HealthyNCT06188377
Application of Bioimpedance Vector Analysis in Neonates
An observational study of Healthy, run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- measured by a impedance analyzer
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Chinese healthy term newborns born within 24 hours.
Who may be able to join
- Healthy term neonates of both sexes within 24 hours.
- Neonates whose parents or guardians consent with the research.
Who cannot join
- Infants with some disease and conditions that could interfere in the body composition (such as heart failure, blue light irradiation, sepsis, kidney injury, hepatic failure, transfusion) and newborns with congenital anomalies and/or genetic problems.
- Neonates whose parents or guardians refuse to participate in the research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Tian Zhichen, master, +8613066385364, tianzhichen63@163.com
About this study
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).
Read the 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
- Being tested
- measured by a impedance analyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measured by a impedance analyzerDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
the distribution of bioimpedance vector of chinese neonates
collect resistance and reactance of the subjects
Measured: till 2023-11-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start6 Nov 2023
- Primary completion31 Dec 2023
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Bin, Doctor, Study director, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188377
- Sponsor's protocol ID
- 2023-KY-154
- Status last verified
- Nov 2023
- First submitted
- 18 Dec 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Piccoli A, Fanos V, Peruzzi L, Schena S, Pizzini C, Borgione S, Bertino E, Chiaffoni G, Coppo R, Tato L. Reference values of the bioelectrical impedance vector in neonates in the first week after birth. Nutrition. 2002 May;18(5):383-7. doi: 10.1016/s0899-9007(02)00795-5.
PubMed 11985941Savino F, Grasso G, Cresi F, Oggero R, Silvestro L. Bioelectrical impedance vector distribution in the first year of life. Nutrition. 2003 Jun;19(6):492-6. doi: 10.1016/s0899-9007(02)00947-4.
PubMed 12781847Toffano RBD, Hillesheim E, Margutti AVB, Camelo Junior JS, Ferraz IS, Del Ciampo LA, Monteiro JP. Bioelectrical Impedance Vector Analysis in Healthy Term Infants in the First Three Months of Life in Brazil. J Am Coll Nutr. 2018 Feb;37(2):93-98. doi: 10.1080/07315724.2017.1364678. Epub 2017 Nov 7.
PubMed 29111907Margutti AV, Monteiro JP, Camelo JS Jr. Reference distribution of the bioelectrical impedance vector in healthy term newborns. Br J Nutr. 2010 Nov;104(10):1508-13. doi: 10.1017/S000711451000245X. Epub 2010 Jul 2.
PubMed 20594393
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Bioimpedance Vector Analysis in Neonates
- ClinicalTrials.gov ID
- NCT06188377
- Acronym / sponsor ID
- 2023-KY-154
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Chinese healthy term newborns born within 24 hours.
Key inclusion criteria (2 listed)
- Healthy term neonates of both sexes within 24 hours.
- Neonates whose parents or guardians consent with the research.
Key exclusion criteria (2 listed)
- Infants with some disease and conditions that could interfere in the body composition (such as heart failure, blue light irradiation, sepsis, kidney injury, hepatic failure, transfusion) and newborns with congenital anomalies and/or genetic problems.
- Neonates whose parents or guardians refuse to participate in the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measured by a impedance analyzerthe 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. | Device | – |
Primary outcome
the distribution of bioimpedance vector of chinese neonates
Time frame: till 2023-11-30
collect resistance and reactance of the subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Results publication: PubMed 11985941Piccoli A, Fanos V, Peruzzi L, Schena S, Pizzini C, Borgione S, Bertino E, Chiaffoni G, Coppo R, Tato L. Reference values of the bioelectrical impedance vector in neonates in the first week after birth. Nutrition. 2002 May;18(5):383-7. doi: 10.1016/s0899-9007(02)00795-5.
- Results publication: PubMed 12781847Savino F, Grasso G, Cresi F, Oggero R, Silvestro L. Bioelectrical impedance vector distribution in the first year of life. Nutrition. 2003 Jun;19(6):492-6. doi: 10.1016/s0899-9007(02)00947-4.
- Results publication: PubMed 29111907Toffano RBD, Hillesheim E, Margutti AVB, Camelo Junior JS, Ferraz IS, Del Ciampo LA, Monteiro JP. Bioelectrical Impedance Vector Analysis in Healthy Term Infants in the First Three Months of Life in Brazil. J Am Coll Nutr. 2018 Feb;37(2):93-98. doi: 10.1080/07315724.2017.1364678. Epub 2017 Nov 7.
- Results publication: PubMed 20594393Margutti AV, Monteiro JP, Camelo JS Jr. Reference distribution of the bioelectrical impedance vector in healthy term newborns. Br J Nutr. 2010 Nov;104(10):1508-13. doi: 10.1017/S000711451000245X. Epub 2010 Jul 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Bin, Doctor study director
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tian Zhichen, master (+8613066385364, tianzhichen63@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the distribution of bioimpedance vector of chinese neonates (time frame: till 2023-11-30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188377, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.