Pediatric Radiology, Hôpital Universitaire Robert Debré, Paris, France.
Neonatal Intensive Care Unit, Hopital Universitaire Robert Debre, Paris, Île-de-France, France.
Arch Dis Child Fetal Neonatal Ed. 2020 Sep;105(5):520-525. doi: 10.1136/archdischild-2019-317720. Epub 2020 Jan 24.
To determine whether early low-dose hydrocortisone treatment in extremely preterm infants is associated with brain damage assessed by MRI at term equivalent of age (TEA).
This is a predefined secondary analysis of brain abnormalities, observed by MRI at TEA, of patients randomly assigned to receive either placebo or hydrocortisone in the PREMILOC trial. Outcomes were based on brain abnormalities graded according to Kidokoro scores.
Among 412 survivors at TEA, 300 MRIs were performed and 295 were suitable for analysis. Kidokoro scoring was completed for 119/148 and 110/147 MRIs in the hydrocortisone and placebo groups, respectively. The distribution of the Kidokoro white matter (WM) subscore and other subscores was not significantly different between the two groups. There was, however, a significant association between a higher overall Kidokoro score and hydrocortisone treatment (5.84 (SD 3.51) for hydrocortisone and 4.98 (SD 2.52) for placebo; mean difference, 0.86; 95% CI 0.06 to 1.66; p=0.04). However, hydrocortisone was not statistically associated with moderate-to-severe brain lesions (Kidokoro overall score ≥6) in a multivariate logistic regression model accounting for potential confounding variables (adjusted OR (95% CI) 1.27 (0.75 to 2.14), p=0.38). Bronchopulmonary dysplasia at 36 weeks postmenstrual age significantly predicted both WM damage (adjusted OR (95% CI) 2.70 (1.03 to 7.14), p=0.04) and global brain damage (adjusted OR (95% CI) 2.18 (1.19 to 3.99), p=0.01).
Early hydrocortisone exposure in extremely preterm infants is not statistically associated with either WM brain damage or overall moderate-to-severe brain lesions when adjusted for other neonatal variables.
EudraCT number 2007-002041-20, NCT00623740.
确定极低出生体重儿早期小剂量氢化可的松治疗是否与胎龄相当于足月（TEA）时 MRI 评估的脑损伤有关。
这是 PREMILOC 试验中随机分配接受安慰剂或氢化可的松的患者在 TEA 时通过 MRI 观察到的脑异常的预先设定的次要分析。结果基于根据 Kidokoro 评分分级的脑异常。
在 TEA 时存活的 412 名患者中，进行了 300 次 MRI 检查，其中 295 次适合分析。在氢化可的松组和安慰剂组中，分别完成了 119/148 和 110/147 次 MRI 的 Kidokoro 评分。两组之间 Kidokoro 白质（WM）子评分和其他子评分的分布无显著差异。然而，较高的总体 Kidokoro 评分与氢化可的松治疗之间存在显著关联（氢化可的松为 5.84（SD 3.51），安慰剂为 4.98（SD 2.52）；平均差异，0.86；95%CI 0.06 至 1.66；p=0.04）。然而，在考虑潜在混杂变量的多变量逻辑回归模型中，氢化可的松与中度至重度脑损伤（Kidokoro 总评分≥6）并无统计学关联（调整后的 OR（95%CI）1.27（0.75 至 2.14），p=0.38）。36 周龄时的支气管肺发育不良显著预测 WM 损伤（调整后的 OR（95%CI）2.70（1.03 至 7.14），p=0.04）和整体脑损伤（调整后的 OR（95%CI）2.18（1.19 至 3.99），p=0.01）。
在调整其他新生儿变量后，极低出生体重儿早期暴露于氢化可的松与 WM 脑损伤或总体中度至重度脑损伤均无统计学关联。
EudraCT 编号 2007-002041-20，NCT00623740。
