Height Measurement in Critically Ill Children (EvTaRéaP)

September 16, 2024 updated by: University Hospital, Strasbourg, France

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

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

140

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

      • Strasbourg, France, 67098
        • Hôpitaux Universitaires de Starsbourg

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

4 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

One tertiary care university children hospital Pediatric intensive care unit

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

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

  • 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.
110 days

Collaborators and Investigators

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

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 (Actual)

February 26, 2018

Primary Completion (Actual)

January 21, 2019

Study Completion (Actual)

January 21, 2019

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 6910 (CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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