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Height Measurement in Critically Ill Children

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ClinicalTrials.gov Identifier: NCT03572504
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Critically Ill Child Nutritional Status Height Length Other: critically ill children

Study Design
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Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison to World Health Organization (WHO) Gold Standard of Extrapolation and Estimation Methods to Assess Length/Height in Critically Ill Children
Actual Study Start Date : February 26, 2018
Actual Primary Completion Date : January 21, 2019
Actual Study Completion Date : January 21, 2019
Groups and Cohorts
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Intervention Details:
  • Other: critically ill children
    Compare a series of measurement or size estimation techniques to the WHO standard to identify the most reliable method (s) of pediatric resuscitation.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
One tertiary care university children hospital Pediatric intensive care unit
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572504


Locations
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France
Hôpitaux Universitaires de Starsbourg
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03572504    
Other Study ID Numbers: 6910
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes