- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03572504
Height Measurement in Critically Ill Children (EvTaRéaP)
Comparison to World Health Organization (WHO) Gold Standard of Extrapolation and Estimation Methods to Assess Length/Height in Critically Ill Children
Height/length has to be assessed accurately in critically ill children, as its value is required to assess nutritional status, to calculate nutritional requirements, to calculate body surface area (involved in drug prescriptions), and to assess pulmonary function.
The WHO has standardized practices to perform height/length measurements, but this gold standard is not applicable in critically ill children (who cannot stand and are equipped with catheters, tubes and various devices). It is not accurate to rely on previous measurements as children are continuously growing. No height/length measurement tool or method has been validated so far in this population, neither any estimation nor extrapolation methods.
The investigators aim to compare the WHO gold standard for height/length measurement to a list of other methods, validated in other children populations and currently used in the pediatric setting. We intend to compare each of them to the gold standard. The secondary objectives are to describe each height/length extrapolation or estimation method and to estimate the practical use of each method for critically ill children.
A prospective observational study is planned. 140 critically ill children admitted to pediatric intensive care unit (PICU) will be recruited.
Body segments (ulna, tibia, knee-heel, arm span) will be measured and length/height extrapolated from formulas used in different populations. Previous length/height measurements will be collected to draw growth curves and extrapolate actual length/height. Parents will be asked how tall their child is.
After PICU discharge, while the child meets WHO measurement standards, accurate length/height will be measured and compared to the results of the above mentioned techniques.
Comparison will be made in-between these results.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Strasbourg, France, 67098
- Hôpitaux Universitaires de Starsbourg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age from 28 days to 18 years
- admitted in pediatric intensive care
- WHO standard not applicable
- parent consent
Exclusion criteria:
- expected death before discharge
- expected that the child will not meet in the near future WHO standard criteria to measure height/length
- growth > 5% height before meeting the WHO criteria
- limb abnormalities, scoliosis, retractions.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
identify the most reliable method (s) of pediatric resuscitation.
Time Frame: 110 days
|
Compare a series of measurement or size estimation techniques to the WHO standard to identify the most reliable method (s) of pediatric resuscitation.
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110 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6910 (CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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