J Pediatr. 1990 Dec;117(6):939-46. doi: 10.1016/s0022-3476(05)80142-8.
The High-Frequency Intervention Trial was a 10-center randomized clinical trial to test the efficacy and safety of high-frequency oscillatory ventilation (HFO) in the treatment of neonates weighing 750 to 2000 gm; 327 infants were assigned to HFO and 346 to conventional intermittent mechanical ventilation (IMV). Survival and lung morbidity rates were the same in the two groups. Bayley psychometric evaluations and CNS examination were performed at 16 to 24 months of postterm age in 77% of the survivors (185 HFO and 201 IMV). There was no difference in growth or respiratory status at follow-up. Cerebral palsy was diagnosed in 19 (10%) HFO-treated infants and 23 (11%) IMV-treated infants. There was no difference in severity between the two groups. A significantly higher incidence of hydrocephalus (12% vs 6%) was present in the HFO group (p less than 0.05). Bayley index scores greater than 83 were scored in 57% of HFO-treated infants compared with 66% of IMV-treated infants. The proportion of children at follow-up with a normal neuro-developmental status (i.e., Bayley score greater than 83 and no major CNS defect) was significantly less in the HFO than in the IMV group (54 vs 65%; p less than 0.05). Both treatment groups showed a strong association between the presence of grade 3 or 4 intraventricular hemorrhage and the development of major CNS or cognitive defects. No significant long-term beneficial or deleterious effects were demonstrated in the use of HFO versus IMV for the treatment of respiratory failure in low birth weight premature infants, except that there were slightly more neurologic deficits in the HFO group related to the higher proportion of survivors with major intraventricular hemorrhage.
高频干预试验是一项在10个中心开展的随机临床试验,旨在测试高频振荡通气(HFO)治疗体重750至2000克新生儿的疗效和安全性;327名婴儿被分配至HFO组,346名婴儿被分配至传统间歇性机械通气(IMV)组。两组的生存率和肺部发病率相同。77%的幸存者(185名接受HFO治疗和201名接受IMV治疗)在足月后16至24个月时进行了贝利心理测评和中枢神经系统检查。随访时,两组在生长或呼吸状况方面没有差异。19名(10%)接受HFO治疗的婴儿和23名(11%)接受IMV治疗的婴儿被诊断为脑瘫。两组在严重程度上没有差异。HFO组脑积水的发生率显著更高(12%对6%)(p<0.05)。接受HFO治疗的婴儿中有57%的贝利指数得分大于83,而接受IMV治疗的婴儿中这一比例为66%。随访时神经发育状况正常(即贝利得分大于83且无重大中枢神经系统缺陷)的儿童比例,HFO组显著低于IMV组(54%对65%;p<0.05)。两个治疗组均显示,3级或4级脑室内出血的存在与重大中枢神经系统或认知缺陷的发生之间存在密切关联。对于低出生体重早产儿呼吸衰竭的治疗,使用HFO与IMV相比,未显示出显著的长期有益或有害影响,只是HFO组的神经功能缺损略多,这与重大脑室内出血幸存者比例较高有关。