TY - JOUR
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
U2 - 10.1186/s13063-023-07312-1
DO - 10.1186/s13063-023-07312-1
M3 - Article
SN - 1745-6215
VL - 24
SP - e279
JO - Trials
JF - Trials
IS - 1
M1 - 279
ER -
