Measurement of Energy Metabolism in Infants | NCT02683473

Studies
Measurement of Energy Metabolism in Infants

NCT02683473

Sponsor

Pennington Biomedical Research Center

Status

Recruiting

Last Update Posted

Mar 18, 2026Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Infant Development
Infant Overnutrition

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

ID	Type	Description	Link
P30DK072476-10	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 16, 2016Actual

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Jan 14, 2016

First Submission Date that Met QC Criteria

Feb 10, 2016

First Posted Date

Feb 17, 2016Estimated

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

Mar 16, 2026

Last Update Posted Date

Mar 18, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leanne Redman, Principal Investigator, Pennington Biomedical Research CenterPrincipal Investigator

Lead Sponsor

Pennington Biomedical Research CenterOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purpose of this study is to measure energy expenditure during the first 3 months of life in infants.

Detailed Description

This study intends to establish the feasibility of undertaking comprehensive metabolic phenotyping in infants. The overarching aim is to complete a prospective assessment of energy expenditure in the new infant metabolic chamber approximately one week apart to determine the accuracy and precision of infant protocols related to energy metabolism (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) and physical activity. This cross-sectional study will answer the following questions:

What is the test re-test reliability of measuring energy expenditure (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) in an infant under the same conditions, 5-7 days apart?
What is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study?
How do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?

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

70Estimated

Label	Type	Description	Intervention Names
Infants		Infants aged 1-3 months

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Energy Expenditure by infant metabolic chamber	Energy expenditure by infant metabolic chamber measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.	Approximately 1 week
Energy expenditure by doubly labeled water	Energy expenditure by doubly labeled water measured over approximately 7 days in infants aged 1-3 months	Approximately 1 week

Secondary Outcomes

Measure	Description	Time Frame
Percent body fat	Percent body fat by PEA POD measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.	Approximately 1 week
Physical activity counts	Physical activity counts by Actigraph accelerometer measured over approximately 7 days in infants aged 1-3 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, full-term infant
Aged 1 month (28 days) to 3 months (12 weeks, 6 days) at the first visit
Exclusively fed breast milk and/or infant formula
Willing to accept doubly-labeled water

Exclusion Criteria:

Unable to complete 3 clinic visits within about 14 days at Pennington Biomedical Research Center
Born preterm (< 37 weeks gestation)
Congenital abnormality or disability
Gastric reflux
Acute illness within 7 days of the study (fever, diarrhea)
Use of medications to treat a chronic condition (does not include use of vitamin supplements or PRN medication for flatulence or reflux such as Pepcid)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

3 Months

Standard Ages

Child

Study Population

Full-term infants aged 1 to 3 months who are exclusively fed breast milk and/or infant formula will be recruited

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abby Altazan, M.S.	Contact	(225) 763-2801		abby.altazan@pbrc.edu

Overall Officials

Name	Affiliation	Role
Leanne M Redman, Ph.D.	Pennington Biomedical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pennington Biomedical Research Center	Recruiting	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

Condition Browse Module

MeSH Terms

ID	Term
D007228	Infant Nutrition Disorders

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

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Browse Branches

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