Evaluation of Methods for Extrapolating or Estimating the Size of Children in Pediatric Intensive Care (EvTaReaP)

Evaluation of Methods for Extrapolating or Estimating the Size of Children in Pediatric Intensive Care Compared With the Reference Method of the World Health Organization (WHO)

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).

Study Overview

• Status: Completed
• Conditions: Pediatric Intensive Care Unit
• Intervention / Treatment: Other: Size Measurement using a measuring tape, a caliper and a metric

• Study Type: Observational
• Enrollment (Actual): 477

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Service de réanimation pédiatrique Hôpital Reine Fabiola Hôpital Publique
• France
  • Bordeaux, France, 33000
    • Service de réanimation pédiatrique Centre hospitalier universitaire de Bordeaux
  • Bron, France, 69677
    • Hopital Femme Mere Enfant
  • Bron, France, 69677
    • Service de réanimation pédiatrique Hôpital cardiologique Louis Pradel
  • Lille, France, 59000
    • Service de réanimation et de surveillance continue pédiatrique CHRU de Lille
  • Marseille, France, 13005
    • Service de réanimation pédiatrique CHU La Timone AP-HM
  • Nantes, France, 44093
    • Service de réanimation pédiatrique Centre hospitalier universitaire de Nantes
  • Vandœuvre-lès-Nancy, France, 54500
    • Service de réanimation pédiatrique Rue Du Morvan (CHRU NANCY - HOPITAUX DE BRABOIS)
• Lebanon
  • Beirut, Lebanon
    • Service de réanimation pédiatrique Hôpital de l'hôtel dieu de France
• Switzerland
  • Geneva, Switzerland
    • Haute école de santé - HES-SO Genève

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients in pediatric intensive care unit

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Carole Ford-Chessel, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2019
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 26, 2022

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: 69HCL19_0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No