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一项前瞻性、多中心肺高血压早产儿注册研究的实践和结果。

Practices and Outcomes from a Prospective, Multicenter Registry for Preterm Newborns with Pulmonary Hypertension.

机构信息

Department of Pediatrics, Section of Neonatology, University of Colorado School of Medicine, Aurora, CO.

Department of Pediatrics, Section of Neonatology, University of Colorado School of Medicine, Aurora, CO.

出版信息

J Pediatr. 2023 Nov;262:113614. doi: 10.1016/j.jpeds.2023.113614. Epub 2023 Jul 20.

DOI:10.1016/j.jpeds.2023.113614
PMID:37478902
Abstract

OBJECTIVE

To describe current treatment practices of preterm infants with early hypoxemic respiratory failure (HRF) and pulmonary hypertension (PH) and their association with patient outcomes.

STUDY DESIGN

We developed a prospective, observational, multicenter clinical registry of preterm newborns <34 weeks' gestation with HRF and PH, based on either clinical or echocardiographic evidence during the first 72 hours of life, from 28 neonatal intensive care units in the US from 2017 through 2022. The primary end point was mortality among those who did or did not receive PH-targeted treatment, and the secondary end points included comparisons of major morbidities. Variables were compared using t tests, Wilcoxon rank-sum tests, Fisher exact tests, and χ² tests.

RESULTS

We analyzed the results of 224 preterm infants enrolled in the registry. Of which, 84% (188/224) received PH-targeted treatment, most commonly inhaled nitric oxide (iNO). Early mortality in this cohort was high, as 33% (71/224) of this sample died in the first month of life, and 77% of survivors (105/137) developed bronchopulmonary dysplasia. Infants who received PH-targeted treatment had higher oxygenation indices at the time of enrollment (28.16 [IQR: 13.94, 42.5] vs 15.46 [IQR: 11.94, 26.15]; P = .0064). Patient outcomes did not differ between those who did or did not receive PH-targeted therapy.

CONCLUSIONS

Early-onset HRF with PH in preterm infants is associated with a high early mortality and a high risk of developing bronchopulmonary dysplasia. iNO is commonly used to treat early-onset PH in preterm infants with HRF. In comparison with untreated infants with lower oxygenation indices, iNO treatment in severe PH may prevent poorer outcomes.

摘要

目的

描述患有早期低氧性呼吸衰竭(HRF)和肺动脉高压(PH)的早产儿的当前治疗方法及其与患者结局的关系。

研究设计

我们在美国 28 个新生儿重症监护病房,于 2017 年至 2022 年期间,建立了一项针对胎龄<34 周、有 HRF 和 PH 的早产儿的前瞻性、观察性、多中心临床注册研究,依据的是出生后最初 72 小时内的临床或超声心动图证据。主要终点是接受或不接受 PH 靶向治疗的患者中的死亡率,次要终点包括主要合并症的比较。使用 t 检验、Wilcoxon 秩和检验、Fisher 确切检验和 χ²检验比较变量。

结果

我们分析了登记处纳入的 224 名早产儿的结果。其中,84%(188/224)接受了 PH 靶向治疗,最常见的是吸入性一氧化氮(iNO)。该队列的早期死亡率较高,224 例患者中 33%(71/224)在出生后的第一个月死亡,77%的幸存者(105/137)发生支气管肺发育不良。接受 PH 靶向治疗的婴儿在入组时的氧合指数更高(28.16[IQR:13.94,42.5] vs 15.46[IQR:11.94,26.15];P=0.0064)。接受或不接受 PH 靶向治疗的患者结局没有差异。

结论

早产儿早期 HRF 伴 PH 与早期死亡率高且发生支气管肺发育不良的风险高相关。iNO 常用于治疗伴有 HRF 的早产儿的早期 PH。与未接受治疗、氧合指数较低的婴儿相比,iNO 治疗严重 PH 可能预防结局较差。

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