Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Infant 31p
Previous Study | Return to List | Next Study

Measurement of in Vivo Mitochondrial Capacity in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03976596
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : October 29, 2019
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

Layout table for study information
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 : March 15, 2020
Estimated Study Completion Date : March 15, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Abby D Altazan, MS 225-763-2801 abby.duhe@pbrc.edu

Locations
Layout table for location information
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Abby D Altazan, MS    225-763-2801    abby.duhe@pbrc.edu   
Sub-Investigator: Nicholas T Broskey, PhD         
Sub-Investigator: Daniel Hsia, MD         
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Layout table for investigator information
Principal Investigator: Leanne M Redman, PhD Pennington Biomedical Research Center

Layout table for additonal information
Responsible Party: Leanne Redman, Associate Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03976596     History of Changes
Other Study ID Numbers: PBRC 2018-051
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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