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, Kühl, Melf-Jakob, Wang, Duolao ORCID: https://orcid.org/0000-0003-2788-2464, Medina-Lara, Antonieta, Faragher, Brian, Odiit, Amos, Olupot-Olupot, Peter, Stadskleiv Engebretsen, Ingunn Marie, Waniaye, John Baptist, Wandabwa, Julius, Tylleskär, Thorkild and Weeks, Andrew (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, Issue 1, e279.

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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/.

Item Type:	Article
Subjects:	WC Communicable Diseases > Infection. Bacterial Infections > Bacterial Infections > WC 202 Pneumonia (General or not elsewhere classified) WC Communicable Diseases > Infection. Bacterial Infections > Bacterial Infections > WC 240 Bacteremia. Sepsis. Toxemias WQ Obstetrics > Pregnancy > WQ 200 General works WS Pediatrics > By Age Groups > WS 420 Newborn infants. Neonatology WS Pediatrics > By Age Groups > WS 430 Infancy
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1186/s13063-023-07312-1
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	18 Apr 2023 12:34
Last Modified:	18 Apr 2023 12:34
URI:	https://archive.lstmed.ac.uk/id/eprint/22334

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