Pediatric Intensive Care UnitEvTaReaPNCT03913247
Evaluation of Methods for Extrapolating or Estimating the Size of Children in Pediatric Intensive Care
An observational study of Pediatric Intensive Care Unit, run by Hospices Civils de Lyon at 10 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Pediatric Intensive Care Unit
- What is being tested?
- Size Measurement using a measuring tape, a caliper and a metric
- How many people
- 477 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 29 Nov 2019to 26 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients in pediatric intensive care unit
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
France7 sites
Service de réanimation pédiatrique Centre hospitalier universitaire de Bordeaux
Bordeaux, 33000
Hôpital Femme Mère Enfant
Bron, 69677
Service de réanimation pédiatrique Hôpital cardiologique Louis Pradel
Bron, 69677
Service de réanimation et de surveillance continue pédiatrique CHRU de Lille
Lille, 59000
Service de réanimation pédiatrique CHU La Timone AP-HM
Marseille, 13005
Service de réanimation pédiatrique Centre hospitalier universitaire de Nantes
Nantes, 44093
Service de réanimation pédiatrique Rue Du Morvan (CHRU NANCY - HOPITAUX DE BRABOIS)
Vandœuvre-lès-Nancy, 54500
Belgium1 site
Service de réanimation pédiatrique Hôpital Reine Fabiola Hôpital Publique
Brussels, 1020
Lebanon1 site
Service de réanimation pédiatrique Hôpital de l'hôtel dieu de France
Beirut
About this study
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)
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:
Read more
- 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).
- Conditions
- Pediatric Intensive Care Unit
- Being tested
- Size Measurement using a measuring tape, a caliper and a metric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Size Measurement using a measuring tape, a caliper and a metricOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group with different size measures | Each patient included in the study will have different measure of size. Receives: Other: Size Measurement using a measuring tape, a caliper and a metric |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start29 Nov 2019
- Primary completion22 Dec 2022
- Study completion26 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole Ford-Chessel, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913247
- Sponsor's protocol ID
- 69HCL19_0031
- Acronym
- EvTaReaP
- Status last verified
- Nov 2025
- First submitted
- 10 Apr 2019
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ford Chessel C, Berthiller J, Haran I, Tume LN, Bourgeaud C, Tsapis M, Gaillard-Le Roux B, Gauvard E, Loire C, Guillot C, Mouneydier K, Nolent P, Blache T, Cour Andlauer F, Rooze S, Jotterand Chaparro C, Morice C, Subtil F, Huot M, Valla FV. Accurate height and length estimation in hospitalized children not fulfilling WHO criteria for standard measurement: a multicenter prospective study. Eur J Pediatr. 2024 Oct;183(10):4275-4286. doi: 10.1007/s00431-024-05692-3. Epub 2024 Jul 25.
PubMed 39052138
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03913247
- Acronym / sponsor ID
- EvTaReaP / 69HCL19_0031
- Conditions
- Pediatric Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 26 Dec 2022 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group with different size measures | – | Other: Size Measurement using a measuring tape, a caliper and a metricEach patient included in the study will have different measure of size. |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients in pediatric intensive care unit
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Size Measurement using a measuring tape, a caliper and a metricEach 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. | Other | Group with different size measures |
Primary outcome
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 39052138Ford Chessel C, Berthiller J, Haran I, Tume LN, Bourgeaud C, Tsapis M, Gaillard-Le Roux B, Gauvard E, Loire C, Guillot C, Mouneydier K, Nolent P, Blache T, Cour Andlauer F, Rooze S, Jotterand Chaparro C, Morice C, Subtil F, Huot M, Valla FV. Accurate height and length estimation in hospitalized children not fulfilling WHO criteria for standard measurement: a multicenter prospective study. Eur J Pediatr. 2024 Oct;183(10):4275-4286. doi: 10.1007/s00431-024-05692-3. Epub 2024 Jul 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole Ford-Chessel principal investigator
Hospices Civils de Lyon
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Intensive Care Unit, run by Hospices Civils de Lyon at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Belgium, Lebanon, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reliability of a series of extrapolation measurement techniques or size estimation in pediatric intensive care units. (time frame: 150 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03913247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.