An interventional study of Pulmonary Function Testing and Electrocardiogram in Infant,Premature, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Other
The purpose of this research is to determine the effect of premature birth on later heart function and metabolism.
The purpose of this study is to determine the effects of premature birth on cardiac function, cardiac metabolism, and oxidative stress in a cohort of young adults born prematurely using cardiac positron emission tomography/magnetic resonance imaging and mitochondrial respiration studies.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 52 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years). All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.
Procedure: Pulmonary Function Testing · Procedure: Electrocardiogram · Procedure: Positron Emission Tomography · Procedure: Magnetic Resonance Imaging
Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.
Procedure: Pulmonary Function Testing · Procedure: Electrocardiogram · Procedure: Positron Emission Tomography · Procedure: Magnetic Resonance Imaging
Subjects will undergo Spirometry and Plethysmography
Subjects will undergo an electrocardiogram to ensure sinus rhythm
Subjects will undergo positron emission tomography to detect images of the heart
Subjects will undergo positron magnetic resonance imaging to detect images of the heart
Cardiac Glucose Uptake During Normoxic Rest (µg/Min)
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
Time frame: Visit 1 (1 day)
Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min)
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
Time frame: Visit 1 (1 day)
| Milestone | Preterm | Term - Healthy Controls |
|---|---|---|
| Started | 32 | 18 |
| Completed | 27 | 17 |
| Not completed | 5 | 1 |
| Withdrew: Bigeminy precluding hypoxia exposure | 1 | 0 |
| Withdrew: Claustrophobia from wearing the mask | 1 | 0 |
| Withdrew: Having to abruptly stop the scan to use the restroom | 2 | 0 |
| Withdrew: Image acquisition/reconstruction failure | 1 | 1 |
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
| µg/min | Preterm | Term - Healthy Controls |
|---|---|---|
| Cardiac Glucose Uptake During Normoxic Rest (µg/Min) | 0.689 ± 0.546 | 0.540 ± 0.454 |
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
| µg/min | Preterm | Term - Healthy Controls |
|---|---|---|
| Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min) | -0.264 ± 0.588 | -0.003 ± 0.390 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Preterm | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Term - Healthy Controls | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | Preterm | Term - Healthy Controls | Total |
|---|---|---|---|
| Mean | 26.1 ± 4.2 | 25.4 ± 4.0 | 25.75 ± 4.1 |
| Sex: Female, Male(Participants) | Preterm | Term - Healthy Controls | Total |
|---|---|---|---|
| Female | 23 | 10 | 33 |
| Male | 9 | 8 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Preterm | Term - Healthy Controls | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 31 | 16 | 47 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Preterm | Term - Healthy Controls | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 30 | 16 | 46 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Gestational age (Neonatal Characteristics)(Weeks) | Preterm | Term - Healthy Controls | Total |
|---|---|---|---|
| Mean | 29.2 ± 2.5 | 39.8 ± 1.0 | 34.5 ± 1.75 |
| Birth weight (Neonatal Characteristics)(Grams) | Preterm | Term - Healthy Controls | Total |
|---|---|---|---|
| Mean | 1225 ± 397 | 3397 ± 572 | 2311 ± 484.5 |
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Plan to share: No
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University of Wisconsin, Madison