Nutritional Status Clinical Trial
Official title:
Comparison to World Health Organization (WHO) Gold Standard of Extrapolation and Estimation Methods to Assess Length/Height in Critically Ill Children
NCT number | NCT03572504 |
Other study ID # | 6910 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 26, 2018 |
Est. completion date | January 21, 2019 |
Verified date | April 2019 |
Source | University Hospital, Strasbourg, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | January 21, 2019 |
Est. primary completion date | January 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpitaux Universitaires de Starsbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | identify the most reliable method (s) of pediatric resuscitation. | 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 |
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