title: 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.
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.
  
  
  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.
authors.affiliation: Hospital for Children and Adolescents, University of Leipzig, Liebigstrasse 20A Leipzig DE-04103, Germany. kapt@medizin.uni-leipzig.de
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Kapellen
authors.forename: Corinna M
authors.initials: CM
authors.lastname: Gebauer
authors.forename: Oana
authors.initials: O
authors.lastname: Brosteanu
authors.forename: Birgit
authors.initials: B
authors.lastname: Labitzke
authors.forename: Christoph
authors.initials: C
authors.lastname: Vogtmann
authors.forename: Wieland
authors.initials: W
authors.lastname: Kiess
mesh_terms: D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000453:epidemiology / Q000517:prevention & control; D002710:Chlorhexidine / Q000008:administration & dosage*; D006099:Granuloma / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D007224:Infant Care / Q000379:methods*; D007231:Infant, Newborn; D011208:Powders; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014470:Umbilical Cord / Q000382:microbiology; D014472:Umbilicus
chemical_list: D000891:Anti-Infective Agents, Local; D011208:Powders; D002710:Chlorhexidine