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一项在早产儿中获取脉冲振荡法数据的多中心方案的设计与实施。

Design and implementation of a multicenter protocol to obtain impulse oscillometry data in preterm children.

作者信息

Tsukahara Katharine, Ren Clement L, Allen Julian, Bann Carla, McDonough Joseph, Ziolkowski Kristina, Clem Charles C, DeMauro Sara B

机构信息

Division of Pulmonary and Sleep Medicine, Department of Pediatrics Children's Hospital of Philadelphia Philadelphia Pennsylvania USA.

Division of Statistical and Data Sciences RTI International Research Triangle Park North Carolina USA.

出版信息

Pediatr Investig. 2024 Sep 25;8(4):253-264. doi: 10.1002/ped4.12450. eCollection 2024 Dec.

Abstract

IMPORTANCE

Objective measures of lung function are critical for assessing respiratory outcomes of prematurity. Among extremely low gestational age neonates (ELGANs) (< 29 weeks gestational age), high rates of neurodevelopmental impairment may interfere with lung function testing. Impulse oscillometry (IOS) is a noninvasive test of respiratory system mechanics not requiring forced expiration.

OBJECTIVE

To describe a multicenter study design for respiratory follow-up testing in a cohort with a high rate of extreme prematurity.

METHODS

School-age children enrolled in two prior trials of ELGANs and term controls were assessed by IOS at five centers. Groups consisted of children with prematurity with a high incidence of bronchopulmonary dysplasia, children with prematurity with no or minimal lung disease, and healthy term children. A rigorous centralized review process reviewed IOS studies for technical acceptability. Approach to design and implementation, rates of feasibility and success, and characteristics of participants are described.

RESULTS

A total of 243 children were recruited, of whom 239 (98%) attempted oscillometry. There were high rates of technical acceptability across all three cohorts (85%-90% of attempted tests), and across all five centers (80%-94% of attempted tests). Respiratory and neuromotor clinical factors associated with testing failure included a higher number of days on ventilation during neonatal intensive care, a history of intraventricular hemorrhage grade 3 or 4, and gross motor functional impairment.

INTERPRETATION

We report high rates of feasibility and success of oscillometry in a large multicenter ELGAN population, in whom neurological and developmental comorbidities likely play a confounding role.

摘要

重要性

肺功能的客观测量对于评估早产的呼吸结局至关重要。在极早产儿(孕周<29周)中,高比例的神经发育障碍可能会干扰肺功能测试。脉冲振荡法(IOS)是一种呼吸系统力学的非侵入性测试,不需要用力呼气。

目的

描述一项针对极早产发生率高的队列进行呼吸随访测试的多中心研究设计。

方法

在五个中心,对参加过两项极早产儿和足月儿对照先前试验的学龄儿童进行IOS评估。分组包括支气管肺发育不良发生率高的早产儿、无或仅有轻微肺部疾病的早产儿以及健康足月儿。一个严格的集中审查过程对IOS研究的技术可接受性进行审查。描述了设计和实施方法、可行性和成功率以及参与者的特征。

结果

共招募了243名儿童,其中239名(98%)尝试了振荡法测试。在所有三个队列中(85%-90%的尝试测试)以及所有五个中心(80%-94%的尝试测试),技术可接受率都很高。与测试失败相关的呼吸和神经运动临床因素包括新生儿重症监护期间通气天数较多、3级或4级脑室内出血病史以及粗大运动功能障碍。

解读

我们报告了在一个大型多中心极早产儿群体中振荡法测试的高可行性和成功率,在该群体中神经和发育合并症可能起混杂作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d91f/11664534/96a76968b6d3/PED4-8-253-g002.jpg

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