Outcome at 2 years of age of infants from the DART study: a multicenter, international, randomized, controlled trial of low-dose dexamethasone
Outcome at 2 years of age of infants from the DART study: a multicenter, international, randomized, controlled trial of low-dose dexamethasone
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DOI：
10.1542/peds.2006-2806
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发表时间：
2007-04-01
期刊：
影响因子：
8
通讯作者：
Carlin, John B.
中科院分区：
文献类型：
--
作者：
Doyle, Lex W.;Davis, Peter G.;Carlin, John B.
OBJECTIVE.低剂量地塞米松有助于无明显短期并发症的慢性呼吸机依赖婴儿的拔管。本研究的目的是确定低剂量地塞米松的长期影响。极早产（< 28周妊娠）或极低出生体重（出生体重< 1000 g）婴儿，出生后第一周后依赖呼吸机，临床医生认为需要皮质类固醇。在知情同意后，婴儿被随机分配到盲态地塞米松（0.89 mg/kg，持续10天）或生理盐水安慰剂组。由不知道治疗组分配的工作人员在2岁校正年龄时评估存活者，以确定神经感觉结局、生长和健康状况。由于招募困难，该试验被放弃，远远低于其目标样本量。从11个中心招募了70名婴儿，每组35名：59名存活至2岁，58名（98%）在随访时进行了评估，但只有56名幸存者的脑瘫数据可用。几乎没有证据表明主要终点、死亡或2岁时严重残疾的联合结局发生率存在差异（地塞米松组：46%;对照组：43%）。随访前死亡率（11% vs 20%）、严重残疾率（41% vs 31%）、脑瘫率（14% vs 22%）或死亡或脑瘫的联合结局率（23% vs 37%）在两组之间没有显著差异。小剂量地塞米松对生长发育及出院后再入院无明显影响。虽然这项试验不能提供明确的证据，低剂量地塞米松的长期影响后，第一周的生活在慢性呼吸机依赖的婴儿，我们的数据表明，没有强烈的相关性与长期发病率。
OBJECTIVE. Low-dose dexamethasone facilitates extubation in chronically ventilator-dependent infants with no obvious short-term complications. The objective of this study was to determine the long-term effects of low-dose dexamethasone.METHODS. Very preterm (< 28 weeks' gestation) or extremely low birth weight (birth weight < 1000 g) infants who were ventilator dependent after the first week of life for whom clinicians considered corticosteroids were indicated were eligible. After informed consent, infants were randomly assigned to masked dexamethasone (0.89 mg/kg over 10 days) or saline placebo. Survivors were assessed at 2 years' corrected age by staff blinded to treatment group allocation to determine neurosensory outcome, growth, and health.RESULTS. The trial was abandoned well short of its target sample size because of recruitment difficulties. Seventy infants were recruited from 11 centers, 35 in each group: 59 survived to 2 years of age, and 58 (98%) were assessed at follow-up, but data for cerebral palsy were available for only 56 survivors. There was little evidence for a difference in the major end point, the rate of the combined outcome of death, or major disability at 2 years of age ( dexamethasone group: 46%; controls: 43%). Rates of mortality before follow-up (11% vs 20%), major disability (41% vs 31%), cerebral palsy (14% vs 22%), or of the combined outcomes of death or cerebral palsy (23% vs 37%) were not substantially different between the groups. There were no obvious effects of low-dose dexamethasone on growth or readmissions to hospital after discharge.CONCLUSIONS. Although this trial was not able to provide definitive evidence on the long-term effects of low-dose dexamethasone after the first week of life in chronically ventilator-dependent infants, our data indicate no strong association with long-term morbidity.