A cluster randomised trial to evaluate the effectiveness of household alcohol-based hand rub for the prevention of sepsis, diarrhoea, and pneumonia in Ugandan infants (the BabyGel trial): a study protocol

Martin Chebet; David Mukunya; Kathy Burgoine; Melf Jakob Kühl; Duolao Wang; Antonieta Medina-Lara; Eric Brian Faragher; Amos Odiit; Peter Olupot-Olupot; Ingunn Marie Stadskleiv Engebretsen; John Baptist Waniaye; Julius Wandabwa; Thorkild Tylleskär; Andrew Weeks

doi:10.1186/s13063-023-07312-1

A cluster randomised trial to evaluate the effectiveness of household alcohol-based hand rub for the prevention of sepsis, diarrhoea, and pneumonia in Ugandan infants (the BabyGel trial): a study protocol

Martin Chebet
, David Mukunya
, Kathy Burgoine
, Melf Jakob Kühl
, Duolao Wang
, Antonieta Medina-Lara
, Eric Brian Faragher
, Amos Odiit
, Peter Olupot-Olupot
, Ingunn Marie Stadskleiv Engebretsen
, John Baptist Waniaye
, Julius Wandabwa
, Thorkild Tylleskär
, Andrew Weeks

Clinical Sciences

Busitema University
University of Bergen
Sanyu Africa Research Institute
Mbale Regional Referral Hospital
University of Exeter
Liverpool School of Tropical Medicine
Ngora Freda Carr Hospital
Mbale Clinical Research Institute
Uganda Ministry of Health
University of Liverpool

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

Abstract

Background:

Infections are one of the leading causes of death in the neonatal period. This trial aims to evaluate if the provision of alcohol-based hand rub (ABHR) to pregnant women for postnatal household use prevents severe infections (including sepsis, diarrhoea, pneumonia, or death) among infants during the first three postnatal months.

Methods:

Through a cluster-randomised trial in eastern Uganda, 72 clusters are randomised in a 2-arm design with rural villages as units of randomisation. We estimate to include a total of 5932 pregnant women at 34 weeks of gestation. All women and infants in the study are receiving standard antenatal and postnatal care. Women in the intervention group additionally receive six litres of ABHR and training on its use. Research midwives conduct follow-up visits at participants’ homes on days 1, 7, 28, 42, and 90 after birth and telephone calls on days 14, 48, and 60 to assess the mother and infant for study outcomes. Primary analyses will be by intention to treat.

Discussion:

This study will provide evidence on the effectiveness of a locally available and low-cost intervention in preventing neonatal sepsis and early infant infections. If ABHR is found effective, it could be implemented by adding it to birthing kits.

Trial registration:

Pan African Clinical Trial Registry, PACTR202004705649428. Registered 1 April 2020, https://pactr.samrc.ac.za/.

Original language	English
Article number	279
Pages (from-to)	e279
Journal	Trials
Volume	24
Issue number	1
Early online date	17 Apr 2023
DOIs	https://doi.org/10.1186/s13063-023-07312-1
Publication status	Published - 17 Apr 2023

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Alcohol-based hand rub
Infections
Neonatal
Newborn
Sepsis
Uganda

Access to Document

10.1186/s13063-023-07312-1Licence: CC BY

13063 2023 Article 7312Final published version, 966 KBLicence: CC BY

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Chebet, M., Mukunya, D., Burgoine, K., Kühl, M. J., Wang, D., Medina-Lara, A., Faragher, E. B., Odiit, A., Olupot-Olupot, P., Stadskleiv Engebretsen, I. M., Waniaye, J. B., Wandabwa, J., Tylleskär, T., & Weeks, A. (2023). A cluster randomised trial to evaluate the effectiveness of household alcohol-based hand rub for the prevention of sepsis, diarrhoea, and pneumonia in Ugandan infants (the BabyGel trial): a study protocol. Trials, 24(1), e279. Article 279. https://doi.org/10.1186/s13063-023-07312-1

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title = "A cluster randomised trial to evaluate the effectiveness of household alcohol-based hand rub for the prevention of sepsis, diarrhoea, and pneumonia in Ugandan infants (the BabyGel trial): a study protocol",

abstract = "Background:Infections are one of the leading causes of death in the neonatal period. This trial aims to evaluate if the provision of alcohol-based hand rub (ABHR) to pregnant women for postnatal household use prevents severe infections (including sepsis, diarrhoea, pneumonia, or death) among infants during the first three postnatal months.Methods:Through a cluster-randomised trial in eastern Uganda, 72 clusters are randomised in a 2-arm design with rural villages as units of randomisation. We estimate to include a total of 5932 pregnant women at 34 weeks of gestation. All women and infants in the study are receiving standard antenatal and postnatal care. Women in the intervention group additionally receive six litres of ABHR and training on its use. Research midwives conduct follow-up visits at participants{\textquoteright} homes on days 1, 7, 28, 42, and 90 after birth and telephone calls on days 14, 48, and 60 to assess the mother and infant for study outcomes. Primary analyses will be by intention to treat. Discussion:This study will provide evidence on the effectiveness of a locally available and low-cost intervention in preventing neonatal sepsis and early infant infections. If ABHR is found effective, it could be implemented by adding it to birthing kits.Trial registration: Pan African Clinical Trial Registry, PACTR202004705649428. Registered 1 April 2020, https://pactr.samrc.ac.za/.",

keywords = "Alcohol-based hand rub, Infections, Neonatal, Newborn, Sepsis, Uganda",

author = "Martin Chebet and David Mukunya and Kathy Burgoine and K{\"u}hl, \{Melf Jakob\} and Duolao Wang and Antonieta Medina-Lara and Faragher, \{Eric Brian\} and Amos Odiit and Peter Olupot-Olupot and \{Stadskleiv Engebretsen\}, \{Ingunn Marie\} and Waniaye, \{John Baptist\} and Julius Wandabwa and Thorkild Tyllesk{\"a}r and Andrew Weeks",

year = "2023",

month = apr,

day = "17",

doi = "10.1186/s13063-023-07312-1",

language = "English",

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Chebet, M, Mukunya, D, Burgoine, K, Kühl, MJ, Wang, D, Medina-Lara, A, Faragher, EB, Odiit, A, Olupot-Olupot, P, Stadskleiv Engebretsen, IM, Waniaye, JB, Wandabwa, J, Tylleskär, T & Weeks, A 2023, 'A cluster randomised trial to evaluate the effectiveness of household alcohol-based hand rub for the prevention of sepsis, diarrhoea, and pneumonia in Ugandan infants (the BabyGel trial): a study protocol', Trials, vol. 24, no. 1, 279, pp. e279. https://doi.org/10.1186/s13063-023-07312-1

A cluster randomised trial to evaluate the effectiveness of household alcohol-based hand rub for the prevention of sepsis, diarrhoea, and pneumonia in Ugandan infants (the BabyGel trial): a study protocol. / Chebet, Martin; Mukunya, David; Burgoine, Kathy et al.
In: Trials, Vol. 24, No. 1, 279, 17.04.2023, p. e279.

Research output: Contribution to journal › Article › peer-review

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T1 - A cluster randomised trial to evaluate the effectiveness of household alcohol-based hand rub for the prevention of sepsis, diarrhoea, and pneumonia in Ugandan infants (the BabyGel trial): a study protocol

AU - Chebet, Martin

AU - Mukunya, David

AU - Burgoine, Kathy

AU - Kühl, Melf Jakob

AU - Wang, Duolao

AU - Medina-Lara, Antonieta

AU - Faragher, Eric Brian

AU - Odiit, Amos

AU - Olupot-Olupot, Peter

AU - Stadskleiv Engebretsen, Ingunn Marie

AU - Waniaye, John Baptist

AU - Wandabwa, Julius

AU - Tylleskär, Thorkild

AU - Weeks, Andrew

PY - 2023/4/17

Y1 - 2023/4/17

N2 - Background:Infections are one of the leading causes of death in the neonatal period. This trial aims to evaluate if the provision of alcohol-based hand rub (ABHR) to pregnant women for postnatal household use prevents severe infections (including sepsis, diarrhoea, pneumonia, or death) among infants during the first three postnatal months.Methods:Through a cluster-randomised trial in eastern Uganda, 72 clusters are randomised in a 2-arm design with rural villages as units of randomisation. We estimate to include a total of 5932 pregnant women at 34 weeks of gestation. All women and infants in the study are receiving standard antenatal and postnatal care. Women in the intervention group additionally receive six litres of ABHR and training on its use. Research midwives conduct follow-up visits at participants’ homes on days 1, 7, 28, 42, and 90 after birth and telephone calls on days 14, 48, and 60 to assess the mother and infant for study outcomes. Primary analyses will be by intention to treat. Discussion:This study will provide evidence on the effectiveness of a locally available and low-cost intervention in preventing neonatal sepsis and early infant infections. If ABHR is found effective, it could be implemented by adding it to birthing kits.Trial registration: Pan African Clinical Trial Registry, PACTR202004705649428. Registered 1 April 2020, https://pactr.samrc.ac.za/.

AB - Background:Infections are one of the leading causes of death in the neonatal period. This trial aims to evaluate if the provision of alcohol-based hand rub (ABHR) to pregnant women for postnatal household use prevents severe infections (including sepsis, diarrhoea, pneumonia, or death) among infants during the first three postnatal months.Methods:Through a cluster-randomised trial in eastern Uganda, 72 clusters are randomised in a 2-arm design with rural villages as units of randomisation. We estimate to include a total of 5932 pregnant women at 34 weeks of gestation. All women and infants in the study are receiving standard antenatal and postnatal care. Women in the intervention group additionally receive six litres of ABHR and training on its use. Research midwives conduct follow-up visits at participants’ homes on days 1, 7, 28, 42, and 90 after birth and telephone calls on days 14, 48, and 60 to assess the mother and infant for study outcomes. Primary analyses will be by intention to treat. Discussion:This study will provide evidence on the effectiveness of a locally available and low-cost intervention in preventing neonatal sepsis and early infant infections. If ABHR is found effective, it could be implemented by adding it to birthing kits.Trial registration: Pan African Clinical Trial Registry, PACTR202004705649428. Registered 1 April 2020, https://pactr.samrc.ac.za/.

KW - Alcohol-based hand rub

KW - Infections

KW - Neonatal

KW - Newborn

KW - Sepsis

KW - Uganda

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