Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography and Multiple-frequency Bio-impedance Analysis
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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:
- 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
- Describe the body composition (fat mass, fat free mass) of healthy full-term neonates in the first few weeks of life
- 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)" |
- 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 ]
- 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 ]
| 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| Ages Eligible for Study: | up to 1 Day |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Full-term infants 10th percentile for gestational age, according to the Audipog's growth chart
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 More Information
No publications provided
| Responsible Party: | Annes Omnes, University Hospital of Nantes |
| ClinicalTrials.gov Identifier: | NCT00890344 History of Changes |
| Other Study ID Numbers: | BRD08/7-P |
| Study First Received: | April 27, 2009 |
| Last Updated: | September 29, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Nantes University Hospital:
|
PeaPod BIA Anthropometry Body Composition |
Fat Mass Total Body Water Neonatology |
ClinicalTrials.gov processed this record on June 17, 2013