Physiological Phenotyping of Respiratory Outcomes in Infa... | NCT03906708

Studies
Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

NCT03906708

Sponsor

Indiana University

Status

Active, not recruiting

Last Update Posted

Feb 19, 2026Actual

Enrollment

249Actual

Phase

Not provided

Conditions

Premature Lungs

Interventions

Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01HL145679-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jun 25, 2024Actual

Completion Date

Dec 2026Estimated

First Submitted Date

Mar 18, 2019

First Submission Date that Met QC Criteria

Apr 4, 2019

First Posted Date

Apr 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2026

Last Update Posted Date

Feb 19, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Tepper, Professor of Pediatrics, MD, PhD, Indiana UniversityPrincipal Investigator

Lead Sponsor

Indiana UniversityOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

249Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)	Other	Infant lung function testing	Premature Infants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 18.
Non English speaking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Weeks

Maximum Age

36 Weeks

Standard Ages

Child

Study Population

Recruiting infants born between 24+0 and 36+6 weeks gestational age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Tepper, MD	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jeff Bjerregaard		Indianapolis	Indiana	46202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39855623	Derived	Tepper RS, Wagner BD, Bjerregaard J, Tiller C, Amos L, Sokol G, Adducci D, Abman SH. Physiologic Pulmonary Phenotyping of Infants Born Preterm and Post-Discharge Respiratory Morbidity. J Pediatr. 2025 Apr;279:114475. doi: 10.1016/j.jpeds.2025.114475. Epub 2025 Jan 22.

ID	Term
D017554	Carbon Compounds, Inorganic
D007287	Inorganic Chemicals
D005740	Gases
D010087	Oxides