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.

Autor: Chebet M; Faculty of Health Sciences, Busitema University, Mbale, Uganda.; Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.; Sanyu Africa Research Institute, Mbale, Uganda., Mukunya D; Faculty of Health Sciences, Busitema University, Mbale, Uganda. zebdaevid@gmail.com., Burgoine K; Mbale Regional Referral Hospital, Mbale, Uganda., Kühl MJ; Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway., Wang D; Liverpool School of Tropical Medicine, Liverpool, UK., Medina-Lara A; Department of Public Health and Sport Sciences, University of Exeter, Exeter, UK., Faragher EB; Liverpool School of Tropical Medicine, Liverpool, UK., Odiit A; Ngora Freda Carr Hospital, Ngora, Uganda., Olupot-Olupot P; Faculty of Health Sciences, Busitema University, Mbale, Uganda.; Mbale Clinical Research Institute, Mbale, Uganda., Stadskleiv Engebretsen IM; Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway., Waniaye JB; Ministry of Health, Kampala, Uganda., Wandabwa J; Faculty of Health Sciences, Busitema University, Mbale, Uganda., Tylleskär T; Centre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway., Weeks A; Sanyu Research Unit, Department of Women's and Children's Health, University of Liverpool, Liverpool Women's Hospital, Crown Street, Liverpool, L8 7SS, UK.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Apr 17; Vol. 24 (1), pp. 279. Date of Electronic Publication: 2023 Apr 17.
DOI: 10.1186/s13063-023-07312-1
Abstrakt: 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/ .
(© 2023. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje