Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature (P3)
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ClinicalTrials.gov Identifier: NCT03906708 |
Recruitment Status :
Recruiting
First Posted : April 8, 2019
Last Update Posted : January 21, 2022
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Condition or disease | Intervention/treatment |
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Premature Lungs | Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) |
Study Type : | Observational |
Estimated Enrollment : | 225 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature |
Actual Study Start Date : | January 1, 2019 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | January 2024 |
Group/Cohort | Intervention/treatment |
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Premature Infants
Premature infants born between 24+0 and 36+6 weeks of gestation.
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Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)
Infant lung function testing |
- 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 24 Weeks to 36 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906708
Contact: Jeff Bjerregaard, RRT-NPS | 317 944 0192 | jbjerreg@iu.edu | |
Contact: Lisa Bendy, BA, RPFT | 317 278 7152 | lbendy@iu.edu |
United States, Indiana | |
Jeff Bjerregaard | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Jeff Bjerregaard, RRT-NPS 317-944-0192 jbjerreg@iu.edu | |
Contact: Christina Tiller, RRT-CCRC 317 944 4522 ctiller@iu.edu |
Principal Investigator: | Robert Tepper, MD | Indiana University School of Medicine |
Responsible Party: | Robert Tepper, Professor of Pediatrics, MD, PhD, Indiana University |
ClinicalTrials.gov Identifier: | NCT03906708 |
Other Study ID Numbers: |
1809404763 1R01HL145679-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | April 8, 2019 Key Record Dates |
Last Update Posted: | January 21, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Carbon Monoxide |
Antimetabolites Molecular Mechanisms of Pharmacological Action Gasotransmitters Neurotransmitter Agents Physiological Effects of Drugs |