title: Impact of newborn skin-cleansing with chlorhexidine on neonatal mortality in southern Nepal: a community-based, cluster-randomized trial.
abstract: OBJECTIVE
  Hospital-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.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  A 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.
  
  
  CONCLUSIONS
  Newborn 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.
authors.affiliation: Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA. jtielsch@jhsph.edu
authors.forename: James M
authors.initials: JM
authors.lastname: Tielsch
authors.forename: Gary L
authors.initials: GL
authors.lastname: Darmstadt
authors.forename: Luke C
authors.initials: LC
authors.lastname: Mullany
authors.forename: Subarna K
authors.initials: SK
authors.lastname: Khatry
authors.forename: Joanne
authors.initials: J
authors.lastname: Katz
authors.forename: Steven C
authors.initials: SC
authors.lastname: LeClerq
authors.forename: Shardaram
authors.initials: S
authors.lastname: Shrestha
authors.forename: Ramesh
authors.initials: R
authors.lastname: Adhikari
mesh_terms: D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D000985:Antisepsis; D002710:Chlorhexidine / Q000627:therapeutic use*; D016000:Cluster Analysis; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000401:mortality* / Q000517:prevention & control*; D008297:Male; D009390:Nepal; D012867:Skin
chemical_list: D000891:Anti-Infective Agents, Local; D002710:Chlorhexidine