Intensive Care Unit SyndromeVECUREANCT03828552
Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.
An observational study of Intensive Care Unit Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions, sometimes life-threatening. Thus, priority is given to urgent somatic care, children medicalization is strong, invasive technics have to be used, and medical monitoring is close. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- Questionnaire
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2019to 21 Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parent (mother or /and father) of a recovered child in the PICU for at least 3 days, for a first stay, without limit of age, disease or admission mode.
Who may be able to join
- Parent (mother or /and father) of a recovered child in PICU.
- No limit of age, disease or admission mode.
- First stay in PICU, for at least a 3 days stay.
- Parents having been informed and having accepted the participation in the study.
Who cannot join
- Death of the child during the stay in PICU or during the month following the discharge from PICU
- Non-fluent french speakers/readers.
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric intensive care unit of Women-Mother-Children Hospital
Bron, 69677
About this study
Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions, sometimes life-threatening. Thus, priority is given to urgent somatic care, children medicalization is strong, invasive technics have to be used, and medical monitoring is close.
A stay in PICU often leaves a painful memory to the child and family, and can lead to psychological morbidity such as post-traumatic stress disease.
This study aims to assess parents' experience during their child hospitalization in PICU, and the impact of this stay on the entire family in the following month.
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Parents will be recruited in a Pediatric Resuscitation Department of the Mother and Child Hospital for 3 months. The doctor taking care of a child and his parents meeting the eligibility criteria will distribute, during the stay, a questionnaire accompanied by a pre-stamped envelope to the two parents not opposing the study.
A phone call and / or an email reminder by the intern in the month of the exit will invite each parent to return the questionnaire.
The completed questionnaire will be mailed back by the parents using the pre-stamped envelope.
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyse qualitatively the parents'experience during the PICU stay of their child
Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)
Measured: 1 month
Assessment of the impact on the family of this PICU stay of their child
Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start4 Mar 2019
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828552
- Sponsor's protocol ID
- 69HCL18_0700
- Acronym
- VECUREA
- Status last verified
- Sep 2019
- First submitted
- 25 Jan 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT03828552
- Acronym / sponsor ID
- VECUREA / 69HCL18_0700
- Conditions
- Intensive Care Unit Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 4 Feb 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.
Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions, sometimes life-threatening. Thus, priority is given to urgent somatic care, children medicalization is strong, invasive technics have to be used, and medical monitoring is close.
A stay in PICU often leaves a painful memory to the child and family, and can lead to psychological morbidity such as post-traumatic stress disease.
This study aims to assess parents' experience during their child hospitalization in PICU, and the impact of this stay on the entire family in the following month.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parent (mother or /and father) of a recovered child in the PICU for at least 3 days, for a first stay, without limit of age, disease or admission mode.
Key inclusion criteria (4 listed)
- Parent (mother or /and father) of a recovered child in PICU.
- No limit of age, disease or admission mode.
- First stay in PICU, for at least a 3 days stay.
- Parents having been informed and having accepted the participation in the study.
Key exclusion criteria (2 listed)
- Death of the child during the stay in PICU or during the month following the discharge from PICU
- Non-fluent french speakers/readers.
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 |
|---|---|---|
| QuestionnaireParents will be recruited in a Pediatric Resuscitation Department of the Mother and Child Hospital for 3 months. The doctor taking care of a child and his parents meeting the eligibility criteria will distribute, during the stay, a questionnaire accompanied by a pre-stamped envelope to the two parents not opposing the study. A phone call and / or an email reminder by the intern in the month of the exit will invite each parent to return the questionnaire. The completed questionnaire will be mailed back by the parents using the pre-stamped envelope. | Other | – |
Primary outcome
Analyse qualitatively the parents'experience during the PICU stay of their child
Time frame: 1 month
Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)
Assessment of the impact on the family of this PICU stay of their child
Time frame: 1 month
Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)
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 6 Sep 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intensive Care Unit Syndrome, run by Hospices Civils de Lyon 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 4 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: finished, as of the sponsor's last update on 6 Sep 2019. 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 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?
Analyse qualitatively the parents'experience during the PICU stay of their child (time frame: 1 month). The study lists 2 primary outcomes in all. 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 6 Sep 2019.