NCT03906708

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jan 2019Dec 2026

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

5.5 years

First QC Date

March 18, 2019

Last Update Submit

February 17, 2026

Conditions

Premature Lungs

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

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

Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)OTHER

Infant lung function testing

Premature Infants

Eligibility Criteria

Age24 Weeks - 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeff Bjerregaard

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Proteomics analysis

MeSH Terms

Interventions

Carbon Monoxide

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen Compounds

Study Officials

  • Robert Tepper, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics, MD, PhD

Study Record Dates

First Submitted

March 18, 2019

First Posted

April 8, 2019

Study Start

January 1, 2019

Primary Completion

June 25, 2024

Study Completion (Estimated)

December 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

US(1)