Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

NCT ID: NCT03906708

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Premature Lungs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Premature Infants

Premature infants born between 24+0 and 36+6 weeks of gestation.

Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)

Intervention Type OTHER

Infant lung function testing

Interventions

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Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)

Infant lung function testing

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Robert Tepper

Professor of Pediatrics, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Tepper, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Jeff Bjerregaard

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1809404763

Identifier Type: -

Identifier Source: org_study_id

1R01HL145679-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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