Measurement of in Vivo Mitochondrial Capacity in Infants

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: Healthy Infants

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes

• 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

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)	In vivo mitochondrial capacity as measured by phosphorus magnetic resonance spectroscopy	1 day

Collaborators and Investigators

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

Study record dates

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): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: MRI; mitochondria; neonates
• 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
• product manufactured in and exported from the U.S.: No