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Cited by 124Neonatal skin health careGlobal Maternal and Child HealthMaternal and Neonatal Healthcare

Impact of Newborn Skin-Cleansing With Chlorhexidine on Neonatal Mortality in Southern Nepal: A Community-Based, Cluster-Randomized Trial

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Tielsch, James M., Darmstadt, Gary L., Mullany, Luke C., Khatry, Subarna K., Katz, Joanne, LeClerq, Steven C., Shrestha, Shardaram, Adhikari, Ramesh·2007·Pediatrics
DOI 10.1542/peds.2006-1192PMC PMC2364722
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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 17530 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 ≥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.

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  • Despite post-randomization identification and recruitment, there is no risk of identification and recruitment bias because the placebo control ensures recruitment is blind to the intervention condition.

    “despite the use of post-randomization identification and recruitment, there is no risk of identification and recruitment bias because the placebo control ensures recruitment is blind to the intervention condition.”

    From Cluster randomized trials of individual-level interventions were at high risk of bias (2021) · cites this paper as [32]

    The Methods (Eligibility and Randomization; Intervention; page unavailable) say newborns were enrolled after sector randomization and that investigators and all study staff were masked to treatment assignment. This supports blinded recruitment, but the paper does not conclude that there was no risk of identification and recruitment bias; that absolute assessment goes beyond what it reports. (LLM, conf=0.83)

    Experimental — accuracy not yet measured

  • The one trial identified as low risk of bias was a trial of skin cleansing wipe in new-born babies with a placebo control.

    “The one trial identified as low risk of bias was a trial of skin cleansing wipe in new-born babies with a placebo control [32].”

    From Cluster randomized trials of individual-level interventions were at high risk of bias (2021) · cites this paper as [32]

  • In the low risk trial, outcome assessment is blinded and objective (mortality).

    “Furthermore, the outcome assessment is blinded (and in this trial also happened to be objective, namely mortality).”

    From Cluster randomized trials of individual-level interventions were at high risk of bias (2021) · cites this paper as [32]

  • The placebo control helps minimize risk of bias in most domains.

    “The placebo control helps minimize risk of bias in most domains”

    From Cluster randomized trials of individual-level interventions were at high risk of bias (2021) · cites this paper as [32]

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Research works printed but not linked: 7

  1. [4]Costello A Manandhar D Costello A Manandhar D Current state of the health of newborn infants in developing countries. Improving Newborn Infant Health in Developing Countries 2000 1 14 Imperial College Press London, England
  2. [5]Rahmathullah L Tielsch JM Thulasiraj RD Impact of newborn vitamin A dosing on early infant mortality: a community-based randomized trial in south India. Br Med J 2003 327 254 12896935 PMC167159
  3. [9]Christensen KK Christensen P Chlorhexidine for prevention of neonatal colonization with GBS. Antibiot Chemother 1985 35 296 302 3901906
  4. [21]Darmstadt GL Badrawi N Law PA Topical therapy with sunflower seed oil prevents nosocomial infections and mortality in premature babies in Egypt: a randomized, controlled clinical trial. Pediatr Infect Dis J 2004 23 719 725 15295221
  5. [32]Williams M Eichenfield L Frieden I Esterly N Skin of the premature infant. Textbook of Neonatal Dermatology 2001 46 61 WB Saunders Co Philadelphia, PA
  6. [36]Mullany L Darmstadt GL Tielsch J Role of antimicrobial applications to the umbilical cord on bacterial colonization and infection. Pediatr Infect Dis J 2003 22 996 1002 14614373 PMC1317298
  7. [38]Denton GW Block SS Chlorhexidine. Disinfection, Sterilization, and Preservation 2001 321 326 Lippincott Williams & Wilkins Philadelphia, PA 5th ed.

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Authors
Tielsch, J. M., Darmstadt, G. L., Mullany, L. C., Khatry, S. K., Katz, J., LeClerq, S. C., Shrestha, S., & Adhikari, R.
Affiliations
  • Johns Hopkins University (US)
  • Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal
  • Tribhuvan University (NP)
ORCID
Venue
Pediatrics
Publisher
American Academy of Pediatrics (AAP)
Published
2007-02-01
Volume
119
Issue
2
Pages
e330-e340
ISSN
  • 0031-4005 (ISSN-L)
  • 1098-4275
DOI
10.1542/peds.2006-1192
PMC
PMC2364722
OpenAlex
W2041823601
Cited by
124
References
24
Citations by year
2026: 1 · 2025: 2 · 2024: 5 · 2023: 1 · 2022: 3 · 2021: 4 · 2019: 3 · 2018: 3 · 2017: 6 · 2016: 7 · 2015: 9 · 2014: 8 · 2013: 11 · 2012: 6
FWCI
42.57
Type
journal article
Language
en
Open access
Locations
  • PEDIATRICS (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD038753, HD 38753, HD 44004, R01HD044004)
Topics
  • Health Sciences › Health Professions › Speech and Hearing › Neonatal skin health care
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Global Maternal and Child Health
  • Health Sciences › Health Professions › General Health Professions › Maternal and Neonatal Healthcare
Keywords
chlorhexidine, neonatal mortality, low birth weight infants, home delivery, infant hygiene, neonatal infection prevention, community-based intervention, Nepal
MeSH terms
Anti-Infective Agents, Local, Antisepsis, Chlorhexidine, Female, Humans, Infant, Newborn, Infant, Newborn, Diseases, Male, Nepal, Skin, Cluster Analysis

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