Clinical trial NCT03913247: Evaluation of Methods for Extrapolating or Estimating the Size of Children in Pediatric Intensive Care
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Intensive Care Unit
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 477
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in pediatric intensive care unit

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).


Eligibility criteria: 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

Primary outcomes:
measure: reliability of a series of extrapolation measurement techniques or size estimation in pediatric intensive care units.
timeFrame: 150 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Service de réanimation pédiatrique Hôpital Reine Fabiola Hôpital Publique
city: Bordeaux
country: France
facility: Service de réanimation pédiatrique Centre hospitalier universitaire de Bordeaux
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Bron
country: France
facility: Service de réanimation pédiatrique Hôpital cardiologique Louis Pradel
city: Lille
country: France
facility: Service de réanimation et de surveillance continue pédiatrique CHRU de Lille
city: Marseille
country: France
facility: Service de réanimation pédiatrique CHU La Timone AP-HM
city: Nantes
country: France
facility: Service de réanimation pédiatrique Centre hospitalier universitaire de Nantes
city: Vandœuvre-lès-Nancy
country: France
facility: Service de réanimation pédiatrique Rue Du Morvan (CHRU NANCY - HOPITAUX DE BRABOIS)
city: Beirut
country: Lebanon
facility: Service de réanimation pédiatrique Hôpital de l'hôtel dieu de France
city: Geneva
country: Switzerland
facility: Haute école de santé - HES-SO Genève
Study officials:
affiliation: Hospices Civils de Lyon
name: Carole Ford-Chessel
role: PRINCIPAL_INVESTIGATOR
References: