NCT06188377

Application of Bioimpedance Vector Analysis in Neonates

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to learn about the distribution of bioimpedance vector of healthy neonates in China in health conditions. The main question it aims to answer are:whether the distribution of bioimpedance vector of healthy neonates in China is correspond to that in other countries.Participants will be measures by NUTRILAB impedance analyzer (Akern, Florence, Italy).

Detailed description

Data such as demographic data, maternal background, gestational age at birth, gestational history, weight and height, will be collected from medical records.Each day we will measure 3 newborns chosen by simple random sampling, for which we will use Excel function.Bioimpedance analysis will be performed according to the manufacturer's instructions within the first 24 hours of life, using a tetrapolar configuration of electrodes (at 400 μA and 50 kHz) with a NUTRILAB impedance analyzer (Akern, Florence, Italy). BIA data will be acquired when they are still, preferably in quiet sleep, avoiding contact between the upper limbs and trunk, and between the legs. Two outer distal adhesive electrodes will be placed on the dorsal surface of the right hand and foot, proximal to the metacarpal-phalangeal and metatarsal-phalangeal joints, and 2 inner electrodes will be placed proximally on the right fore-arm and pretibial region, leaving 5.5cm of free skin around the outer electrodes. The surface should have no skin lesions and will be cleaned with chlorhexidine solution. R and Xc values will be measured in triplicate in each infant, and the arithmetic mean will be used. The device will be calibrated every 20 evaluations(approximately once a week) using a resistor provided by the manufacturer. All the measurements will be performed at the nursery by the same investigator.We will use BIVA to analyse the result: the components of the impedance vector (R and Xc) will be normalized by the height (R/H \[ohm/m\] and Xc/H \[ohm/m\], respectively). PA is obtained from the arc-tangent ratio Xc:R. To transform it from radians to degrees, the result is multiplied by 180°/π。Using the RXc graph method the bivariate 95% confidence intervals (ellipses) of the mean vectors of the newborns will be established. From the bivariate normal distribution of R/H and Xc/H, the bivariate 95%, 75%, and 50% tolerance intervals will be drawn. We will use the Hotelling T2 test and univariate analysis (F test) by the BIVA software 2002 for the analysis of the CI for the comparison of the subject groups and for the analysis of tolerance intervals. The significance level is set at 0.05 in all tests.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	measured by a impedance analyzer	the healthy chinese neonates will be measured by a impedance analyzer, and will be compared with that of other ethnicity whose data have been reported by literatures.

Timeline

• Start date: 2023-11-06
• Primary completion: 2023-12-31
• Completion: 2024-07-31
• First posted: 2024-01-03
• Last updated: 2024-07-25

Locations

1 site across 1 country: China