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

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ClinicalTrials.gov Identifier: NCT03913247
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment
Pediatric Intensive Care Unit Other: Size Measurement using a measuring tape, a caliper and a metric

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Study Type : Observational
Estimated Enrollment : 462 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. reliability of a series of extrapolation measurement techniques or size estimation in pediatric intensive care units. [ Time Frame: 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%



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients in pediatric intensive care unit
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913247


Contacts
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Contact: Carole Ford-Chessel 4 27 85 59 55 ext +33 carole.ford-chessel@chu-lyon.fr
Contact: Julien Berthiller 4 27 85 63 01 ext +33 julien.berthiller@chu-lyon.fr

Locations
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France
Hôpital Femme Mère Enfant Not yet recruiting
Bron, France
Contact: Carole Ford-Chessel    4 27 85 59 55 ext +33    carole.ford-chessel@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Carole Ford-Chessel Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03913247     History of Changes
Other Study ID Numbers: 69HCL19_0031
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents