DeliriumDeliRePNCT04954261
Delirium Detection in Pediatric Intensive Care Unit Through a French Translation of the CAPD : a French Monocentric Observational Study
An observational study of Delirium, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to introduce delirium detection and try to determine the prevalence of delirium in Pediatric Intensive Care Unit (PICU) using a validated tool : the Cornell Assessment of Pediatric Delirium (CAPD) for every patient twice a day. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Delirium
- What is being tested?
- CAPD
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2018to 6 Dec 2018
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 0 to 18 years hospitalized in PICU at Necker Children's Hospital
Who may be able to join
- Being hospitalized in PICU during the inclusion period
- Age 0 to 18 years old
Who cannot join
- Patient with a state of sedation that does not allow the assessment of a change in the state of consciousness or cognitive functioning (equivalent score Richmond Agitation-Sedation Scale RASS <-3 or COMFORT B <11)
- Patient or Parental opposition to the observational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Delirium Detection in Pediatric Intensive Care Unit Through a French Translation of the CAPD : a French Monocentric Observational Study
The purpose of this study is to introduce delirium detection and try to determine the prevalence of delirium in Pediatric Intensive Care Unit (PICU) using a validated tool : the Cornell Assessment of Pediatric Delirium (CAPD) for every patient twice a day.
Read the detailed description
Delirium is a frequent affection in ICU. In adult population, its prevalence is 20-50% in non intubated patients and 60-80% in patients under invasive ventilation. It is also frequent in paediatric population, but less diagnosed, whereas it can lead to higher duration stay, higher morbidity, traumatic injuries, acute stress, memory losses and post-traumatic stress syndrome. Since 2016, international guidelines recommend to look for delirium in paediatric population in PICU. There are 3 recommended tools to diagnose this affection: psCAM-ICU (6 months-5 years old), pCAM-ICU (5 years old-18 years old) and CAPD (birth-18 years old).
None of these validated tools have been translated in French.
The principal objective is to study the practicability of twice a day detection of delirium in PICU using the CAPD.
Investigators will first used a validation process to translate the CAPD in French, based on the validation method for psychological questionnaires suggested by Vallerand.
Then they will ask the paramedics to evaluate through the CAPD every consecutive patient/12 hours, every day during their stay in PICU, except for those completely unresponsive or under curare. This systematic evaluation will take place for 2 consecutive months.
For every patient, data will be collected about their age, sexe, term of birth, mental affection status, diagnosis at entry, and daily risk of mortality score, length of stay, ventilation, pain evaluation and treatment, withdrawal evaluation, surroundings, use of hypnotic treatment, steroids, opioids and ketamine.
The secondary aims are to determine the prevalence of delirium with the data collected, to ask whether or not the French version of CAPD has been easily and correctly used, can help to diagnose delirium, and whether investigators can find some associated parameters to delirium.
- Conditions
- Delirium
- Being tested
- CAPD
- Keywords
- Delirium, paediatric intensive care unit, CAPD (Cornell Assessment of Paediatric Delirium), French translation
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPDDiagnostic test
CAPD evaluation every day per 12hours during their stay in PICU
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of delirium in the PICU population
Number of CAPD evaluated > 9 / total number of CAPD evaluated
Measured: 2 months
Secondary outcomes (18)
Applicability of the CAPD by the paramedics
5 questions :
- Whether or not they have already heard about delirium
- Whether or not they know the symptoms of delirium in children and adolescents
- Whether or not they have already been confronted to a state of delirium in the Pediatric Intensive Care Unit
- Whether of not they think it would be useful to have a specific scale to diagnose delirium in the Pediatric Intensive Care Unit
- Whether or not they think it would be feasible to use such a scale regularly in the Pediatric Intensive Care Unit The proposed answers will be Yes, No or I don't know for each question The analysis will be qualitative and quantitative.
