Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature
Overview
- Phase
- Not Applicable
- Intervention
- Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)
- Conditions
- Premature Lungs
- Sponsor
- Indiana University
- Enrollment
- 249
- Locations
- 1
- Primary Endpoint
- Infant lung development measured by diffusion lung capacity (DLCO).
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Robert Tepper
Professor of Pediatrics, MD, PhD
Indiana University
Eligibility Criteria
Inclusion Criteria
- •Infants born to mothers who are between the gestational ages of 24+0 and 36+6 weeks.
Exclusion Criteria
- •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
Arms & Interventions
Premature Infants
Premature infants born between 24+0 and 36+6 weeks of gestation.
Intervention: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)
Outcomes
Primary Outcomes
Infant lung development measured by diffusion lung capacity (DLCO).
Time Frame: 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.