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

Completed

• Conditions: Pediatric Intensive Care Unit
• Interventions: Other: Size Measurement using a measuring tape, a caliper and a metric

• Registration Number: NCT03913247
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-12
• Study Start: 2019-11-29
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group with different size measures	Size Measurement using a measuring tape, a caliper and a metric	Each patient included in the study will have different measure of size.

Primary Outcome Measures

Name	Time	Method
reliability of a series of extrapolation measurement techniques or size estimation in pediatric intensive care units.	150 days	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%

Trial Locations

Locations (10)

Service de réanimation pédiatrique Hôpital Reine Fabiola Hôpital Publique; 🇧🇪 Brussels, Belgium

Service de réanimation pédiatrique Centre hospitalier universitaire de Nantes; 🇫🇷 Nantes, France

Service de réanimation pédiatrique CHU La Timone AP-HM; 🇫🇷 Marseille, France

Service de réanimation pédiatrique Hôpital cardiologique Louis Pradel; 🇫🇷 Bron, France

Service de réanimation et de surveillance continue pédiatrique CHRU de Lille; 🇫🇷 Lille, France

Service de réanimation pédiatrique Rue Du Morvan (CHRU NANCY - HOPITAUX DE BRABOIS); 🇫🇷 Vandœuvre-lès-Nancy, France

Haute école de santé - HES-SO Genève; 🇨🇭 Geneva, Switzerland

Service de réanimation pédiatrique Centre hospitalier universitaire de Bordeaux; 🇫🇷 Bordeaux, France

Service de réanimation pédiatrique Hôpital de l'hôtel dieu de France; 🇱🇧 Beirut, Lebanon

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France