Trial no.:
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PACTR202004705649428 |
Date of Approval:
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01/04/2020 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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BabyGel Trial |
Official scientific 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 |
Brief summary describing the background
and objectives of the trial
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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 within the 3 district clusters of Busiu, Budaka and Kolonyi. The intervention is an alcohol-based handrub (ABHR) with added floral perfume and bitterant, to be used antenatally by mothers from 34 weeks, and 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 with chlorhexidine gel, 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) after changing a diaper/nappy, and (iii) after known risk exposure (using the toilet, after touching soiled items or surfaces). Training in hand hygiene will be conducted a minimum of 4 times starting antenatally – at recruitment and 2 weeks later in person, then followed up at least twice by telephone – and once postnatally. Women in the control clusters will receive the standard recommended care of Maama birthing kit with Chlorhexidine, 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. The main secondary outcomes are infant diarrhoea and lower respiratory tract infections. Further analyses will specifically address newborn growth, the rate of omphalitis and health economic outcomes (including an examination of the effect of health inequalities). |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
BabyGel |
Disease(s) or condition(s) being studied |
Infections and Infestations,Neonatal Diseases,Paediatrics,Pregnancy and Childbirth |
Sub-Disease(s) or condition(s) being studied |
sepsis, diarrhoea and pneumonia |
Purpose of the trial |
Prevention |
Anticipated trial start date |
04/05/2020 |
Actual trial start date |
11/01/2021 |
Anticipated date of last follow up |
31/12/2023 |
Actual Last follow-up date |
20/04/2024 |
Anticipated target sample size (number of participants) |
5932 |
Actual target sample size (number of participants) |
6102 |
Recruitment status |
Completed |
Publication URL |
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