Evidence map›Paper›PMID 17210728›Full record

Trial reportPediatrics2007

Impact of newborn skin-cleansing with chlorhexidine on neonatal mortality in southern Nepal: a community-based, cluster-randomized trial.

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

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatrics, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00109616 (Newborn Antiseptic Washing and Neonatal Mortality-Nepal), which is not on this map. Cited by 75 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 14 pooled it
33.5field-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
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 14 syntheses or guidelines pooled it, 122 citations in OpenAlex.

  1. Pooled it
  2. Skin care interventions in infants for preventing eczema and food allergy.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Skin care interventions in infants for preventing eczema and food allergy.The Cochrane database of systematic reviews · 2021
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  10. Umbilical cord antiseptics for preventing sepsis and death among newborns.The Cochrane database of systematic reviews · 2013
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15 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

James M TielschDepartment of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA. jtielsch@jhsph.edu
Gary L Darmstadt
Luke C Mullany
Subarna K Khatry
Joanne Katz
Steven C LeClerq
Shardaram Shrestha
Ramesh Adhikari
Johns 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 HD 38753NICHD NIH HHS HD 44004NICHD NIH HHS R01 HD038753NICHD NIH HHS R01 HD044004
6 · The paper itself

Abstract

objectiveHospital-based data from Africa suggest that newborn skin-cleansing with chlorhexidine may reduce neonatal mortality. Evaluation of this intervention in the communities where most births occur in the home has not been done. Our objective was to assess the efficacy of a 1-time skin-cleansing of newborn infants with 0.25% chlorhexidine on neonatal mortality.

methodsThe design was a community-based, placebo-controlled, cluster-randomized trial in Sarlahi District in southern Nepal. Newborn infants were cleansed with infant wipes that contained 0.25% chlorhexidine or placebo solution as soon as possible after delivery in the home (median: 5.8 hours). The primary outcome was all-cause mortality by 28 days. After the completion of the randomized phase, all newborns in study clusters were converted to chlorhexidine treatment for the subsequent 9 months.

resultsA total of 17,530 live births occurred in the enrolled sectors, 8650 and 8880 in the chlorhexidine and placebo groups, respectively. Baseline characteristics were similar in the treatment groups. Intention-to-treat analysis among all live births showed no impact of the intervention on neonatal mortality. Among live-born infants who actually received their assigned treatment (98.7%), there was a nonsignificant 11% lower neonatal mortality rate among those who were treated with chlorhexidine compared with placebo. Low birth weight infants had a statistically significant 28% reduction in neonatal mortality; there was no significant difference among infants who were born weighing > or = 2500 g. After conversion to active treatment in the placebo clusters, there was a 37% reduction in mortality among low birth weight infants in the placebo clusters versus no change in the chlorhexidine clusters.

conclusionsNewborn skin-wiping with chlorhexidine solution once, soon after birth, reduced neonatal mortality only among low birth weight infants. Evidence from additional trials is needed to determine whether this inexpensive and simple intervention could improve survival significantly among low birth weight infants in settings where home delivery is common and hygiene practices are poor.

Indexed as

AntisepsisSkinAnti-Infective Agents, LocalChlorhexidineCluster AnalysisFemaleHumansInfant, NewbornInfant, Newborn, DiseasesMaleNepalAnti-Infective Agents, LocalChlorhexidine

Identifiers

PMID17210728
PMCPMC2364722
OpenAlexW2041823601

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.