NCT03913247

Brief Summary

Size is a key data used daily by dietary teams; the paramedical team, nurse and diet are in charge of its measures. In pediatric intensive care unit, a reliable size of the child must be obtained. It allows to realize:

  • a nutritional assessment based on the World Health Organization (WHO) nutritional indices such as the Body Mass Index (BMI), growth chart monitoring and other nutritional indices. Nutritional status should be assessed and followed in pediatric intensive care as it is correlated with the prognosis of children.
  • an estimate of the energy needs by calculation of the rest energy expenditure.
  • a calculation of the body surface, useful for drug prescription, evaluation of burn scores, calculation of water and energy requirements and indexing of hemodynamic and ventilatory data. An error in size measurement results in an error in BMI, calculation of energy requirements, and body surface area. The WHO has defined "gold standard" criteria for measuring height in children, distinguishing the less than two years in whom the size is measured strictly lengthened, using a metric, and the more than two years in which height is measured standing with a stadiometer. In the context of pediatric resuscitation, the criteria for WHO size measurement are difficult to meet (coma, sedation, respiratory assistance, catheter, monitoring, proclive position, etc.) compromising standing or rectitude required for measurements. The child is a growing organism. Health book sizes and declarative sizes are not always up-to-date. It is therefore important to overcome these difficulties by using estimating or extrapolation methods that are applicable and safe in pediatric intensive care unit. Currently, in pediatric intensive care units, the size evaluation, by direct measurement, estimation or extrapolation of segmental measurement, is not systematic because of the complexity of the measurement; To date, no method is used as a reference method in pediatric intensive care. Among Children in pediatric intensive care unit (which does not usually meet the criteria of the WHO Gold Standard for Measurement of Height), to determine the optimal method for size measurement, by comparing different methods of estimating / extrapolating the size, gold standard WHO (achievable after the stay in intensive care).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
477

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
4 countries

10 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

November 29, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2022

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

3.1 years

First QC Date

April 10, 2019

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • reliability of a series of extrapolation measurement techniques or size estimation in pediatric intensive care units.

    The reliability of the estimation / size extrapolation methods will be defined by the average relative error relative to the WHO gold standard. A method will be considered reliable and without clinical impact if the absolute value of the average relative error is less than 3.5%

    150 days

Study Arms (1)

Group with different size measures

Each patient included in the study will have different measure of size.

Other: Size Measurement using a measuring tape, a caliper and a metric

Interventions

Each patient will have the following measure: measure of the span, the tibia, the ulna, the distance between the hill and the knee, the head, the trunk and the leg. The different measures will be done using a measuring tape and with a caliper. Before leaving the intensive care unit, each patients will be measured according to the WHO standard, that is to say strictly lengthened, using a metric for patient younger than 2 and stand up using a stadiometer for patient older than 2.

Group with different size measures

Eligibility Criteria

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

patients in pediatric intensive care unit

You may qualify if:

  • Children aged from 28 days to 18 years old.
  • Admitted in pediatric intensive care unit with a resuscitation situation (at least one system failure including respiratory and/or hemodynamic and/or neurological).
  • Children whose size was not measurable, at the time of the admission in pediatric intensive care unit according to WHO standards.
  • Patient affiliated to a social security system

You may not qualify if:

  • No expected evolution to a clinical state allowing the size measure according to the WHO standards according to age.
  • Stature growth greater (defined by WHO growth velocity scale according to age and sex) than 5% before the expected delay allowing the size measure using the WHO standards according to age
  • Children with skeleton malformation, dwarfism, abnormal limb.
  • Expected death before the end of the stay in pediatric intensive care unit
  • Parents or patients able to answer, refusing to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Service de réanimation pédiatrique Hôpital Reine Fabiola Hôpital Publique

Brussels, 1020, Belgium

Location

Service de réanimation pédiatrique Centre hospitalier universitaire de Bordeaux

Bordeaux, 33000, France

Location

Hôpital Femme Mère Enfant

Bron, 69677, France

Location

Service de réanimation pédiatrique Hôpital cardiologique Louis Pradel

Bron, 69677, France

Location

Service de réanimation et de surveillance continue pédiatrique CHRU de Lille

Lille, 59000, France

Location

Service de réanimation pédiatrique CHU La Timone AP-HM

Marseille, 13005, France

Location

Service de réanimation pédiatrique Centre hospitalier universitaire de Nantes

Nantes, 44093, France

Location

Service de réanimation pédiatrique Rue Du Morvan (CHRU NANCY - HOPITAUX DE BRABOIS)

Vandœuvre-lès-Nancy, 54500, France

Location

Service de réanimation pédiatrique Hôpital de l'hôtel dieu de France

Beirut, Lebanon

Location

Haute école de santé - HES-SO Genève

Geneva, Switzerland

Location

Related Publications (1)

  • Ford Chessel C, Berthiller J, Haran I, Tume LN, Bourgeaud C, Tsapis M, Gaillard-Le Roux B, Gauvard E, Loire C, Guillot C, Mouneydier K, Nolent P, Blache T, Cour Andlauer F, Rooze S, Jotterand Chaparro C, Morice C, Subtil F, Huot M, Valla FV. Accurate height and length estimation in hospitalized children not fulfilling WHO criteria for standard measurement: a multicenter prospective study. Eur J Pediatr. 2024 Oct;183(10):4275-4286. doi: 10.1007/s00431-024-05692-3. Epub 2024 Jul 25.

Study Officials

  • Carole Ford-Chessel

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 12, 2019

Study Start

November 29, 2019

Primary Completion

December 22, 2022

Study Completion

December 26, 2022

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations