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NCT Number: NCT03906708

Physiological Phenotyping of Respiratory Outcomes in Infants Born Premature

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Premature Lungs

Age range

24 week–36 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Jeff Bjerregaard

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)

Other

Infant lung function testing

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

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

Registry information

Acronym: P3

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Apr 8, 2019
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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