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临床试验/NCT04941963
NCT04941963已完成不适用

Functional Evaluation of the Diaphragm With Bedside Ultrasound in Infants With Bronchopulmonary Dysplasia: a Single Centre Prospective Trial

Mount Sinai Hospital, Canada1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Evaluation of the diaphragmatic Thickness fraction and diaphragmatic excursion in neonates with bronchopulmonary dysplasia

研究概览

简要总结

Preterm infants have high and prolonged exposure to positive pressure ventilation, which contributes to acute lung injury and the development of bronchopulmonary dysplasia (BPD). Despite the risk of diaphragmatic dysfunction in infants with BPD, the effect of prolonged ventilator support on the diaphragmatic function of preterm infants has not been well characterized.

Hence, we aim to characterize the diaphragmatic function of very preterm neonates with BPD who are corrected to ≥ 36 weeks using bedside ultrasound in comparison to healthy newborns born at ≥ 36 weeks gestation.

详细描述

Study Design and setting; This is a prospective descriptive pilot study that will be conducted on infants born at ≤ 32 weeks gestation who meet eligibility criteria and are admitted to the neonatal intensive care at Mount Sinai Hospital and healthy newborns born at at ≥ 36 weeks gestation. Enrollment of eligible infants will start after obtaining approval from the Research Ethics Board at Mount Sinai Hospital and parental consent.

Time of assessment; Parents of infants who are eligible for the study will be approached for consent. Chest ultrasound (lung ultrasound and diaphragmatic function assessment) will be performed at ≥ 36 weeks corrected gestational age. Chest ultrasound will be done before a feeding to avoid any concerns of a full stomach on diaphragmatic assessment.

Study procedure; Functional assessment of the diaphragm will be done by two of the investigators. Standard variables for assessing diaphragm function will be used including diaphragmatic thickness, diaphragmatic thickness fraction, and diaphragmatic excursion (DE). Diaphragmatic thickness fraction, and diaphragmatic excursion will be calculated. Inter-rater agreement will be assessed using raw percentage of agreement (Pa), Cohen's and Kappa (κ), and G wet agreement coefficient (AC1). Intra-class correlation (ICC) will be determined for variables with continuous measurements (mixed factorial design). High-resolution linear and curvilinear US probes of 20-5 and 10-3 MegahertZ will be used to measure diaphragmatic thickness fraction, and diaphragmatic excursion [amplitude] respectively using both B and M modes.

Diaphragmatic assessment technique; Diaphragm assessment will be performed in the supine position. To measure diaphragmatic excursion, the curvilinear probe will be placed on the lower intercostal spaces between the mid-clavicular and anterior axillary lines on the right side. Using the B mode, the proper exploration line of the diaphragm will be detected by directing the beam perpendicular to the posterior third of the right hemidiaphragm. By M mode, the cyclic caudal diaphragmatic displacement with respiration will be measured as the perpendicular distance between the most caudal point of the liver or spleen at the end of expiration and the end of inspiration. The average of three respiratory cycles will be taken.

The assessment of the diaphragmatic efficiency as a pressure generator will be evaluated using the diaphragmatic thickness fraction. Diaphragmatic thickness will be measured at the apposition zone which can be obtained by placing the linear transducer above the 10th rib in the mid-axillary or anterior axillary lines in the right intercostal spaces. By B mode, three distinct layers will be seen, the diaphragm as a hypo-echoic area bordered by two clear echogenic lines of the pleural membrane (upper line) and the peritoneal membrane (lower line). Using M-mode tracing, inspiratory diaphragmatic thickness will be measured as the maximum perpendicular distance between pleural and peritoneal layers and by the same way expiratory diaphragmatic thickness will be recorded. diaphragmatic thickness fraction will be calculated using the following formula:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
36 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Infants who are born at ≤ 32 weeks gestation,
  • Admitted to the neonatal intensive care at Mount Sinai Hospital
  • Receiving oxygen or respiratory support at ≥ 36 weeks gestation
  • Infants who are born at ≥ 36 weeks gestation
  • Admitted to the level 1 nursery.
  • Informed consent obtained from parents or guardians prior to enrolment in the study.

排除标准

  • Infants who have congenital or chromosomal abnormalities.
  • Parents declined the consent.

结局指标

主要结局

Evaluation of the diaphragmatic Thickness fraction and diaphragmatic excursion in neonates with bronchopulmonary dysplasia

时间窗: 1 year

* Chest ultrasound will be used to evaluate the diaphragmatic function in neonates at ≥ 36 weeks gestation with bronchopulmonary dysplasia in comparison to diaphragmatic function in healthy newborns born at ≥ 36 weeks gestation. * Assessment of Diaphragmatic Thickness in millimetres. * Assessment of Diaphragmatic Excursion in millimetres.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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