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Randomized Controlled Trial
. 2018 Nov 20;18(1):1279.
doi: 10.1186/s12889-018-6201-3.

Preventing neonatal sepsis in rural Uganda: a cross-over study comparing the tolerance and acceptability of three alcohol-based hand rub formulations

J Ditai  1   2 , M Mudoola  3 , M Gladstone  4 , J Abeso  3   5 , J Dusabe-Richards  6   7 , M Adengo  3 , P Olupot-Olupot  8   9 , E D Carrol  10 , J Storr  11   12 , A Medina-Lara  13 , B Faragher  6   7 , A D Weeks  3   4
Affiliations
Randomized Controlled Trial

Preventing neonatal sepsis in rural Uganda: a cross-over study comparing the tolerance and acceptability of three alcohol-based hand rub formulations

J Ditai et al. BMC Public Health. .

Abstract

Background: Neonatal sepsis causes 0.5 million deaths annually, mostly in low resource settings. Babies born in African rural homes without running water or toilet facilities are especially vulnerable. Alcohol-based hand rub (ABHR) may be used by mothers and carers as an alternative to hand washing with soap to prevent neonatal infection. However, no definite study has established the preferred formulation of hand rub for the mothers. This study aimed to assess the effects of addition of bitterants and perfume towards the acceptability of the alcohol-based hand rubs by the mothers in their homes after childbirth.

Methods: This was a 3-way blinded cross-over study design. Mothers with children aged ≤3 months were recruited from immunisation clinics at 3 local health facilities in rural eastern Uganda and received 3-different ABHR formulations (in the order plain, bitterant and perfumed) packed in 100 ml bottles. Each ABHR was used for 5 consecutive days followed by a 2-day 'washout' period (evaluation period). Overall satisfaction with each hand rub was evaluated at the end of each week using a 7-point Likert scale.

Results: A total of 43 women were recruited, whose ages ranged from 16 to 45 years (mean 26.2 years old). None of the participants normally used a hand protective lotion/cream. The three formulations were used for a mean of 5 (range 3-7) days. A significantly greater volume of the "bitterant" and "perfumed" formulations (mean 91 and 83 ml respectively) were used in comparison to the "plain" formulation (mean 64 ml). Overall satisfaction was high with all the hand rubs, but the perfumed formulation had a significantly higher overall satisfaction score [mean 6.7, range 4-7] compared with the plain [6.4, 3-7] and bitterant [6.2, 2-7] formulations.

Conclusions: All the 3 ABHR formulations were well accepted with little to choose between them. The ABHR with added perfume scored highest on overall satisfaction and was used significantly more often than plain ABHR. ABHR with bitterant additive did, however, score highly and may be a preferable choice to those with concern over alcohol misuse.

Trial registration: ISRCTN67852437 , prospectively registered on 18/03/2018.

Keywords: Acceptability; Alcohol-based hand rubs; Bitterant; Hand hygiene; Maternal infection; Neonatal infection; Perfume.

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Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Mbale Regional Hospital Institutional Review Committee (REIRC IN – COM 011/2015), the University of Liverpool Research and Ethics committee (RETH000808), and the Uganda National Council for Science and Technology (HS1768). Written informed consent for participation in the pilot trial was obtained from all participants before recruitment.

Consent for publication

Not Applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The ‘3 Moments for community neonatal hand hygiene’ poster developed for BabyGel study. This shows an illustrative and diagrammatic representation of the key moments of hand hygiene for newborns in the community
Fig. 2
Fig. 2
The Glass model for Likert scale evaluation of the opinion of Carers/ mothers after use of the test product. The glass models were labelled from 1 to 7 consistent with the filling levels and each participant was asked to indicate where she felt it is the best option for her following use of the product
Fig. 3
Fig. 3
Participants flow in the study. This shows the potential participants screened and those recruited and the allocation to the ABHR formulations
See this image and copyright information in PMC

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