Evidence map›Paper›PMID 16546539›Full record

Trial reportLancet (London, England)2006

Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial.

Luke C Mullany, Gary L Darmstadt, Subarna K Khatry, Joanne Katz, Steven C LeClerq, Shardaram Shrestha, Ramesh Adhikari, James M Tielsch

5 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 120 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
120citing papers in PubMed, 15 pooled it
41.6field-weighted citation impact, top 1% 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.

NCT00109616 phase3completednot on this map

Newborn Antiseptic Washing and Neonatal Mortality-Nepal

TypeinterventionalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran2002 to 2006Enrolled17,000ConditionsNeonatal MortalityArmsNewborn skin cleansing with 0.25% chlorhexidine solution, Cleansing of umbilical cord with soap and water solution, Cleansing of umbilical cord with 4% chlorhexidine
NCT00434408 phase3completednot on this mapstarted 2007, after this paper: background citation

Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh

TypeinterventionalSponsorJohns Hopkins Bloomberg School of Public HealthRan2007 to 2010Enrolled28,797ConditionsOmphalitis, InfectionArmschx once, CHX x 7 days, dry cord care
NCT01241318 phase2 / phase3completednot on this mapstarted 2011, after this paper: background citation

Impact of Chlorhexidine Cord Cleansing for Prevention of Neonatal Mortality in Zambia

TypeinterventionalSponsorBoston UniversityRan2011 to 2013Enrolled77,535ConditionsSepsisArmsChlorhexidine gluconate (4%), Dry cord care
NCT02130856 phase3completednot on this mapstarted 2014, after this paper: background citation

An Integrated Toolkit to Save Newborn Lives in Pakistan

TypeinterventionalSponsorThe Hospital for Sick ChildrenRan2014 to 2017Enrolled8,518ConditionsNeonatal MortalityArmsNeonatal kit
NCT02208960 phase3completednot on this mapstarted 2014, after this paper: background citation

An Integrated Toolkit to Save Newborn Lives and Brains in Kenya

TypeinterventionalSponsorThe Hospital for Sick ChildrenRan2014 to 2016Enrolled2,294ConditionsNeurodevelopment, Neonatal MortalityArmsNeonatal Kit, Neonatal Stimulation
3 · Its place in the literature

Who cites it

120 citing papers in PubMed, 15 syntheses or guidelines pooled it, 313 citations in OpenAlex.

  1. Pooled it
  2. Umbilical cord antiseptics for preventing sepsis and death among newborns.The Cochrane database of systematic reviews · 2026
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  7. Umbilical cord cleansing with chlorhexidine in neonates: a systematic review.Journal of perinatology : official journal of the California Perinatal Association · 2016
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  11. Umbilical cord antiseptics for preventing sepsis and death among newborns.The Cochrane database of systematic reviews · 2013
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60 more citing papers are in PubMed but not listed here.

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

8 authors at 3 institutions in 2 countries.

Luke C MullanyDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21211, USA. lmullany@jhsph.edu
Gary L Darmstadt
Subarna K Khatry
Joanne Katz
Steven C LeClerq
Shardaram Shrestha
Ramesh Adhikari
James M Tielsch
Bloomberg (United States) · USJohns Hopkins University · USTribhuvan University · NP

Funding

ZINC SUPPLEMENTATION IMPACT ON CHILD MORTALITY--NEPALR01HD038753 · NICHD · JOHNS HOPKINS UNIVERSITY · PI TIELSCH, JAMES M · 2000 to 2003
$3.5M
Newborn Antiseptic Washing and Neonatal Mortality-NepalR01HD044004 · NICHD · JOHNS HOPKINS UNIVERSITY · PI TIELSCH, JAMES M · 2003 to 2005
$1.5M
NICHD NIH HHS HD38753NICHD NIH HHS HD44004NICHD NIH HHS R01 HD038753NICHD NIH HHS R01 HD044004
6 · The paper itself

Abstract

backgroundOmphalitis contributes to neonatal morbidity and mortality in developing countries. Umbilical cord cleansing with antiseptics might reduce infection and mortality risk, but has not been rigorously investigated.

methodsIn our community-based, cluster-randomised trial, 413 communities in Sarlahi, Nepal, were randomly assigned to one of three cord-care regimens. 4934 infants were assigned to 4.0% chlorhexidine, 5107 to cleansing with soap and water, and 5082 to dry cord care. In intervention clusters, the newborn cord was cleansed in the home on days 1-4, 6, 8, and 10. In all clusters, the cord was examined for signs of infection (pus, redness, or swelling) on these visits and in follow-up visits on days 12, 14, 21, and 28. Incidence of omphalitis was defined under three sign-based algorithms, with increasing severity. Infant vital status was recorded for 28 completed days. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. Analysis was by intention-to-treat. This trial is registered with , number NCT00109616.

findingsFrequency of omphalitis by all three definitions was reduced significantly in the chlorhexidine group. Severe omphalitis in chlorhexidine clusters was reduced by 75% (incidence rate ratio 0.25, 95% CI 0.12-0.53; 13 infections/4839 neonatal periods) compared with dry cord-care clusters (52/4930). Neonatal mortality was 24% lower in the chlorhexidine group (relative risk 0.76 [95% CI 0.55-1.04]) than in the dry cord care group. In infants enrolled within the first 24 h, mortality was significantly reduced by 34% in the chlorhexidine group (0.66 [0.46-0.95]). Soap and water did not reduce infection or mortality risk.

interpretationRecommendations for dry cord care should be reconsidered on the basis of these findings that early antisepsis with chlorhexidine of the umbilical cord reduces local cord infections and overall neonatal mortality.

Indexed as

Administration, TopicalAnti-Infective Agents, LocalChlorhexidineFemaleHernia, UmbilicalHumansIncidenceInfant MortalityInfant, NewbornMaleNepalSoapsSocial ClassUmbilical CordAnti-Infective Agents, LocalChlorhexidineSoaps

Identifiers

PMID16546539
PMCPMC2367116
OpenAlexW2098841625

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.