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

Neonates Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890344
• Other study ID #: BRD08/7-P
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: September 29, 2011
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2011
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Neonates

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No