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Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography and Multiple-frequency Bio-impedance Analysis

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00890344
Collaborator
(none)
40
Enrollment
1
Location
5.9
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Low birth weight and prematurity are associated with adverse metabolic outcome in adult life. Yet it remains to be determined whether this outcome is the consequence of the low birth weight per se, or of the catch up growth achieved in Neonatology units using an early, 'aggressive' nutritional management. As a matter of fact, 'aggressive' nutrition may promote fat mass, rather than lean body mass accretion. Assessment of body composition therefore is key to evaluate the efficacy of the nutritional management of these infants. Scarce data is, however, available in the literature about the body composition of healthy full-term neonates in the first few days of life.

The aim of this study is to:

  1. Evaluate the feasibility and reproducibility of a safe and non invasive method of measurement of infant body composition by Air Displacement Plethysmography (PeaPod). Anthropometry and BIA will be used as the reference techniques to assess the accuracy of the PeaPod

  2. Describe the body composition (fat mass, fat free mass) of healthy full-term neonates in the first few weeks of life

  3. Obtain data on the total body water content of healthy full term infants from BIA.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Time Perspective:
    Prospective
    Official Title:
    "Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography (PeaPod) and Multiple-frequency Bio-impedance Analysis (BIA)"
    Study Start Date :
    Feb 1, 2009
    Actual Primary Completion Date :
    Aug 1, 2009
    Actual Study Completion Date :
    Aug 1, 2009

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy and reproducibility of the PeaPod compared with Anthropometry and BIA. We defined that assessments are convergent if the difference between methods is less than 10 percent. [August 2009]

    Secondary Outcome Measures

    1. Describe the body composition (fat mass, fat free mass) of healthy full-term neonates To get data on the total body water that we can refer to from BIA. [August 2009]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 1 Day
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Full-term infants

    • 10th percentile for gestational age, according to the Audipog's growth chart

    Exclusion Criteria:

    • Congenital diseases

    • Chromosomal abnormalities

    • Any disease requiring intensive care

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Universitaire Nantes France 44093

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    • Principal Investigator: Anne CA FRONDAS-CHAUTY, Dr, CHU Nantes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00890344
    Other Study ID Numbers:
    • BRD08/7-P
    First Posted:
    Apr 29, 2009
    Last Update Posted:
    Sep 30, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by , ,
    PeaPod
    BIA
    Anthropometry
    Body Composition
    Fat Mass
    Total Body Water
    Neonatology

    Study Results

    No Results Posted as of Sep 30, 2011