Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

Premature Lungs Clinical Trial

— P3  

Official title:

Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03906708
• Other study ID #: 1809404763
• Secondary ID: 1R01HL145679-01A
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 249
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 36 Weeks

Eligibility

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 18.

• Non English speaking

Related Conditions & MeSH terms

• Premature Birth
• Premature Lungs

Intervention

Other:
• Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)
Infant lung function testing

Locations

Country	Name	City	State
United States	Jeff Bjerregaard	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant lung development measured by diffusion lung capacity (DLCO).	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.	By 5 months CGA.