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

Pediatric Intensive Care Unit Clinical Trial

— EvTaReaP  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913247
• Other study ID #: 69HCL19_0031
• Status: Completed
• Start date: November 29, 2019
• Est. completion date: December 26, 2022

Study information

• Verified date: August 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: December 26, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Intensive Care Unit

Intervention

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.

Locations

Country	Name	City	State
Belgium	Service de réanimation pédiatrique Hôpital Reine Fabiola Hôpital Publique	Brussels
France	Service de réanimation pédiatrique Centre hospitalier universitaire de Bordeaux	Bordeaux
France	Hôpital Femme Mère Enfant	Bron
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 CHU La Timone AP-HM	Marseille
France	Service de réanimation pédiatrique Centre hospitalier universitaire de Nantes	Nantes
France	Service de réanimation pédiatrique Rue Du Morvan (CHRU NANCY - HOPITAUX DE BRABOIS)	Vandœuvre-lès-Nancy
Lebanon	Service de réanimation pédiatrique Hôpital de l'hôtel dieu de France	Beirut
Switzerland	Haute école de santé - HES-SO Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Countries where clinical trial is conducted

Belgium,  France,  Lebanon,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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