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Measurement of in Vivo Mitochondrial Capacity in Infants

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ClinicalTrials.gov Identifier: NCT03976596
Recruitment Status : Suspended (Study temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.)
First Posted : June 6, 2019
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center

Brief 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.

Condition or disease
Healthy Infants

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Study Type : Observational
Estimated Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Measurement of in Vivo Mitochondrial Capacity in Infants: a 31P-MRS Pilot Study
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020



Primary Outcome Measures :
  1. In vivo mitochondrial capacity (ATPmax) [ Time Frame: 1 day ]
    In vivo mitochondrial capacity as measured by phosphorus magnetic resonance spectroscopy



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976596


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Leanne M Redman, PhD Pennington Biomedical Research Center
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Responsible Party: Leanne Redman, Associate Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03976596    
Other Study ID Numbers: PBRC 2018-051
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leanne Redman, Pennington Biomedical Research Center:
neonates
mitochondria
MRI