Measurement of in Vivo Mitochondrial Capacity in Infants

March 11, 2024 updated by: Leanne Redman, Pennington Biomedical Research Center

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 4 weeks (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • healthy, full-term infant
  • aged 14-28 days at Visit 1
  • willingness of parents to be notified of incidental findings from study procedures

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In vivo mitochondrial capacity (ATPmax)
Time Frame: 1 day
In vivo mitochondrial capacity as measured by phosphorus magnetic resonance spectroscopy
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Leanne M Redman, PhD, Pennington Biomedical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2019

Primary Completion (Actual)

July 2, 2019

Study Completion (Actual)

July 2, 2019

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PBRC 2018-051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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