Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Infant lung development measured by diffusion lung capacity (DLCO).
研究概览
简要总结
The purpose of this study is to examine if infants are more likely to suffer from respiratory complications during their first year of life due to being born premature.
详细描述
The overall objective of this study is to determine if infant respiratory morbidities after preterm birth are highly variable due to differential impairment of airway, parenchymal and vascular development that can be characterized as distinct physiologic phenotypes. If the nature and severity of these specific impairments of lung function are strongly associated with increased respiratory morbidities during infancy and that proteomic biomarkers can enhance the physiologic characterization of phenotype and prediction of late respiratory outcomes.
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
- 24 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born to mothers who are between the gestational ages of 24+0 and 36+6 weeks.
排除标准
- •Cardiopulmonary defects
- •Chromosomal defects
- •Structural abnormalities of the upper airway, chest wall, or lungs
- •Neurological/Neuromuscular disorders
- •Infant not considered viable
- •Family unlikely to be available for long term follow up
- •Mothers under the age of
- •Non English speaking
研究组 & 干预措施
Premature Infants
Premature infants born between 24+0 and 36+6 weeks of gestation.
干预措施: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) (Other)
结局指标
主要结局
Infant lung development measured by diffusion lung capacity (DLCO).
时间窗: By 5 months CGA.
To characterize respiratory phenotypes through specific physiologic measures that quantify and identify predominant small airways, parenchymal and vascular dysfunction at 4 months CA and determine whether these phenotypes define risks for late respiratory morbidity during infancy.
次要结局
未报告次要终点
研究者
Robert Tepper
Professor of Pediatrics, MD, PhD
Indiana University