Condition category
Infections and Infestations
Date applied
02/03/2015
Date assigned
18/03/2015
Last edited
18/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There are an estimated 3 million neonatal deaths every year across the world. In Uganda, with over 1.5 million live births annually, 142,000 infants die every year before the age of five with 33% of these dying during the neonatal period (within the first 28 days of life). This places Uganda 153rd out of 163 countries in the global rank for frequency of neonatal deaths. Most newborn infections and deaths occur in the community, and are often not reported to the health sector. For example, preliminary findings from the Iganga/Mayuge Demographic Surveillance Site showed that 60% of all deaths occur outside a health facility setting and go unreported. Local community studies suggest an infection rate of around 30%. In terms of infection prevention, hand washing with soap even when washed with unclean water results in a large reduction in hand contamination. A recent systematic review concluded that there was a lack quality evidence for the effect of clean birth and postnatal newborn care practices on the number of neonatal deaths. However, the need for clean birth and postnatal care is widely accepted. A Delphi expert consensus process judged that clean birth practices at home with no skilled attendant could reduce neonatal sepsis deaths by 15% and tetanus deaths by 30%. The panel judged that improved postnatal newborn care practices could prevent 40% of neonatal sepsis deaths, but that more research is needed particularly on the content and quality of care during the early postnatal period. This research project seeks to determine whether the provision of alcohol hand gel to postnatal women in rural Uganda is a clinically and cost effective way of preventing early infant infections. The handgel comparison study is designed by WHO and the project questionnaires are published on the WHO website as part of the WHO ‘Clean Care is Safer Care’ campaign. The main research question is: does the addition of bitterants and perfume affect the acceptability of alcohol-based handgel? However, secondary research questions will be:
1. To determine the frequency of use of the product (and hence the volume used)
2. Does the addition of bitterants and perfume affect the tolerability of alcohol-based handgel?
3. Is the frequency of use related to its acceptability?
4. To determine the frequency of handrub use amongst postnatal women
5. To determine women’s preference for size of handrub container, and whether this is related to frequency of travel out of their compound.

Who can participate?
Postnatal women with children aged under 3 months of age living in one of the villages participating in the study.

What does the study involve?
Participants are randomly allocated (according to which village they live) to receive one of 3 different alcohol handrubs in a predetermined order. Each participant uses the allocated handrub for 5 consecutive days followed by a 2-day ‘washout’ period in which they will not use any handrub. At the end of each week they are asked to return to the health centre to complete evaluation forms and to receive the next pack of handrub. Those who do not attend the follow-up are contacted by telephone and alternative way of follow-up with the research staff arranged (on an alternative day and / or an alternative, more convenient place).
The following alcohol handrub formulations are compared:
1. Plain alcohol handrub containing ethanol 80% (Alsoft V, Saraya East Africa Ltd).
2. Alsoft V with added bitterant: bitterant is normally added to prevent alcoholic abuse of the gel, but this may interfere with acceptability in women who normally eat meals with their hands
3. Alsoft V with an added floral perfume: The standard Saraya health care hand gel is unperfumed, but in the feasibility study women particularly liked a previous perfumed formulation that we used.
Participants are asked to use the handrub according to the WHO ‘4 moments for hand hygiene’ in non-hospital settings. The data collection form is based on that produced by WHO and will be analysed using the WHO analysis tool.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Ten rural villages in Mbale district (Uganda)

When is the study starting and how long is it expected to run for?
March 2015 to February 2016

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Professor Andrew Weeks
aweeks@liv.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Professor Andrew Weeks

ORCID ID

Contact details

Sanyu Research Unit
Department of Women's and Children's Health
University of Liverpool
1st Floor
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
01517959578
aweeks@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.9

Study information

Scientific title

BabyGel Pilot: a pilot study of a cluster randomised trial of the provision of alcohol handgel to postpartum mothers in Mbale, Eastern Uganda to prevent neonatal infective morbidity in the home.

Acronym

Babygel

Study hypothesis

To test the feasibility of conducting the main cluster randomised trial of the provision of alcohol handgel to postpartum mothers in prevention of neonatal infective morbidity in the community

Ethics approval

1. University of Liverpool Ethics Committee
2. Mbale Regional Hospital Institutional Review Committee (MRHIRC)

Study design

An open, 2-arm cluster randomised trial with rural villages as the unit of randomisation in Eastern Uganda.