Measured: Before inclusion period
Applicability of the CAPD by the paramedics after the 2 months period
The same 5 questions of the pre-test, 5 new closed-ended questions and 3 open-ended questions :
- Whether or not they had difficulties evaluating patients with the CAPD
- How they evaluate the duration of the evaluation by the CAPD
- Whether or not they evaluated the patients with a colleague
- Whether or not they think that the assessment of delirium by the CAPD is relevant among PICU patients
- Whether or not they think that a long-term evaluation of delirium by the CAPD is feasible in this PICU unit
1- If difficulties of evaluating patients with the CAPD : quote the difficulties 2- In which categories of patients do they think that the CAPD in not adapted 3- Comment or suggestions to improve the use of the scale
Measured: 2 months
Use of the CAPD by the paramedics
% of CAPD completed during the 2 months period
Measured: 2 months
Age
Potential associated factors to delirium
Measured: 2 months
Sex
Potential associated factors to delirium
Measured: 2 months
Term of birth
Potential associated factors to delirium
Measured: 2 months
Prior neurological impairment
Potential associated factors to delirium
Measured: 2 months
Diagnosis (motivating hospitalization in intensive care)
Potential associated factors to delirium
Measured: 2 months
Severity score on arrival (PIM 3)
Potential associated factors to delirium. Pediatric Index of Mortality (PIM) 3 is a published and open acces program whith 10 variables about the patients (7 binary variables and 3 quantitative ones), that predicts the death probability of the patient. One evaluation per patient at the admission in the PICU unit.
Measured: 2 months
Daily severity score (PELOD 2)
Potential associated factors to delirium. PELOD 2 (PEdiatric Logistic Organ Dysfunction) is a published and open acces program that includes ten variables corresponding to five organ dysfunctions. It predicts a daily percentage of mortality. One evaluation per day per patient during the PICU unit stay.
Measured: 2 months
Duration of hospitalization
Potential associated factors to delirium
Measured: 2 months
Death or survival of the patient
Potential associated factors to delirium
Measured: 2 months
Mechanical ventilation, non invasive ventilation or spontaneous ventilation
Potential associated factors to delirium
Measured: 2 months
Mechanical ventilation time
Potential associated factors to delirium
Measured: 2 months
Presence of parents
Potential associated factors to delirium
Measured: 2 months
Presence of pain
Potential associated factors to delirium.
Pain was evaluated through the appropriate scale amongst :
- Comfort B (pediatric behavioural scale, ventilated, sedated and/or comatose patient): seven items scored 1 to 5, a total score greater than or equal to 17/35 indicating a state of pain,
- or EVENDOL (behavioural scale for conscious patients between birth and 6 years old): five items scored 0 to 3, a total score greater than or equal to 3/15 indicating a state of pain,
- or FLACC (Face Leg Activity Cry Consolability) (pediatric behavioural scale, usable in patients with cognitive impairment): five items scored 0 to 2, a total score greater than or equal to 3/10 indicating a state of pain,
Patients able to assess pain felt :
- Numerical Scale (for patients over 10 years old) a score greater than or equal to 3/10 indicating a state of pain,
- or Visual Analogue Scale (for patients between 6 and 10 years old), a score greater than or equal to 3/10 indicating a state of pain.
Measured: 2 months
withdrawal or not
Potential associated factors to delirium. Withdrawal was evaluated through the scale WAT-1 (Wthdrawal Assessing tool version 1): ten items scored 0 or 1, and 1 item scored 0 to 2, a total score greater than or equal to 3/12 indicating a state of withdrawal.
Measured: 2 months
Use of benzodiazepines, ketamine, corticosteroids or opioids
Potential associated factors to delirium
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start6 Dec 2018
- Primary completion6 Dec 2018
- Study completion6 Dec 2018
Why it stopped: Abandoned study project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Laure De Saint Blanquat, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954261
- Sponsor's protocol ID
- NI18018J
- Other IDs
- 2018-A00763-52
- Acronym
- DeliReP
- Status last verified
- Mar 2026
- First submitted
- 7 Sep 2018
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Delirium Detection in Pediatric Intensive Care Unit Through a French Translation of the CAPD : a French Monocentric Observational Study
- ClinicalTrials.gov ID
- NCT04954261
- Acronym / sponsor ID
- DeliReP / NI18018J
- Conditions
- Delirium
- Keywords
- Delirium, paediatric intensive care unit, CAPD (Cornell Assessment of Paediatric Delirium), French translation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Abandoned study project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 8 Jul 2021 (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.
