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

September 29, 2011 updated by: Nantes University Hospital

"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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Full-term infants 10th percentile for gestational age, according to the Audipog's growth chart

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
August 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
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
August 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Anne CA FRONDAS-CHAUTY, Dr, Chu Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Estimate)

September 30, 2011

Last Update Submitted That Met QC Criteria

September 29, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BRD08/7-P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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