NCT03976596

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2019

Completed
Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

June 4, 2019

Last Update Submit

February 2, 2026

Conditions

Healthy Infants

Keywords

neonatesmitochondriaMRI

Outcome Measures

Primary Outcomes (1)

  • In vivo mitochondrial capacity (ATPmax)

    In vivo mitochondrial capacity as measured by phosphorus magnetic resonance spectroscopy

    1 day

Eligibility Criteria

Age14 Days - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Study Officials

  • Leanne M Redman, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 6, 2019

Study Start

May 21, 2019

Primary Completion

July 2, 2019

Study Completion

July 2, 2019

Last Updated

February 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)