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Completed

NCT Number: NCT00890344

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

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.

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Key information

Conditions

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

    Time frame: August 2009

Secondary outcomes

  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.

    Time frame: August 2009

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 29, 2009
Registry last updated
Sep 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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