Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004705649428 Date of Approval: 01/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 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 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
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard Care Anticipated duration on study for women recruited at 34 weeks gestation and followed up to 12 weeks postnatally is 18 weeks, however duration may be up to a maximum of 20 weeks. Women will receive standard antenatal care and Maama kit plus routine antenatal education and will be advised to continue with their usual hand hygiene practices 2966 Active-Treatment of Control Group
Experimental Group ABHR Product Women recruited from 34 weeks gestation and followed up to 12 weeks postnatal will be in the study for 18 weeks but up to a maximum of 20 weeks. Women in the intervention group will receive a Maama kit containing BabyGel ABHR kit (5 litre jerry can, 1 litre bottle and 60ml bottle) and will trained in hand hygiene based on the '3 moments of community neonatal hand hygiene' i.e. 1) before touching baby, 2) after changing diapers and 3) after known risk exposure such as using the toilet or touching soiled surfaces 2966
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Participant is willing and able to give informed consent for participation in the study. • Female, aged 18 years or above, or those under 18 so long as emancipated. • At least 34 weeks pregnant • Living in one of the villages in the Mbale or Budaka Districts defined within this study protocol, and planning to be living in that same village for the first 3 months after birth • Women who are pregnant and not living in one of the villages specified in this protocol. • Women who have previously participated in the BabyGel study and present with a further pregnancy Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/01/2020 CURE Childrens Hospital of Uganda REC
Ethics Committee Address
Street address City Postal code Country
Plot 97-105 Bugwere Road, PO Box 903, Mbale, Uganda Mbale 999999 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/02/2020 University of Liverpool REC
Ethics Committee Address
Street address City Postal code Country
Waterhouse Buildings, 3 Brownlow Street Liverpool L69 3GL United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/11/2019 Regionale komiteer for medisinsk og helsefaglig forskningsetikk REK vest
Ethics Committee Address
Street address City Postal code Country
Armauer Hansens Hus, Nordre velvet, 2nd floor, Haukelandsveien 28 Bergen 5020 Norway
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be death or severe infant illness in the first 90 days of life. Severe illness = an illness that is associated with any of the following danger signs observed or verified by a study clinician: inability to feed or vomiting of all intake, lethargy or unconsciousness, severe lower chest in-drawing, axillary temperature of ≥37.5 °C or <35.5 °C, grunting, cyanosis, convulsions or a history of convulsions, and/or results in hospitalization and/or results in death). 3 months
Secondary Outcome The main secondary outcomes are infant diarrhoea and lower respiratory tract infections from maternal reports. Other secondary outcomes include - Rates of omphalitis (photographed and expert-defined), Infant sepsis, meningitis, skin infections, tetanus, clinical jaundice, oedema, dehydration and neglected diseases (echinococcosise, foodborne trematodiases, leprosy, trachoma, yaws; all clinician verified). Mean differences in –z-scores according to the WHO growth standards at 3 months will compare effect of ABHR on linear and ponderal growth of the infant during the first 3 months of life. Economic outcomes for each participating family will also compared. 3 months
Secondary Outcome Outcomes related to the mother include - Antibiotic use, hand gel use, frequency of other hand washing episodes, substance use on cord, feeding practices, satisfaction. Numbers of women with sepsis related to recent delivery of an infant (maternal report, up to 3 months postnatally) 3 months
Secondary Outcome Exploratory outcomes include participants wealth quintile based on possessions to explore the relationship between health inequalities and rates of maternal and infant morbidity. Interviews with participants and surveys of study villages will explore current hand hygiene practices and options of improving practice in rural Ugandan villages. 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sanyu Africa Research Institute SAfRI Mbale Regional Refferal Hospital within HMDC Complex, Off Palisa-Kumi Road Junction, PO Box 2190 Mbale Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
The EDCTP Association PO Box 93015, 2509 AA The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Liverpool Research Support Office, Block D Waterhouse Building, 3 Brownlow Street, Liverpool, L69 3GL Liverpool L69 3GL United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
University of Liverpool The Foundation Building, 765 Brownlow Hill Liverpool L69 3BX United Kingdom
Liverpool School of Tropical Medicine Pembroke Place Liverpool L3 5QA United Kingdom
Universitetet i Bergen Museplass 1, PO 7800 Bergen N-5020 Norway
Busitema University 226 Busia, Tororo, Uganda Tororo Uganda
University of Exeter Northcote House, The Queens Drive Exeter EX4 4QJ United Kingdom
Makerere University PO Box 7062, Kampala Kampala Uganda
Ministry of Health Uganda PO Box 7272, Kampala, Plot 6, Lourdel Road, Nakasero Kampala Uganda
Mbale Regional Referral Hospital Plot 29-33, PO Box 921, Mbale Mbale Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Martin Chebet martinchebet@yahoo.co.uk +256393280580 Off Kumi-Pallisa Road Junction P.O BOX 2190
City Postal code Country Position/Affiliation
Mbale Uganda Principal Investigator
Role Name Email Phone Street address
Public Enquiries David Mukunya zebdaevid@gmail.com +256393280580 Off Kumi-Pallisa Road Junction P.O BOX 2190
City Postal code Country Position/Affiliation
Mbale Uganda Trial Manager
Role Name Email Phone Street address
Scientific Enquiries Andrew Weeks aweeks@liverpool.ac.uk +441517959578 SANYU, Dept. of Women and Children Health, Liverpool Womens Hospital, Crown Street
City Postal code Country Position/Affiliation
Liverpool United Kingdom Chief Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The research database will be made publicly available once the study findings have been published in a suitable repository such as Dryad. A document summarising the methods used to generate the data with a full description of all procedures, analyses, data capture tools, coding and description of variables will be published alongside the research database. Analytic Code,Statistical Analysis Plan,Study Protocol The research database will be made publicly available following the publication of study findings in 2024. Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.sanyuresearch.org/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information