Premature LungsP3NCT03906708
Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature
An observational study of Premature Lungs, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 36 weeks
- Conditions the study is for
- Premature Lungs
- What is being tested?
- Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Recruiting infants born between 24+0 and 36+6 weeks gestational age
Who may be able to join
- Infants born to mothers who are between the gestational ages of 24+0 and 36+6 weeks.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Premature Lungs
- Being tested
- Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)Other
Infant lung function testing
| Study group | Role | What they receive |
|---|---|---|
| Premature Infants | Premature infants born between 24+0 and 36+6 weeks of gestation. Receives: Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: By 5 months CGA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Jan 2019
- Primary completion25 Jun 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature LungsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Robert Tepper, Indiana University
- Investigators
- Robert Tepper, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906708
- Sponsor's protocol ID
- 1809404763
- Other IDs
- 1R01HL145679-01A1
- Acronym
- P3
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2019
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39855623
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature
- ClinicalTrials.gov ID
- NCT03906708
- Acronym / sponsor ID
- P3 / 1809404763
- Conditions
- Premature Lungs
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature Infants | – | Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)Premature infants born between 24+0 and 36+6 weeks of gestation. |
Who may qualify
- Ages
- 24 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Recruiting infants born between 24+0 and 36+6 weeks gestational age
Key inclusion criteria (1 listed)
- Infants born to mothers who are between the gestational ages of 24+0 and 36+6 weeks.
Key exclusion criteria (8 listed)
- Cardiopulmonary defects
- Chromosomal defects
- Structural abnormalities of the upper airway, chest wall, or lungs
- Neurological/Neuromuscular disorders
- Infant not considered viable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)Infant lung function testing | Other | Premature Infants |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Derived from this study: PubMed 39855623Tepper 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.
- Individual participant dataSharing planned: Undecided
Related trials for Premature Lungs
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Physical Impairments in Premature Ventricular Complex
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Tepper, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Lungs, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant lung development measured by diffusion lung capacity (DLCO). (time frame: By 5 months CGA.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.