Infant,Premature
Conditions
Keywords
premature adults, premature, premature lung function, premature cardiac function, MRI, PET
Brief summary
The purpose of this research is to determine the effect of premature birth on later heart function and metabolism.
Detailed description
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.
Interventions
PROCEDUREPulmonary Function Testing
Subjects will undergo Spirometry and Plethysmography
PROCEDUREElectrocardiogram
Subjects will undergo an electrocardiogram to ensure sinus rhythm
PROCEDUREPositron Emission Tomography
Subjects will undergo positron emission tomography to detect images of the heart
PROCEDUREMagnetic Resonance Imaging
Subjects will undergo positron magnetic resonance imaging to detect images of the heart
Sponsors
National Institutes of Health (NIH)
American Heart Association
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Young adults born premature (some of them are registered on the National Lung Project) and Healthy Controls will undergo pulmonary function testing, cardiac positron emission tomography, and cardiac magnetic resonance imaging.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* National Lung Project Cohort only- birth weight \<1500g and a gestational age \<36 weeks * Adults born preterm (Non-National Lung Project) only- gestational age ≤32 weeks OR birth weight ≤ 3lbs 5oz * Healthy Controls only- No personal history of known cardiovascular or pulmonary disease
Exclusion criteria
* Metabolic Disorders that would affect Fludeoxyglucose uptake * Contraindications to positron emission tomography and/or magnetic resonance imaging * Pregnancy, if a female of child-bearing potential * A personal history of Type I or Type II diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Glucose Uptake During Normoxic Rest (µg/Min) | Visit 1 (1 day) | Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI. |
| Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min) | Visit 1 (1 day) | Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI. |
Countries
United States
Participant flow
Pre-assignment details
Out of 52 enrolled participants, no data was collected for 2 participants due to COVID. 50 participants were allocated to intervention.
Participants by arm
| Arm | Count |
|---|---|
| Preterm 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.
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart | 32 |
| Term - Healthy Controls 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.
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart | 18 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Bigeminy precluding hypoxia exposure | 1 | 0 |
| Overall Study | Claustrophobia from wearing the mask | 1 | 0 |
| Overall Study | Having to abruptly stop the scan to use the restroom | 2 | 0 |
| Overall Study | Image acquisition/reconstruction failure | 1 | 1 |
Baseline characteristics
| Characteristic | Preterm | Total | Term - Healthy Controls |
|---|---|---|---|
| Age, Continuous | 26.1 years STANDARD_DEVIATION 4.2 | 25.75 years STANDARD_DEVIATION 4.1 | 25.4 years STANDARD_DEVIATION 4 |
| Birth weight (Neonatal Characteristics) | 1225 Grams STANDARD_DEVIATION 397 | 2311 Grams STANDARD_DEVIATION 484.5 | 3397 Grams STANDARD_DEVIATION 572 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 47 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational age (Neonatal Characteristics) | 29.2 Weeks STANDARD_DEVIATION 2.5 | 34.5 Weeks STANDARD_DEVIATION 1.75 | 39.8 Weeks STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 46 Participants | 16 Participants |
| Sex: Female, Male Female | 23 Participants | 33 Participants | 10 Participants |
| Sex: Female, Male Male | 9 Participants | 17 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 18 |
| other Total, other adverse events | 0 / 32 | 0 / 18 |
| serious Total, serious adverse events | 0 / 32 | 0 / 18 |
Outcome results
Primary
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)
Population: Data was not collected for 4 preterm participants due to following reasons:~* bigeminy precluding hypoxia exposure (N=1),~* claustrophobia from wearing the mask (N=1),~* having to abruptly stop the scan to use the restroom (N=2).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preterm | Cardiac Glucose Uptake During Normoxic Rest (µg/Min) | 0.689 µg/min | Standard Deviation 0.546 |
| Term - Healthy Controls | Cardiac Glucose Uptake During Normoxic Rest (µg/Min) | 0.540 µg/min | Standard Deviation 0.454 |
p-value: 0.38Wilcoxon Rank Sum test
Primary
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)
Population: 5 preterm and 1 term participants did nor receive the allocated intervention due to :~* bigeminy precluding hypoxia exposure (N=1 preterm),~* claustrophobia from wearing the mask (N=1 preterm),~* having to abruptly stop the scan to use the restroom (N=2 preterm).~* image acquisition/reconstruction failure (n = 2,1 preterm and 1 term)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preterm | Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min) | -0.264 µg/min | Standard Deviation 0.588 |
| Term - Healthy Controls | Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min) | -0.003 µg/min | Standard Deviation 0.39 |
p-value: 0.12Wilcoxon Rank Sum test