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临床试验/NCT04270045
NCT04270045招募中不适用

Forced Oscillometry in Infants With Bronchopulmonary Dysplasia

Winston Manimtim1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Post-bronchodilator forced oscillation technique measurements (in subjects already receiving this therapy)

研究概览

简要总结

The purpose of this study is to use forced oscillometry technique (FOT) to measure pulmonary mechanics and function in in term infants and premature infants with bronchopulmonary dysplasia (BPD)

详细描述

Pulmonary function testing has been the standard of care to diagnose and evaluate response to therapy in various respiratory diseases in adults and children. There are several equipment and techniques that are FDA approved for these purposes. However, there are currently no lung function tests that are practically feasible, clinically meaningful and widely used in infants.

The forced oscillation technique (FOT) is a non-invasive method that had been used to measure respiratory mechanics. FOT employs small amplitude pressure oscillations superimposed on the normal breathing and therefore has the advantage over conventional lung function techniques that it does not require the performance of respiratory maneuvers. To date, the use of this technique is FDA approved in adults and children but remains largely experimental in infants and newborns. THORASYS has recently developed a new respiratory function test device aimed specifically at newborn and infants (0 - 2 years age group) called tremoflo N-100 ("Neo"). This new device measures lung function in only a few minutes while the newborn or infant is sleeping normally. It uses an adapted version of the Airwave Oscillometry (AOS) to calculate the impedance of the lungs and quantify airway obstruction.

Diuretics and bronchodilators are two on the most commonly used medications to ameliorate the symptoms of BPD. The benefits of these therapies have not been shown to prevent the development of BPD in a randomized control trial (RCT). More recently, there have been some evidence from pharmacogenetic studies that the variability in bronchodilator responsiveness in patients with asthma, (and possibly BPD) may lie on the gene encoding the B2-adrenergic receptor (ADRB2) as well as within the associated G-protein receptor pathway, the nitric oxide biosynthetic pathway and other novel loci identified in recent genome-wide studies. This part of the study will be hypothesis generating to try to understand the variability in bronchodilator response in infants with BPD. Normative data will be established in term neonates.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Preterm Cohort:
  • Premature infants with BPD who are in room air based on the (per NICHD definition)
  • Premature infants with BPD who are receiving low flow O2 support and able to maintain normal spO2 in Room air for brief period ( up to 3 minutes) Term Cohort without pulmonary disease
  • Infants >36 weeks gestational age without pulmonary disease
  • Infants < 4 weeks of age
  • Outpatient Cohort:
  • Former preterm infants < 32 weeks at birth
  • Those with BPD based on NIH 2001 definition
  • Seen prior to 2 years of age

排除标准

  • Infants with BPD requiring invasive or non-invasive positive pressure ventilation
  • Infants with BPD who have associated genetic diagnosis or major congenital anomalies.

结局指标

主要结局

Post-bronchodilator forced oscillation technique measurements (in subjects already receiving this therapy)

时间窗: FOT measurement 30 to 60minutes following bronchodilator therapy

FOT measurements in premature infants with BPD following bronchodilator therapy.

Forced oscillation technique measurements

时间窗: FOT measurement prior to bronchodilator therapy

Baseline FOT measurements in premature infants with BPD and term infants without pulmonary disease.

次要结局

未报告次要终点

研究者

发起方
Winston Manimtim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Winston Manimtim

Principal Investigator

Children's Mercy Hospital Kansas City

研究点 (1)

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