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Table of Contents
Vol. 96, No. 1, 2009
Issue release date: June 2009
Section title: Original Paper
Neonatology 2009;96:13–18
(DOI:10.1159/000200165)

Higher Rate of Cord-Related Adverse Events in Neonates with Dry Umbilical Cord Care Compared to Chlorhexidine Powder

Results of a Randomized Controlled Study to Compare Efficacy and Safety of Chlorhexidine Powder versus Dry Care in Umbilical Cord Care of the Newborn

Kapellen T.M.a, b · Gebauer C.M.a, b · Brosteanu O.b · Labitzke B.b · Vogtmann C.a · Kiess W.a
aHospital for Children and Adolescents, bCoordination Centre for Clinical Trials (KKSL), University of Leipzig, Leipzig, Germany

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: February 27, 2008
Accepted: August 18, 2008
Published online: February 07, 2009
Issue release date: June 2009

Number of Print Pages: 6
Number of Figures: 1
Number of Tables: 1

ISSN: 1661-7800 (Print)
eISSN: 1661-7819 (Online)

For additional information: http://www.karger.com/NEO

Abstract

Objective: Best practice for umbilical cord care (UC) still remains controversial in developed countries with aseptic perinatal care. A bicenter randomized clinical trial was performed to evaluate the efficacy of chlorhexidine (CX) powder versus dry cord care (DC) for UC. Patients and Methods: All neonates of two neonatal care units were invited to take part in the study. Participants were randomized to either DC or UC with CX powder (0.1%). Primary study outcome was the cord separation time. Secondary outcomes were omphalitis, granuloma of the umbilical ground, adverse events and parents’ treatment satisfaction. The outcome parameters were documented at a hospital-located study visit 10–14 days after birth. Results: 669 neonates were enrolled in the trial. 337 were randomized to receive CX powder for umbilical cord care, 332 to DC. Cord separation time was 7.0 ± 2.5 days in CX-treated neonates and 7.8 ± 2.9 days in DC (p < 0.001). There were 9 cases of omphalitis, 2 in the CX group, 7 in the DC group (p = 0.1). No difference in the occurrence of umbilical granuloma between the treatment regimens was detected. Neonates randomized to CX were less likely to have an adverse event (140 in 109 subjects vs. 205 in 149 subjects in the DC neonates; p = 0.001). Half of these adverse events were cord-related. Neonates randomized to DC had nearly twice as many cord-related adverse events as those with CX treatment (CX: 58 in 54 patients vs. DC: 110 in 97 patients; p < 0.001). Parents’ treatment satisfaction was significantly higher in the neonates with CX cord care. Conclusions: Cord-related adverse events in neonatal umbilical cord care remain a clinical issue. Even in an aseptic birth context in a developed country, cord care with CX powder showed a reduction of cord-related adverse events.

© 2009 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: February 27, 2008
Accepted: August 18, 2008
Published online: February 07, 2009
Issue release date: June 2009

Number of Print Pages: 6
Number of Figures: 1
Number of Tables: 1

ISSN: 1661-7800 (Print)
eISSN: 1661-7819 (Online)

For additional information: http://www.karger.com/NEO


Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.