includes studentships for 3 Ugandan PhD students, a Ugandan research fellow and 3 MMed students (within the new Busitema postgraduate training programme).
Network EDCTP2
Call Clinical trials and operational research studies to optimise the use of products for poverty-related diseases in mothers, newborns, children and/or adolescents

Project partner

Number Name Role Country
1 University of Liverpool Coordinator United Kingdom
4 Busitema University Partner Uganda
5 Liverpool School of Tropical Medicine Partner United Kingdom
8 Makerere University Partner Uganda
9 Mbale Regional Referral Hospital Partner Uganda
11 Ministry of Health - Uganda Partner Uganda
12 Sanyu Africa Research Institute Partner Uganda
15 University of Bergen Partner Norway
17 University of Exeter Partner United Kingdom