Infant DevelopmentBabyEE PilotNCT02683473
Measurement of Energy Metabolism in Infants
An observational study of Infant Development and Infant Overnutrition, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to measure energy expenditure during the first 3 months of life in infants. Read more about this study
- Who is it for?
- Ages 1 month to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Infant Overnutrition
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2016to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Full-term infants aged 1 to 3 months who are exclusively fed breast milk and/or infant formula will be recruited
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Abby Altazan, M.S., (225) 763-2801, abby.altazan@pbrc.edu
Leanne M Redman, Ph.D.
About this study
Official title: Measurement of Energy Metabolism in Infants: BabyEE Pilot
The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.
Read the 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?
- Conditions
- Infant Development, Infant Overnutrition
- Medical subject headings
- Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants | Infants aged 1-3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Approximately 1 week
Secondary outcomes (2)
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.
Measured: Approximately 1 week
Physical activity counts
Physical activity counts by Actigraph accelerometer measured over approximately 7 days in infants aged 1-3 months.
Measured: Approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start16 Mar 2016
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne M Redman, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683473
- Sponsor's protocol ID
- PBRC 2015-061
- Other IDs
- P30DK072476-10
- Acronym
- BabyEE Pilot
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2016
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Energy Metabolism in Infants: BabyEE Pilot
- ClinicalTrials.gov ID
- NCT02683473
- Acronym / sponsor ID
- BabyEE Pilot / PBRC 2015-061
- Conditions
- Infant Development, Infant Overnutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants | – | –Infants aged 1-3 months |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Full-term infants aged 1 to 3 months who are exclusively fed breast milk and/or infant formula will be recruited
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Energy Expenditure by infant metabolic chamber
Time frame: Approximately 1 week
Energy expenditure by infant metabolic chamber measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.
Energy expenditure by doubly labeled water
Time frame: Approximately 1 week
Energy expenditure by doubly labeled water measured over approximately 7 days in infants aged 1-3 months
2 secondary outcomes
Percent body fat
Time frame: Approximately 1 week
Physical activity counts
Time frame: Approximately 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leanne M Redman, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development and Infant Overnutrition, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abby Altazan, M.S. ((225) 763-2801, abby.altazan@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Expenditure by infant metabolic chamber (time frame: Approximately 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.