Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

Active, not recruiting

• Conditions: Premature Lungs
• Interventions: Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)

• Registration Number: NCT03906708
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

• Infants born to mothers who are between the gestational ages of 24+0 and 36+6 weeks.

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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 18.
• Non English speaking

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Premature Infants	Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)	Premature infants born between 24+0 and 36+6 weeks of gestation.

Primary Outcome Measures

Name	Time	Method
Infant lung development measured by diffusion lung capacity (DLCO).	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.

Trial Locations

Locations (1)

Jeff Bjerregaard; 🇺🇸 Indianapolis, Indiana, United States