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Assessment of Lung Structure and Function of Infants Born Prematurely

2020年3月3日 更新者:Robert Tepper、Indiana University School of Medicine
The purpose of this study is to evaluate the growth of the lung and how easily gas can be taken up by the lung in healthy infants born at full term without any breathing problems and infants born prematurely.

研究概览

地位

完全的

详细说明

SPECIFIC AIM #1:

Determine the relationship between parenchymal tissue and alveolar volume with normal lung growth early in life.

We hypothesize that during the first two years of life that parenchymal surface area and alveolar volume increase with somatic growth; however, the ratio of surface area to volume remains constant, while ventilation within the lung becomes more homogenous.

SPECIFIC AIM #2:

Determine the pulmonary sequelae of premature birth and assess the effectiveness of early treatment strategies upon the pulmonary sequelae.

We hypothesize that premature birth impedes growth and development of the lung parenchyma and the airways. In addition, initiating continuous positive airway pressure (CPAP) and a permissive ventilatory strategy in very premature infants at birth will improve lung growth and lung function compared to treatment with early surfactant and conventional ventilation.

研究类型

观察性的

注册 (实际的)

104

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Riley Hospital For Children

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2个月 至 3年 (孩子)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population will be selected from Infant Lung Disease Clinics at Riley Hospital, flyer in the community, and the neonatal intensive care unit (NICU) at Riley Hospial for Children, Indiana University and Methodist Hospital.

描述

Inclusion Criteria:

Group 1:

  • 37 weeks or greater gestational age
  • Age 2 to 36 months

Group 2:

  • 37 weeks or greater gestational age having a CT scan for non-respiratory issues.
  • Age 2-36 months

Group 3:

  • 23-35 weeks gestational age

Exclusion Criteria:

Group 1 and Group 2:

  • Congenital cardio-respiratory disease
  • Hospitalization for respiratory illness
  • Treatment with asthma medications
  • Small for gestational age at birth

Group 3:

  • Congenital cardio-respiratory disease
  • Severe developmental delay

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:横截面

队列和干预

团体/队列
1-Healthy Infants

Group 1: The investigators will recruit 80 healthy infants born at > 37 weeks gestation, and between 2 and 36 months of age. Infants will be excluded for any of the following reasons:

  1. Congenital cardio-respiratory disease
  2. Hospitalization for respiratory illness
  3. Treatment with asthma medications
  4. Small for gestational age at birth
2-Healthy Infants computerized Tomography

Group 2: The investigators recruited 4 infants born at > 37 weeks gestation and they were evaluated between 2 and 36 months of age when scheduled for high resolution computed tomography (HRCT) imaging for non-respiratory medical problems. Subjects were enrolled and HRCT of the chest were obtained. Infants were excluded for the following reasons:

  1. Congenital cardio-respiratory disease
  2. Hospitalization for respiratory illness
  3. Treatment with asthma medications
3-Premature Infants

Group 3: The investigators have recruited 45 infants born prematurely at 23-35 weeks gestation. Subjects were evaluated at corrected age at between 2 and 24 months. The subjects had no oxygen requirements, and were clinically stable outpatients when evaluated. Infants were excluded for any of the following reasons:

  1. Congenital cardio-respiratory disease
  2. Severe developmental delay

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pulmonary Function Testing
大体时间:day of testing
Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume
day of testing

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Robert S. Tepper, MD, PhD、Indiana University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年1月1日

初级完成 (实际的)

2019年1月1日

研究完成 (实际的)

2019年1月1日

研究注册日期

首次提交

2007年1月11日

首先提交符合 QC 标准的

2007年1月11日

首次发布 (估计)

2007年1月15日

研究记录更新

最后更新发布 (实际的)

2020年3月4日

上次提交的符合 QC 标准的更新

2020年3月3日

最后验证

2020年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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