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

Research output: Contribution to journalArticle

Abstract

Background: Infections 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. Methods: Three 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. Results: At 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. Conclusions: Cord 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 registration: Clinical Trial Registration: clinicaltrials.gov: NCT01528852,Registered February 7, 2012.

Original languageEnglish (US)
Article number121
JournalBMC Pediatrics
Volume16
Issue number1
DOIs
StatePublished - Aug 2 2016

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Chlorhexidine
India
Parturition
Placebos
Infant Mortality
Umbilicus
Growth
Gram-Negative Bacteria
Developing Countries
Clinical Trials
Mortality
Infection

Keywords

  • Bacterial count
  • Chlorhexidine
  • Colonization
  • Cord cleaning
  • India
  • Neonates
  • Newborns
  • Umbilical cord

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India : A randomized controlled study. / Nangia, Sushma; Dhingra, Usha; Dhingra, Pratibha; Dutta, Arup; Menon, Venugopal P.; Black, Robert E; Sazawal, Sunil.

In: BMC Pediatrics, Vol. 16, No. 1, 121, 02.08.2016.

Research output: Contribution to journalArticle

Nangia, Sushma ; Dhingra, Usha ; Dhingra, Pratibha ; Dutta, Arup ; Menon, Venugopal P. ; Black, Robert E ; Sazawal, Sunil. / Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India : A randomized controlled study. In: BMC Pediatrics. 2016 ; Vol. 16, No. 1.
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abstract = "Background: Infections 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. Methods: Three 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. Results: At 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. Conclusions: Cord 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 registration: Clinical Trial Registration: clinicaltrials.gov: NCT01528852,Registered February 7, 2012.",
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T1 - Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India

T2 - A randomized controlled study

AU - Nangia, Sushma

AU - Dhingra, Usha

AU - Dhingra, Pratibha

AU - Dutta, Arup

AU - Menon, Venugopal P.

AU - Black, Robert E

AU - Sazawal, Sunil

PY - 2016/8/2

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N2 - Background: Infections 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. Methods: Three 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. Results: At 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. Conclusions: Cord 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 registration: Clinical Trial Registration: clinicaltrials.gov: NCT01528852,Registered February 7, 2012.

AB - Background: Infections 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. Methods: Three 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. Results: At 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. Conclusions: Cord 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 registration: Clinical Trial Registration: clinicaltrials.gov: NCT01528852,Registered February 7, 2012.

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KW - India

KW - Neonates

KW - Newborns

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