Pediatrics international : official journal of the Japan Pediatric Society · 2016
Comparison of selective head cooling versus whole-body cooling.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Celik Yalcın, Atıcı Aytug, Gulası Selvi, Okuyaz Cetin, Makharoblıdze Khatuna, Sungur Mehmet Ali
Аннотация
BACKGROUND: This study compared selective head cooling (SHC) and whole-body cooling (WBC) in newborns with hypoxic-ischemic encephalopathy (HIE).
METHODS: We conducted a prospective randomized small-scale pilot study in newborns with HIE, born after >35 weeks of gestation. The patients were randomly assigned to receive SHC or WBC.
RESULTS: The SHC group consisted of 17 patients, and the WBC group, 12 patients. There was no significant difference in adverse effects related to cooling therapy between the two groups. During the 12 month study period, seven patients in the SHC group and four in the WBC group died, but the difference was not significant (P = 0.667). Among the patients alive at 12 months after treatment, six in the SHC group and four in the WBC group had severe disabilities; the difference was not significant (P = 0.671). When the composite outcome of death or severe disability was evaluated, the difference between the SHC group (77%, n = 13) and the WBC group (67%, n = 8) was not significant (P = 0.562). Moreover, the number of survivors without disability at 12 months after treatment did not differ significantly between the SHC group (n = 3) and the WBC group (n = 4; P = 0.614).
CONCLUSIONS: There were no significant differences in adverse effects, 12 month neuromotor development, or mortality rate between SHC and WBC in newborns with HIE, born after >35 weeks of gestation.
METHODS: We conducted a prospective randomized small-scale pilot study in newborns with HIE, born after >35 weeks of gestation. The patients were randomly assigned to receive SHC or WBC.
RESULTS: The SHC group consisted of 17 patients, and the WBC group, 12 patients. There was no significant difference in adverse effects related to cooling therapy between the two groups. During the 12 month study period, seven patients in the SHC group and four in the WBC group died, but the difference was not significant (P = 0.667). Among the patients alive at 12 months after treatment, six in the SHC group and four in the WBC group had severe disabilities; the difference was not significant (P = 0.671). When the composite outcome of death or severe disability was evaluated, the difference between the SHC group (77%, n = 13) and the WBC group (67%, n = 8) was not significant (P = 0.562). Moreover, the number of survivors without disability at 12 months after treatment did not differ significantly between the SHC group (n = 3) and the WBC group (n = 4; P = 0.614).
CONCLUSIONS: There were no significant differences in adverse effects, 12 month neuromotor development, or mortality rate between SHC and WBC in newborns with HIE, born after >35 weeks of gestation.