Measurement of in Vivo Mitochondrial Capacity in Infants | NCT03976596

Studies
Measurement of in Vivo Mitochondrial Capacity in Infants

NCT03976596

Sponsor

Pennington Biomedical Research Center

Status

Terminated

Last Update Posted

Feb 3, 2026Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Healthy Infants

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decoupler equipment used for 31P magnetic resonance is being serviced

Expanded Access Info

Start Date

May 21, 2019Actual

Primary Completion Date

Jul 2, 2019Actual

Completion Date

Jul 2, 2019Actual

First Submitted Date

Jun 4, 2019

First Submission Date that Met QC Criteria

Jun 4, 2019

First Posted Date

Jun 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 3, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leanne Redman, Associate Professor, Pennington Biomedical Research CenterPrincipal Investigator

Lead Sponsor

Pennington Biomedical Research CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In vivo mitochondrial capacity (ATPmax)	In vivo mitochondrial capacity as measured by phosphorus magnetic resonance spectroscopy	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Days

Maximum Age

28 Days

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leanne M Redman, PhD	Pennington Biomedical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pennington Biomedical Research Center		Baton Rouge	Louisiana	70808	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided