Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03906708

Acronym

Enrollment

249

Registered

2019-04-08

Start date

2019-01-01

Completion date

2026-12-01

Last updated

2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Lungs

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.

Interventions

OTHERDiffusion Capacity of the Lung for Carbon Monoxide (DLCO)

Infant lung function testing

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

24 Weeks to 36 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRobert Tepper, MD

Indiana University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026