Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature (P3)

January 4, 2024 updated by: Robert Tepper, Indiana University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jeff Bjerregaard, RRT-NPS
  • Phone Number: 317 944 0192
  • Email: jbjerreg@iu.edu

Study Contact Backup

  • Name: Lisa Bendy, BA, RPFT
  • Phone Number: 317 278 7152
  • Email: lbendy@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Jeff Bjerregaard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 8 months (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Premature Infants
Premature infants born between 24+0 and 36+6 weeks of gestation.
Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)
Infant lung function testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant lung development measured by diffusion lung capacity (DLCO).
Time Frame: 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.
By 5 months CGA.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

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

Investigators

  • Principal Investigator: Robert Tepper, MD, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1809404763
  • 1R01HL145679-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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