OBJECTIVES: To evaluate in term babies with perinatal asphyxia, the effect of therapeutic hypothermia (TH) on oxidative stress and neurological outcome at discharge. METHODS:Babies who satisfied inclusion criteria were randomized to TH, with cooling gel packs to a target temperature of 33-34°C for 72 h or normothermia. Blood sample was collected before and after TH for oxidative stress assessment: total antioxidant status (TAS) and malondialdehyde (MDA). RESULTS: Of 116 babies randomized, there was no statistically significant difference in the baseline TAS and MDA. After 72 h of TH, TAS was significantly higher (p = <0.001) (761.69 ± 114.01 vs. 684.16 ± 88.86) and MDA was significantly lower (p = <0.001) in TH group (1.73 ± 0.66 vs. 5.2 ± 1.06). Risk of developing deficit was lower (p < 0.001) in TH group with relative risk of 0.49 and 95 % confidence interval: 0.29-0.68. CONCLUSION: TH reduces oxidative stress and improves neurological outcome in perinatal asphyxia. TRIAL REGISTRATION NUMBER: CTRI/2011/12/002196.
RCT Entities:
OBJECTIVES: To evaluate in term babies with perinatal asphyxia, the effect of therapeutic hypothermia (TH) on oxidative stress and neurological outcome at discharge. METHODS: Babies who satisfied inclusion criteria were randomized to TH, with cooling gel packs to a target temperature of 33-34°C for 72 h or normothermia. Blood sample was collected before and after TH for oxidative stress assessment: total antioxidant status (TAS) and malondialdehyde (MDA). RESULTS: Of 116 babies randomized, there was no statistically significant difference in the baseline TAS and MDA. After 72 h of TH, TAS was significantly higher (p = <0.001) (761.69 ± 114.01 vs. 684.16 ± 88.86) and MDA was significantly lower (p = <0.001) in TH group (1.73 ± 0.66 vs. 5.2 ± 1.06). Risk of developing deficit was lower (p < 0.001) in TH group with relative risk of 0.49 and 95 % confidence interval: 0.29-0.68. CONCLUSION: TH reduces oxidative stress and improves neurological outcome in perinatal asphyxia. TRIAL REGISTRATION NUMBER: CTRI/2011/12/002196.