NCT03572504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2019

Completed
Last Updated

September 19, 2024

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

June 19, 2018

Last Update Submit

September 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Age28 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

One tertiary care university children hospital Pediatric intensive care unit

You may qualify if:

  • age from 28 days to 18 years
  • admitted in pediatric intensive care
  • WHO standard not applicable
  • parent consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Starsbourg

Strasbourg, 67098, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

June 28, 2018

Study Start

February 26, 2018

Primary Completion

January 21, 2019

Study Completion

January 21, 2019

Last Updated

September 19, 2024

Record last verified: 2019-04

Locations