Evidence map›Paper›PMID 27484013›Full record

Trial reportBMC pediatrics2016

Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India: a randomized controlled study.

Sushma Nangia, Usha Dhingra, Pratibha Dhingra, Arup Dutta, Venugopal P Menon, Robert E Black, Sunil Sazawal

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

Trial report in BMC pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01528852 (Efficacy of Use of Chlorhexidine to Clean Umbilical Cord of Neonates in First 10 Days for Reduction in Neonatal Mortality and Omphalitis - A Community Based Randomized, Double Masked Controlled Trial in Pemba Tanzania), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 15% 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.

NCT01528852 phase3completednot on this map

Efficacy of Use of Chlorhexidine to Clean Umbilical Cord of Neonates in First 10 Days for Reduction in Neonatal Mortality and Omphalitis - A Community Based Randomized, Double Masked Controlled Trial in Pemba Tanzania

TypeinterventionalSponsorJohns Hopkins Bloomberg School of Public HealthRan2011 to 2014Enrolled36,911ConditionsNeonatal Mortality, Cord Care, OmphalitisArmsChlorhexidine 4%, Control cord cleaning solution
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Umbilical cord antiseptics for preventing sepsis and death among newborns.The Cochrane database of systematic reviews · 2026
    Pooled it
  2. Umbilical Cord Stump Infections in Central Uganda: Incidence, Bacteriological Profile, and Risk Factors.International journal of environmental research and public health · 2022
    Article
  3. Review
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 2 institutions in 2 countries.

Sushma NangiaDepartment of Pediatrics, Lady Hardinge Medical College & Kalawati Saran Children's Hospital, New Delhi, India.
Usha DhingraDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
Pratibha DhingraCenter for Public Health Kinetics, New Delhi, India.
Arup DuttaCenter for Public Health Kinetics, New Delhi, India.
Venugopal P MenonCenter for Micronutrient Research, Clinical Trials and Operational Research in Maternal and Child Health, Annamalai, Tamil Nadu, India.
Robert E BlackDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
Sunil SazawalDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA. ssazawal@jhu.edu.
Johns Hopkins University · USKalawati Saran Children's Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfections are the single most important cause of neonatal mortality in developing countries. Results from trials in Asia evaluating the effect of chlorhexidine on neonatal mortality have been encouraging but limited data are available on the impact of cord cleansing on bacterial colonization. Further, no data from facility deliveries and impact with time is available. This pilot study was aimed to evaluate the impact of 4 % commercially prepared chlorhexidine on cord colonization and density of colonization among newborns in India.

methodsThree hundred twenty-six newborns (hospital-247; community-79) were enrolled within 24 h of birth and randomly assigned to one of three groups: chlorhexidine, placebo or dry cord care. Umbilical swabs were collected at baseline, 2- and 48- hours after intervention application.

resultsAt baseline, growth positivity (any bacterial growth) was 20 % (50 of 247 swabs) and 81 % (64 of 79 swabs) among hospital and community born neonates, respectively. In both settings, chlorhexidine compared to placebo and dry cord care, reduced colonization following 2- and 48-hour post application. Chlorhexidine significantly reduced 48-hour post application colony counts in comparison to placebo [Hospital: mean difference = -1.01; 95 % CI: -1.72, -0.30 Community: mean difference = -1.76; 95 % CI: -2.60, -0.93] and dry cord care [Hospital: mean difference = -1.16; 95 % CI: -1.93, -0.39 Community: mean difference = -2.23; 95 % CI: -3.18, -1.29]. Differences were similar for gram-positive and gram-negative bacteria.

conclusionsCord cleansing with 4 % chlorhexidine soon after birth reduced colonization as well as density of colonization significantly; however this pilot study does not address the impact of chlorhexidine on mortality. The control preparation neither increased or decreased colonization.

trial registrationCLINICAL

trial registrationclinicaltrials.gov: NCT01528852, Registered February 7, 2012.

Indexed as

Anti-Infective Agents, LocalBacterial LoadChlorhexidineFemaleGram-Negative BacteriaGram-Positive BacteriaHumansIndiaInfantInfant, NewbornMaleNeonatal SepsisPilot ProjectsPregnancyProspective StudiesUmbilical CordAnti-Infective Agents, LocalChlorhexidineBacterial countChlorhexidineColonizationCord cleaningIndiaNeonatesNewbornsUmbilical cord

Identifiers

PMID27484013
PMCPMC4971644
OpenAlexW2476684281

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.