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临床试验/NCT02996162
NCT02996162撤回不适用

The Natural Course of Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease

Boston Children's Hospital1 个研究点 分布在 1 个国家开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Respiratory symptoms and complications

研究概览

简要总结

This is a prospective, longitudinal observational study to provide data regarding the natural course of hypercapnia in premature infants with bronchopulmonary dysplasia using both available blood pCO2 and measured capnography, as well as relate the degree and trend of hypercapnia to later respiratory outcomes.

详细描述

Data collection will begin once an infant no longer requires mechanical ventilation, CPAP, and HFNC, up to twice per week while in the NICU. Investigators will obtain up to twenty minutes of end-tidal capnography data, using Masimo ISA modules with continuous CO2 display. Five minutes of good quality data, at approximately 30 breaths per minutes, should provide approximately 150 data points. After filtering for artifact, the mean and range of end tidal CO2 will be recorded during this interval. These recordings will be started after a feed for infants receiving enteral feeds. The capnography cannula will be placed by the bedside nurse or respiratory therapist at the conclusion of a feed and removed no later than the next feed. If data is unable to be obtained, investigators will attempt to collect it at the next regularly scheduled interval.

Available blood gases with pCO2 will also be recorded during the NICU hospitalization.

After discharge, consented subjects who are followed in the BCH outpatient pulmonary clinic will have capnography recorded at every clinic visit for a period of up to twenty minutes, and mean and range of end-tidal CO2 will be recorded after filtering for artifact. Available blood gases with pCO2 during pulmonary visits will be recorded; blood gases during sick encounters (i.e. emergency room) will be excluded. From available electronic medical record (EMR) and clinic note data, investigators will also record duration of time on respiratory support including positive pressure ventilation and nasal cannula oxygen.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
3 Days 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Potential eligible patients will be identified in the first 3-14 days of life at Beth Israel Deaconess Hospital (BIDMC) NICU who have a birth gestational age <=32 0/7 weeks and current or previous requirement for positive pressure (ventilation or continuous positive airway pressure (CPAP).

排除标准

  • death prior to discharge from the NICU,
  • chronic lung disease secondary to pulmonary conditions other than bronchopulmonary dysplasia and
  • other underlying identified genetic syndromes.

结局指标

主要结局

Respiratory symptoms and complications

时间窗: One year

Primary outcome will be respiratory symptoms at one year. Respiratory symptoms will be measured by a parent-reported respiratory symptom score obtained via questionnaire.

次要结局

  • Respiratory support(One year)
  • Non-respiratory complications(One year)
  • Respiratory complications(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristen Leeman

MD

Boston Children's Hospital

研究点 (1)

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