NCT02683473

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
14mo left

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress90%
Mar 2016Jun 2027

First Submitted

Initial submission to the registry

January 14, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

March 16, 2016

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

11.3 years

First QC Date

January 14, 2016

Last Update Submit

March 16, 2026

Conditions

Infant DevelopmentInfant Overnutrition

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Percent body fat

    Approximately 1 week

  • Physical activity counts

    Approximately 1 week

Study Arms (1)

Infants

Infants aged 1-3 months

Eligibility Criteria

Age1 Month - 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Leanne M Redman, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abby Altazan, M.S.

CONTACT

(225) 763-2801abby.altazan@pbrc.edu

Study Design

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

Study Record Dates

First Submitted

January 14, 2016

First Posted

February 17, 2016

Study Start

March 16, 2016

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)