Evidence map›Paper›PMID 37069595›Full record

ArticleTrials2023

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 and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 5 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 3 countries.

Martin ChebetFaculty of Health Sciences, Busitema University, Mbale, Uganda.
David MukunyaFaculty of Health Sciences, Busitema University, Mbale, Uganda. zebdaevid@gmail.com.ORCID http://orcid.org/0000-0002-3892-9777
Kathy BurgoineMbale Regional Referral Hospital, Mbale, Uganda.
Melf-Jakob KühlCentre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
Duolao WangLiverpool School of Tropical Medicine, Liverpool, UK.
Antonieta Medina-LaraDepartment of Public Health and Sport Sciences, University of Exeter, Exeter, UK.
Eric Brian FaragherLiverpool School of Tropical Medicine, Liverpool, UK.
Amos OdiitNgora Freda Carr Hospital, Ngora, Uganda.
Peter Olupot-OlupotFaculty of Health Sciences, Busitema University, Mbale, Uganda.
Ingunn Marie Stadskleiv EngebretsenCentre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
John Baptist WaniayeMinistry of Health, Kampala, Uganda.
Julius WandabwaFaculty of Health Sciences, Busitema University, Mbale, Uganda.
Thorkild TylleskärCentre for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
Andrew WeeksSanyu Research Unit, Department of Women's and Children's Health, University of Liverpool, Liverpool Women's Hospital, Crown Street, Liverpool, L8 7SS, UK.
Busitema University · UGUniversity of Bergen · NOLiverpool School of Tropical Medicine · GBMbale Hospital · UGMinistry of Health · UGUniversity of Exeter · GBUniversity of Liverpool · GB

Funding

European and Developing Countries Clinical Trials Partnership RIA2017MC-2029
6 · The paper itself

Abstract

backgroundInfections 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.

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

Indexed as

Neonatal SepsisPneumonia2-PropanolDiarrheaEthanolFemaleHumansInfantInfant, NewbornMothersPregnancyRandomized Controlled Trials as TopicUganda2-PropanolEthanolAlcohol-based hand rubInfectionsNeonatalNewbornSepsisUganda

Identifiers

PMID37069595
PMCPMC10106319
OpenAlexW4366221652

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.