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NCT03976596 Clinical Trial

Measurement of in Vivo Mitochondrial Capacity in Infants

Healthy Infants Clinical Trial

Official title:
Measurement of in Vivo Mitochondrial Capacity in Infants: a 31P-MRS Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03976596
Other study ID # PBRC 2018-051
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 21, 2019
Est. completion date July 2, 2019

Study information
Verified date March 2024
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date July 2, 2019
Est. primary completion date July 2, 2019
Accepts healthy volunteers
Gender All
Age group 14 Days to 28 Days
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary In vivo mitochondrial capacity (ATPmax) In vivo mitochondrial capacity as measured by phosphorus magnetic resonance spectroscopy 1 day
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