NCT01905085

Brief Summary

Indirect calorimetry is valuable in determining resting energy expenditure in infants, children and adults. This measure will estimate the number of calories needed per day under resting conditions. Adding physical activity measures will help estimate total energy requirements in individuals. With the rise in obesity, numerous programs of prevention are being developed. Being able to characterize carefully energy intake and energy expenditure is one of the challenges of most of these initiatives.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

2.8 years

First QC Date

July 9, 2013

Last Update Submit

September 8, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measure Resting energy expenditure in infants

    We will measure resting energy expenditure in infants and then they will come back for a second visit and get the same measurement to see if there is a significant difference between the two measures.

    2 days

Interventions

Eligibility Criteria

Age3 Months - 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy infants

You may qualify if:

  • months old +/- 2 weeks
  • Can fall asleep easily
  • Usually sleeps more than 30 min
  • Accept formula as an alternative feeding

You may not qualify if:

  • Pulmonary or respiratory disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 23, 2013

Study Start

November 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 10, 2015

Record last verified: 2015-09