Primary study design

Observational

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please email safri@liv.ac.uk to request a patient information sheet

Condition

Reduction in infant (>3 months) sepsis thereby leading to a possible reduction in infant morbidity and mortality

Intervention

A pilot study of a cluster randomised trial of the provision of alcohol handgel to postpartum mothers to prevent neonatal infective morbidity in the home.
This pilot study (work stream 1) will be used to formally pilot the planned main open, 2-arm cluster randomised controlled trial (RCT) comparing alcohol hand rub with normal care. This pilot is one of 3 studies being conducted in preparation for the main BabyGel cluster RCT, and will take place in 10 villages around Mbale, Uganda. Workstream 1 will assess the feasibility of conducting the main trial. Other workstreams are evaluating the optimal hand rub formulation (workstream 2) and consent procedures (workstream 3).

The study will be a 3-way, blinded, randomised cross-over study. Forty postnatal women with children aged under 3 months of age will be recruited through the infant vaccination clinics in two local health centres. The only exclusion will be of those who currently use antiseptic hand wash at home and wish to continue its use. The study will be explained to the women at the clinic and they will be given or read a participant information sheet, which will be translated into the local languages. Those who wish to participate will be asked to provide signed consent.

Participants will be randomly allocated to receive one of 3 different alcohol handrubs in a predetermined order. Each participant will use the allocated handrub for 5 consecutive days followed by a 2-day ‘washout’ period in which they will not use any handrub. At the end of each week they will be asked to return to the health centre to complete evaluation forms and to receive the next pack of handrub. Those who do not attend the follow-up will be contacted by telephone and alternative way of follow-up with the research staff arranged (on an alternative day and / or a alternative, more convenient place).

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Infant sepsis (using the Young Infant Clinical Signs Study Group (YICSSG) criteria
2. Sepsis death in the first 90 days of life (assessed using verbal autopsy)

Secondary outcome measures

Neonatal: Physician diagnosed infant infection, Microbiologically confirmed infant infection rate in the first 90 days of life (blood culture and cerebrospinal fluid), Infant mortality at 24hrs, 7 days, 4 weeks, and 3 months of life, Individual infant infections, General: fever, clinical jaundice, Infant weight and height at 3 months
Maternal: Gel Hand hygiene compliance, frequency of other hand washing; Maternal postnatal pelvic infection, other infections and satisfaction.

Overall trial start date

01/03/2015

Overall trial end date

28/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with an estimated gestation of over 34 weeks
2. Reside in the participating villages.

The gestation age will be determined by the Last Normal Menstruation period (LNMP), and or Ultra sound scan.

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

Women will be excluded from the study if they
1. Are temporary resident (visitors) in one of the Mbale villages
2. Plan to relocate to distant places (outside of the Mbale District) within 3 months of childbirth

Recruitment start date

01/04/2015

Recruitment end date

01/06/2015

Locations

Countries of recruitment

Uganda

Trial participating centre

Buwangolo Village
Mbale District of Eastern Uganda
Mbale
Uganda

Trial participating centre

Bulusambu Village
Mbale District of Eastern Uganda
Mbale
Uruguay

Trial participating centre

Namwaro
Mbale District of Eastern Uganda
Mbale
Uganda

Trial participating centre

Namunyu
Mbale District of Eastern Uganda
Mbale
Uganda

Trial participating centre

Bufukhula Central
Mbale District of Eastern Uganda
Mbale
Uganda

Trial participating centre

Buwalasitoma
Mbale District of Eastern Uganda
Mbale
Uganda

Trial participating centre

Makhonje Village
Mbale District of Eastern Uganda
Mbale
Uganda

Trial participating centre

Namakye Village
Mbale District of Eastern Uganda
Mbale
Uganda

Trial participating centre

Bunanimi Village
Mbale District of Eastern Uganda
Mbale
Uganda

Trial participating centre

Bumulaa Toma Village
Mbale District of Eastern Uganda
Mbale
Uganda

Sponsor information

Organisation

University of Liverpool

Sponsor details

Liverpool Health Partners
Joint Research Office
Waterhouse Buildings
2nd Floor Block D Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
0151 794 8373
sponsor@liv.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes