Steer P, Flenady V, Shearman A, Charles B, Gray P H, Henderson-Smart D, Bury G, Fraser S, Hegarty J, Rogers Y, Reid S, Horton L, Charlton M, Jacklin R, Walsh A
Department of Neonatology and Centre for Clinical Studies, University of Queensland, Mater Health Services, South Brisbane, Australia.
Arch Dis Child Fetal Neonatal Ed. 2004 Nov;89(6):F499-503. doi: 10.1136/adc.2002.023432.
To compare two dosing regimens for caffeine citrate in the periextubation period for neonates born at less than 30 weeks gestation in terms of successful extubation and adverse effects.
A multicentre, randomised, double blind, clinical trial.
Four tertiary neonatal units within Australia.
Infants born less than 30 weeks gestation ventilated for more than 48 hours.
Two dosing regimens of caffeine citrate (20 v 5 mg/kg/day) for periextubation management. Treatment started 24 hours before a planned extubation or within six hours of an unplanned extubation.
Failure to extubate within 48 hours of caffeine loading or reintubation and ventilation or doxapram within seven days of caffeine loading.
A total of 234 neonates were enrolled. A significant reduction in failure to extubate was shown for the 20 mg/kg/day dosing group (15.0% v 29.8%; relative risk 0.51; 95% confidence interval (CI) 0.31 to 0.85; number needed to treat 7 (95% CI 4 to 24)). A significant difference in duration of mechanical ventilation was shown for infants of less than 28 weeks gestation receiving the high dose of caffeine (mean (SD) days 14.4 (11.1) v 22.1 (17.1); p = 0.01). No difference in adverse effects was detected in terms of mortality, major neonatal morbidity, death, or severe disability or general quotient at 12 months.
This trial shows short term benefits for a 20 mg/kg/day dosing regimen of caffeine citrate for neonates born at less than 30 weeks gestation in the periextubation period, without evidence of harm in the first year of life.
比较枸橼酸咖啡因两种给药方案用于孕周小于30周的新生儿拔管期的拔管成功率及不良反应。
多中心、随机、双盲临床试验。
澳大利亚的四个三级新生儿重症监护病房。
孕周小于30周且机械通气超过48小时的婴儿。
枸橼酸咖啡因两种给药方案（20对比5mg/kg/天）用于拔管期管理。在计划拔管前24小时或非计划拔管后6小时内开始治疗。
咖啡因负荷后48小时内未能成功拔管或在咖啡因负荷后7天内再次插管、通气或使用多沙普仑。
共纳入234例新生儿。20mg/kg/天给药组拔管失败率显著降低（15.0%对比29.8%；相对危险度0.51；95%置信区间（CI）0.31至0.85；需治疗人数7（95%CI 4至24））。接受高剂量咖啡因的孕周小于28周的婴儿机械通气时间有显著差异（平均（标准差）天数14.4（11.1）对比22.1（17.1）；p = 0.01）。在死亡率、主要新生儿发病率、死亡、严重残疾或12个月时的综合发育商方面，未检测到不良反应有差异。
本试验表明，孕周小于30周的新生儿在拔管期采用20mg/kg/天的枸橼酸咖啡因给药方案有短期益处，且在生命的第一年没有伤害证据。
