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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00890344
First Posted: April 29, 2009
Last Update Posted: September 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nantes University Hospital
  Purpose

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
Neonates

Study Type: Observational
Study Design: 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)"

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: August 2009 ]

Secondary Outcome Measures:
  • 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. [ Time Frame: August 2009 ]

Estimated Enrollment: 40
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Full-term infants 10th percentile for gestational age, according to the Audipog's growth chart
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890344


Locations
France
Centre Hospitalier Universitaire
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Anne CA FRONDAS-CHAUTY, Dr CHU Nantes
  More Information

Responsible Party: Annes Omnes, University Hospital of Nantes
ClinicalTrials.gov Identifier: NCT00890344     History of Changes
Other Study ID Numbers: BRD08/7-P
First Submitted: April 27, 2009
First Posted: April 29, 2009
Last Update Posted: September 30, 2011
Last Verified: September 2011

Keywords provided by Nantes University Hospital:
PeaPod
BIA
Anthropometry
Body Composition
Fat Mass
Total Body Water
Neonatology