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Chlorhexidine Gel Versus Aqueous for Preventive Use on Umbilical Stump: A Randomized Noninferiority Trial

Hodgins, Stephen MD, DrPH*; Thapa, Kusum MB BS; Khanal, Leela MPH; Aryal, Shilu MB BS§; Suvedi, Bal Krishna MB BS§; Baidya, Urmilla; Mullany, Luke C. PhD, MHS

The Pediatric Infectious Disease Journal: November 2010 - Volume 29 - Issue 11 - p 999-1003
doi: 10.1097/INF.0b013e3181e70c59
Original Studies
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Background: Recent trials of chlorhexidine cord cleansing have employed aqueous solution applied with cotton swabs. Care-takers may prefer gel, resulting in better compliance when implemented at large scale. We examined whether a guar-gum-thickened formulation was at least as efficacious as aqueous in reducing periumbilical flora.

Methods: Newborns (n = 694) from normal deliveries at a hospital in Kathmandu were randomly allocated to cord cleansing with either gel or aqueous chlorhexidine, applied by finger. Immediately before and 24 hours after cleansing, periumbilical swabs were collected and cultured. The primary outcome was periumbilical colonization at 24 hours. Household-level acceptability and ease of use in a rural setting where most deliveries are not attended by health workers were assessed by providing 61 women with either gel or aqueous formulations and following up on their experience using the products.

Results: Babies allocated to gel and aqueous chlorhexidine were comparable on a range of variables measured at baseline. At 24 hours postapplication, 4.6% (15 of 327) of cultures were positive in the gel group and 10.7% (35 of 326) in the aqueous group. The absolute difference in rates (gel minus aqueous) was −6.1% (95% CI: −10.2%, −2.1%). The acceptability study found that satisfaction and compliance were high for both; use of either largely displaced the traditional use of oil-based mixtures. Overall, there was a preference for gel.

Conclusions: The gel formulation was not inferior to aqueous and gel reduced bacterial colonization to a greater degree. A gel formulation might be considered in future research or program settings where chlorhexidine cleansing of the cord is being evaluated or promoted.

From the *Maternal Child Health Integrated Program/John Snow Inc., Washington, DC; †Paropakar Mothers and Women's Hospital, Kathmandu, Nepal; ‡Nepal Family Health Program—II/JSI R&T, Kathmandu, Nepal; §Family Health Division, Department of Health Services, Ministry of Health and Population, Kathmandu, Nepal; and ¶Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.

Accepted for publication April 27, 2010.

Supported by United States Agency for International Development, through a Nepal-based bilateral project (the Nepal Family Health Program II, implemented by JSI R&T; CA#: 367-00-02-00017-00).

USAID did not play a role in study design; in the collection, analysis, and interpretation of data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.

Authors' contributions: S.H. took primary responsibility for study design, analysis and drafting of the manuscript. K.T. and L.K. contributed in the design and conduct of the study and in critical review of the manuscript and directly managed conduct of the study. L.C.M. contributed to design of the study and preparation of the manuscript. S.A. and B.K.S. reviewed and provided critical input in the design and write-up. U.B. took primary responsibility for lab aspects of the study, including design, conduct and critical review of the draft.

Address for correspondence: Stephen Hodgins, MD, DrPH, 1776 Massachusetts Ave, Suite 300, Washington, DC 20036. E-mail: shodgins@mchip.net.

© 2010 Lippincott Williams & Wilkins, Inc.