Christèle Gras-Le Guen1,2,3, Agnès Caille4, Elise Launay5,2, Cécile Boscher5,2, Nathalie Godon5, Christophe Savagner6, Emmanuelle Descombes7, Gisèle Gremmo-Feger8, Patrick Pladys9, Dominique Saillant10, Arnaud Legrand2, Jocelyne Caillon3, Sébastien Barbarot11, Jean Christophe Roze5,2, Bruno Giraudeau4. 1. Service de Pédiatrie, christele.grasleguen@chu-nantes.fr. 2. National Institutes of Health and Medical Research, CIC 1413, and. 3. EA 3628, Thérapeutiques anti infectieuses, Faculté de médecine, Université de Nantes, Nantes, France. 4. National Institutes of Health and Medical Research, CIC 1415, Hôpital Bretonneau, and. 5. Service de Pédiatrie. 6. Pédiatrie de Maternité, Centre Hospitalier Universitaire d'Angers, Angers, France. 7. Pédiatrie de Maternité, Centre Hospitalier Universitaire de Poitiers, Poitiers, France. 8. Pédiatrie de Maternité, Centre Hospitalier Universitaire Brest, Brest France; and. 9. Service de pédiatrie-néonatologie et maternité, Centre Hospitalier Universitaire de Rennes, and INSERM CIC 1414, Rennes, France. 10. Pédiatrie de Maternité, Centre Hospitalier Universitaire de Tours, Tours, France. 11. Service de Dermatologie, Centre Hospitalier Universitaire de Nantes, Nantes, France.
Abstract
BACKGROUND AND OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND AND OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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: María Dolores López-Medina; Ana Belén López-Araque; Manuel Linares-Abad; Isabel María López-Medina Journal: PLoS One Date: 2020-01-10 Impact factor: 3.240