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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 : April 16, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert Tepper, Indiana University

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Premature Lungs Other: Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)

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
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Study Type : Observational
Estimated Enrollment : 150 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
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Proteomics analysis

Eligibility Criteria
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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
Study Population
Recruiting infants born between 24+0 and 36+6 weeks gestational age
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Marylyn Robinson, RN, BSN 317 944 0192 mr13@iu.edu
Contact: Katia Rothhaar, PhD, MBA 317 944 3201 krothhaa@iu.edu

Locations
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United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Marylyn Robinson, RN,BSN         
Sponsors and Collaborators
Indiana University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Responsible Party: Robert Tepper, Professor of Pediatrics, MD, PhD, Indiana University
ClinicalTrials.gov Identifier: NCT03906708     History of Changes
Other Study ID Numbers: 1809404763
1R01HL145679-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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