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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:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00890344
First received: April 27, 2009
Last updated: September 29, 2011
Last verified: September 2011
History of Changes

April 27, 2009
September 29, 2011
February 2009
August 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00890344 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
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Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography and Multiple-frequency Bio-impedance Analysis
"Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography (PeaPod) and Multiple-frequency Bio-impedance Analysis (BIA)"

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.
Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample

Full-term infants 10th percentile for gestational age, according to the Audipog's growth chart
Neonates
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
up to 1 Day
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00890344
BRD08/7-P
No
Annes Omnes, University Hospital of Nantes
Nantes University Hospital
Not Provided
Principal Investigator: Anne CA FRONDAS-CHAUTY, Dr CHU Nantes
Nantes University Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP