Infant,PrematurePET-MRINCT03245723

Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI)

A study testing Pulmonary Function Testing, Electrocardiogram and Positron Emission Tomography in people with Infant,Premature, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this research is to determine the effect of premature birth on later heart function and metabolism. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Infant,Premature
What is being tested?: Pulmonary Function Testing, Electrocardiogram and Positron Emission Tomography
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 20 Sep 2017to 26 Feb 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UW Madison
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Cardiac Function and Metabolism in Young Adults Born Premature

The purpose of this research is to determine the effect of premature birth on later heart function and metabolism.

Read the 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.

Conditions: Infant,Premature
Being tested: Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, Magnetic Resonance Imaging
Keywords: premature adults, premature, premature lung function, premature cardiac function, MRI, PET
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulmonary Function TestingProcedure or surgery
Subjects will undergo Spirometry and Plethysmography
ElectrocardiogramProcedure or surgery
Subjects will undergo an electrocardiogram to ensure sinus rhythm
Positron Emission TomographyProcedure or surgery
Subjects will undergo positron emission tomography to detect images of the heart
Magnetic Resonance ImagingProcedure or surgery
Subjects will undergo positron magnetic resonance imaging to detect images of the heart

Study groups in NCT03245723
Study group	Role	What they receive
Preterm	Active comparator	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. Receives: Procedure: Pulmonary Function Testing; Procedure: Electrocardiogram; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging
Term - Healthy Controls	Placebo comparator	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. Receives: Procedure: Pulmonary Function Testing; Procedure: Electrocardiogram; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiac Glucose Uptake During Normoxic Rest (µg/Min)
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
Measured: 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.
Measured: Visit 1 (1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 201726 Feb 2020

First posted10 Aug 2017
Study start20 Sep 2017
Primary completion26 Feb 2020
Study completion26 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Infant,PrematureStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03245723
Sponsor's protocol ID: 2017-0238
Other IDs: UL1TR000427, A534285, SMPH/MEDICINE/MEDICINE*P, Protocol Version 4/23/2019
Acronym: PET-MRI
Status last verified: Jan 2021
First submitted: 8 Aug 2017
Last updated: 4 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant

All Infant,Premature trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardiac Function and Metabolism in Young Adults Born Premature
ClinicalTrials.gov ID: NCT03245723
Acronym / sponsor ID: PET-MRI / 2017-0238
Conditions: Infant,Premature
Keywords: premature adults, premature, premature lung function, premature cardiac function, MRI, PET
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), American Heart Association
Study start: 20 Sep 2017 (actual)
Primary completion: 26 Feb 2020 (actual)
Study completion: 26 Feb 2020 (actual)
First posted: 10 Aug 2017 (actual)
Results: Posted 4 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this research is to determine the effect of premature birth on later heart function and metabolism.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Preterm	Active comparator	Procedure: Pulmonary Function Testing, Procedure: Electrocardiogram, Procedure: Positron Emission Tomography, Procedure: Magnetic Resonance ImagingParticipants 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.
Term - Healthy Controls	Placebo comparator	Procedure: Pulmonary Function Testing, Procedure: Electrocardiogram, Procedure: Positron Emission Tomography, Procedure: Magnetic Resonance ImagingHealthy 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.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pulmonary Function TestingSubjects will undergo Spirometry and Plethysmography	Procedure or surgery	Preterm, Term - Healthy Controls
ElectrocardiogramSubjects will undergo an electrocardiogram to ensure sinus rhythm	Procedure or surgery	Preterm, Term - Healthy Controls
Positron Emission TomographySubjects will undergo positron emission tomography to detect images of the heart	Procedure or surgery	Preterm, Term - Healthy Controls
Magnetic Resonance ImagingSubjects will undergo positron magnetic resonance imaging to detect images of the heart	Procedure or surgery	Preterm, Term - Healthy Controls

Primary outcome

Cardiac Glucose Uptake During Normoxic Rest (µg/Min)
Time frame: 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)
Time frame: Visit 1 (1 day)
Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.

Results and safety

Results posted to the registry on 4 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Preterm	32	27
Term - Healthy Controls	18	17

Primary outcome: Cardiac Glucose Uptake During Normoxic Rest (µg/Min)

Time frame: Visit 1 (1 day). Mean (Standard Deviation). Unit: µg/min

Measure	Preterm n = 28	Term - Healthy Controls n = 18
Value	0.689 (0.546)	0.540 (0.454)

Preterm vs Term - Healthy Controls: p = 0.38, Wilcoxon Rank Sum test

Population analysed: 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).

Primary outcome: Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min)

Time frame: Visit 1 (1 day). Mean (Standard Deviation). Unit: µg/min

Measure	Preterm n = 27	Term - Healthy Controls n = 17
Value	-0.264 (0.588)	-0.003 (0.390)

Preterm vs Term - Healthy Controls: p = 0.12, Wilcoxon Rank Sum test

Population analysed: 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)

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preterm	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Term - Healthy Controls	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Infant,Premature

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kara N Goss, MD principal investigator

The University of Wisconsin School of Medicine and Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary Function Testing, Electrocardiogram and Positron Emission Tomography in people with Infant,Premature, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac Glucose Uptake During Normoxic Rest (µg/Min) (time frame: Visit 1 (1 day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03245723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.