Evidence map›Paper›PMID 28701228›Full record

Trial reportTrials2017

Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial.

Victoria Nankabirwa, Thorkild Tylleskär, Josephine Tumuhamye, James K Tumwine, Grace Ndeezi, José C Martines, Halvor Sommerfelt

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02606565 (Acceptability and Efficacy of Umbilical Cord Cleansing With 4% Chlorhexidine for the Prevention of Newborn Infections in Lira District, Northern Uganda), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% 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.

NCT02606565 phase4completednot on this map

Acceptability and Efficacy of Umbilical Cord Cleansing With 4% Chlorhexidine for the Prevention of Newborn Infections in Lira District, Northern Uganda: A Randomised Controlled Trial

TypeinterventionalSponsorMakerere UniversityRan2016 to 2020Enrolled4,760ConditionsOmphalitis, SepticaemiaArmsIntervention arm: 4% chlorhexidine
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Umbilical cord antiseptics for preventing sepsis and death among newborns.The Cochrane database of systematic reviews · 2026
    Pooled it
  2. Article
  3. Article
  4. Article
  5. Umbilical Cord Stump Infections in Central Uganda: Incidence, Bacteriological Profile, and Risk Factors.International journal of environmental research and public health · 2022
    Article
  6. Observational
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
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

7 authors at 3 institutions in 2 countries.

Victoria NankabirwaDepartment of Epidemiology and Biostatistics, School of Public Health, College of Health Sciences, Makerere University, PO Box 7072, Kampala, Uganda. nankabirwav@gmail.com.ORCID 0000-0002-9952-8942
Thorkild TylleskärCentre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen, Bergen, Norway.
Josephine TumuhamyeCentre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen, Bergen, Norway.
James K TumwineDepartment of Paediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.
Grace NdeeziDepartment of Paediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.
José C MartinesCentre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen, Bergen, Norway.
Halvor SommerfeltCentre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen, Bergen, Norway.
University of Bergen · NOMakerere University · UGNorwegian Institute of Public Health · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundYearly, nearly all the estimated worldwide 2.7 million neonatal deaths occur in low- and middle-income countries. Infections, including those affecting the umbilical cord (omphalitis), are a significant factor in approximately a third of these deaths. In fact, the odds of all-cause mortality are 46% higher among neonates with omphalitis than in those without. Five large randomized controlled trials in Asia and Sub-Saharan Africa (SSA) have examined the effect of multiple cord stump applications with 4% chlorhexidine (CHX) for at least 7 days on the risk of omphalitis and neonatal death. These studies, all community-based, show that multiple CHX applications reduced the risk of omphalitis. Of these trials, only one study from South Asia (the Bangladeshi study) and none from Africa examined the effect of a single application of CHX as soon as possible after birth. In this Bangladeshi trial, CHX led to a reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an African setting, to explore the effect of a single application among health-facility births. A single application is programmatically much simpler to implement than daily applications for 7 days. Therefore, our study compares umbilical cord cleansing with a single application of 4% CHX at birth with dry cord care among Ugandan babies born in health facilities, on the risk of omphalitis and severe neonatal illness.

methodsThe CHX study is a facility-based, individually randomized controlled trial that will be conducted among 4760 newborns in Uganda. The primary outcomes are severe illness and omphalitis during the neonatal period. Analysis will be by intention-to-treat. DISCUSSION: This study will provide novel evidence, from a Sub-Saharan African setting, of the effect of umbilical cord cleansing with a single application of 4% CHX at birth and identify modifiable risk factors for omphalitis.

trial registrationClinicalTrials.gov, identifier: NCT02606565 . Registered on 12 November 2015.

Indexed as

Administration, TopicalAnti-Infective Agents, LocalBacterial InfectionsChlorhexidineClinical ProtocolsCommunicable Disease ControlFemaleHumansInfant, NewbornInfant, Newborn, DiseasesPregnancyResearch DesignRisk FactorsTime FactorsTreatment OutcomeUgandaAnti-Infective Agents, LocalChlorhexidineChlorhexidineNeonatalNewbornOmphalitisSevere illnessTrial

Identifiers

PMID28701228
PMCPMC5508681
OpenAlexW2736110077

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.