The purpose of this study is to introduce delirium detection and try to determine the prevalence of delirium in Pediatric Intensive Care Unit (PICU) using a validated tool : the Cornell Assessment of Pediatric Delirium (CAPD) for every patient twice a day.
Detailed description
Delirium is a frequent affection in ICU. In adult population, its prevalence is 20-50% in non intubated patients and 60-80% in patients under invasive ventilation. It is also frequent in paediatric population, but less diagnosed, whereas it can lead to higher duration stay, higher morbidity, traumatic injuries, acute stress, memory losses and post-traumatic stress syndrome. Since 2016, international guidelines recommend to look for delirium in paediatric population in PICU. There are 3 recommended tools to diagnose this affection: psCAM-ICU (6 months-5 years old), pCAM-ICU (5 years old-18 years old) and CAPD (birth-18 years old).
None of these validated tools have been translated in French.
The principal objective is to study the practicability of twice a day detection of delirium in PICU using the CAPD.
Investigators will first used a validation process to translate the CAPD in French, based on the validation method for psychological questionnaires suggested by Vallerand.
Then they will ask the paramedics to evaluate through the CAPD every consecutive patient/12 hours, every day during their stay in PICU, except for those completely unresponsive or under curare. This systematic evaluation will take place for 2 consecutive months.
For every patient, data will be collected about their age, sexe, term of birth, mental affection status, diagnosis at entry, and daily risk of mortality score, length of stay, ventilation, pain evaluation and treatment, withdrawal evaluation, surroundings, use of hypnotic treatment, steroids, opioids and ketamine.
The secondary aims are to determine the prevalence of delirium with the data collected, to ask whether or not the French version of CAPD has been easily and correctly used, can help to diagnose delirium, and whether investigators can find some associated parameters to delirium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 0 to 18 years hospitalized in PICU at Necker Children's Hospital
Key inclusion criteria (2 listed)
- Being hospitalized in PICU during the inclusion period
- Age 0 to 18 years old
Key exclusion criteria (2 listed)
- Patient with a state of sedation that does not allow the assessment of a change in the state of consciousness or cognitive functioning (equivalent score Richmond Agitation-Sedation Scale RASS <-3 or COMFORT B <11)
- Patient or Parental opposition to the observational 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 |
|---|---|---|
| CAPDCAPD evaluation every day per 12hours during their stay in PICU | Diagnostic test | – |
Primary outcome
Prevalence of delirium in the PICU population
Time frame: 2 months
Number of CAPD evaluated > 9 / total number of CAPD evaluated
18 secondary outcomes
Applicability of the CAPD by the paramedics
Time frame: Before inclusion period
Applicability of the CAPD by the paramedics after the 2 months period
Time frame: 2 months
Use of the CAPD by the paramedics
Time frame: 2 months
Age
Time frame: 2 months
Sex
Time frame: 2 months
Term of birth
Time frame: 2 months
Prior neurological impairment
Time frame: 2 months
Diagnosis (motivating hospitalization in intensive care)
Time frame: 2 months
Severity score on arrival (PIM 3)
Time frame: 2 months
Daily severity score (PELOD 2)
Time frame: 2 months
Duration of hospitalization
Time frame: 2 months
Death or survival of the patient
Time frame: 2 months
Mechanical ventilation, non invasive ventilation or spontaneous ventilation
Time frame: 2 months
Mechanical ventilation time
Time frame: 2 months
Presence of parents
Time frame: 2 months
Presence of pain
Time frame: 2 months
withdrawal or not
Time frame: 2 months
Use of benzodiazepines, ketamine, corticosteroids or opioids
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
Laure De Saint Blanquat, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Prevalence of delirium in the PICU population (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.