title: Dry Care Versus Antiseptics for Umbilical Cord Care: A Cluster Randomized Trial.
abstract: In developed countries, where omphalitis has become rare and related mortality nil, benefits of antiseptic use in umbilical cord care have not been demonstrated. We aimed to assess the noninferiority of dry care compared with antiseptics in France where antiseptic use is widespread.
  
  
  
  We conducted a noninferiority, cluster-randomized, 2-period crossover trial, in 6 French university maternity units including all infants born after 36 weeks' gestation. Maternity units were randomly assigned to provide either their usual antiseptic care or a dry care umbilical cord method for a 4-month period, and then units switched to the alternate cord cleansing method for a 4-month period. The primary outcome was neonatal omphalitis, adjudicated by an independent blinded committee based on all available photographs, clinical, and bacteriological data. We used a noninferiority margin of 0.4%. Analysis was performed per protocol and by intention to treat.
  
  
  
  Among 8698 participants, omphalitis occurred in 3 of 4293 (0.07%) newborns in the dry care group and in none of the 4404 newborns in the antiseptic care group (crude difference: 0.07; 95% confidence interval: -0.03 to 0.21). Late neonatal infection, parental appreciation of difficulty in care, and time to separation of the cord were not significantly different between the 2 groups.
  
  
  
  Dry cord was noninferior to the use of antiseptics in preventing omphalitis in full-term newborns in a developed country. Antiseptic use in umbilical cord care is therefore unnecessary, constraining, and expensive in high-income countries and may be replaced by dry care.
authors.affiliation: Service de Pédiatrie, christele.grasleguen@chu-nantes.fr.|National Institutes of Health and Medical Research, CIC 1413, and.|EA 3628, Thérapeutiques anti infectieuses, Faculté de médecine, Université de Nantes, Nantes, France.
authors.forename: Christèle
authors.initials: C
authors.lastname: Gras-Le Guen
authors.affiliation: National Institutes of Health and Medical Research, CIC 1415, Hôpital Bretonneau, and.
authors.forename: Agnès
authors.initials: A
authors.lastname: Caille
authors.affiliation: Service de Pédiatrie.|National Institutes of Health and Medical Research, CIC 1413, and.
authors.forename: Elise
authors.initials: E
authors.lastname: Launay
authors.affiliation: Service de Pédiatrie.|National Institutes of Health and Medical Research, CIC 1413, and.
authors.forename: Cécile
authors.initials: C
authors.lastname: Boscher
authors.affiliation: Service de Pédiatrie.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Godon
authors.affiliation: Pédiatrie de Maternité, Centre Hospitalier Universitaire d'Angers, Angers, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Savagner
authors.affiliation: Pédiatrie de Maternité, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Descombes
authors.affiliation: Pédiatrie de Maternité, Centre Hospitalier Universitaire Brest, Brest France; and.
authors.forename: Gisèle
authors.initials: G
authors.lastname: Gremmo-Feger
authors.affiliation: Service de pédiatrie-néonatologie et maternité, Centre Hospitalier Universitaire de Rennes, and INSERM CIC 1414, Rennes, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Pladys
authors.affiliation: Pédiatrie de Maternité, Centre Hospitalier Universitaire de Tours, Tours, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Saillant
authors.affiliation: National Institutes of Health and Medical Research, CIC 1413, and.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Legrand
authors.affiliation: EA 3628, Thérapeutiques anti infectieuses, Faculté de médecine, Université de Nantes, Nantes, France.
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Caillon
authors.affiliation: Service de Dermatologie, Centre Hospitalier Universitaire de Nantes, Nantes, France.
authors.forename: Sébastien
authors.initials: S
authors.lastname: Barbarot
authors.affiliation: Service de Pédiatrie.|National Institutes of Health and Medical Research, CIC 1413, and.
authors.forename: Jean Christophe
authors.initials: JC
authors.lastname: Roze
authors.affiliation: National Institutes of Health and Medical Research, CIC 1415, Hôpital Bretonneau, and.
authors.forename: Bruno
authors.initials: B
authors.lastname: Giraudeau
mesh_terms: D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D016000:Cluster Analysis; D018592:Cross-Over Studies; D005260:Female; D005602:France; D006801:Humans; D007224:Infant Care / Q000379:methods*; D007231:Infant, Newborn; D008297:Male; D013530:Surgical Wound Infection / Q000517:prevention & control*; D014470:Umbilical Cord / Q000187:drug effects* / Q000601:surgery*
chemical_list: D000891:Anti-Infective Agents, Local