Healthy InfantsNCT03976596
Measurement of in Vivo Mitochondrial Capacity in Infants
An observational study of Healthy Infants, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The overarching aim of this project is to determine the test re-test reliability of 31P-magnetic resonance spectroscopy measurements in infants. Primary endpoints include two separate measures of in vivo mitochondrial capacity (ATPmax) over a 1-10 day period to assess feasibility and reliability. Read more about this study
- Who is it for?
- Ages 14 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2019to 2 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: This cross-sectional study will enroll up to 18 infants. Infants will complete 2 study visits over a 1-10 day period for outcome measures.
Who may be able to join
- healthy, full-term infant
- aged 14-28 days at Visit 1
- willingness of parents to be notified of incidental findings from study procedures
Who cannot join
- born preterm
- implanted metal or electronic objects that render MRI unsafe
- unable to complete 2 clinic visits 1-10 days apart at Pennington Biomedical Research Center
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Measurement of in Vivo Mitochondrial Capacity in Infants: a 31P-MRS Pilot Study
The overarching aim of this project is to determine the test re-test reliability of 31P-magnetic resonance spectroscopy measurements in infants. Primary endpoints include two separate measures of in vivo mitochondrial capacity (ATPmax) over a 1-10 day period to assess feasibility and reliability.
- Conditions
- Healthy Infants
- Keywords
- neonates, mitochondria, MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
In vivo mitochondrial capacity (ATPmax)
In vivo mitochondrial capacity as measured by phosphorus magnetic resonance spectroscopy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start21 May 2019
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
Why it stopped: Decoupler equipment used for 31P magnetic resonance is being serviced
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne M Redman, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976596
- Sponsor's protocol ID
- PBRC 2018-051
- Status last verified
- Feb 2026
- First submitted
- 4 Jun 2019
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of in Vivo Mitochondrial Capacity in Infants: a 31P-MRS Pilot Study
- ClinicalTrials.gov ID
- NCT03976596
- Acronym / sponsor ID
- PBRC 2018-051
- Conditions
- Healthy Infants
- Keywords
- neonates, mitochondria, MRI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decoupler equipment used for 31P magnetic resonance is being serviced
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching aim of this project is to determine the test re-test reliability of 31P-magnetic resonance spectroscopy measurements in infants. Primary endpoints include two separate measures of in vivo mitochondrial capacity (ATPmax) over a 1-10 day period to assess feasibility and reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This cross-sectional study will enroll up to 18 infants. Infants will complete 2 study visits over a 1-10 day period for outcome measures.
Key inclusion criteria (3 listed)
- healthy, full-term infant
- aged 14-28 days at Visit 1
- willingness of parents to be notified of incidental findings from study procedures
Key exclusion criteria (3 listed)
- born preterm
- implanted metal or electronic objects that render MRI unsafe
- unable to complete 2 clinic visits 1-10 days apart at Pennington Biomedical Research Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In vivo mitochondrial capacity (ATPmax)
Time frame: 1 day
In vivo mitochondrial capacity as measured by phosphorus magnetic resonance spectroscopy
Results and safety
The study was stopped early (reason given: Decoupler equipment used for 31P magnetic resonance is being serviced). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Leanne M Redman, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Infants, run by Pennington Biomedical Research Center 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 3 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: stopped early, as of the sponsor's last update on 3 Feb 2026. 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. 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?
The study was stopped early (reason given: Decoupler equipment used for 31P magnetic resonance is being serviced). Results are not available in the source record.
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?
In vivo mitochondrial capacity (ATPmax) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.