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. Copyright 2009 S. Karger AG, Basel.
RCT Entities:
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. Copyright 2009 S. Karger AG, Basel.
Authors: Rosanna Quattrin; Kim Iacobucci; Anna Lisa De Tina; Letizia Gallina; Carla Pittini; Silvio Brusaferro Journal: Medicine (Baltimore) Date: 2016-04 Impact factor: 1.889
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
Authors: Aamer Imdad; Resti Ma M Bautista; Kathlynne Anne A Senen; Ma Esterlita V Uy; Jacinto Blas Mantaring; Zulfiqar A Bhutta Journal: Cochrane Database Syst Rev Date: 2013-05-31