Neurodevelopmental DisordersNCT04562935
Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age
An observational study of Neurodevelopmental Disorders, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the PICU of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- admission to pediatric intensive care with mechanical ventilation
- How many people
- 330 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2020to 30 Jun 2023
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents
Who may be able to join
- Admitted to the PICU of Copenhagen University Hospital between 1st January 2002 to 31st of December 2016
- Age of admission > 28 days, if born > 37 + 0 or have reached the gestational age of > 40 weeks if the child is premature.
- Needing ≥ 2 days ventilator support during the PICU stay
- Valid civil registration number
- Exlusion criteria:
- Death before follow-up
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the PICU of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016.
A link to a questionnaire including the Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment as well as question on current impairments and health, will be sent to parents. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided.
Read the detailed description
This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the pediatric intensive care section of the Department of Neonatology of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016.
The Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment is web-based an hosted on a safe hospital server. The link will be sent to the universat digital post-box that all Danish citizens use for contact to the public authorities. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided. Furthermore, parents will answer questions on chronic illness, motor and sensory handicap, and special pedagogical support in day care institutions and school.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- admission to pediatric intensive care with mechanical ventilation
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
admission to pediatric intensive care with mechanical ventilationOther
admission to pediatric intensive care with mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Pediatric intensive care | Children admitted to a pediatric intensive care unit before one year of age and admitted for to days or more and treated with mechanical ventilation and alive at follow Receives: Other: admission to pediatric intensive care with mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total difficulty score of the SDQ questionnaire
Total difficulty score of the Strengths and Difficulties Questionnaire
Measured: 2 to 18 years of age
Secondary outcomes (1)
Rate of cerebral palsy
cerebral palsy defined as 2 or higher on the GMFCS-scale
Measured: 2 to 18 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start15 Sep 2020
- Primary completion31 Dec 2021
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Retrospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gorm Greisen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- gorm greisen, prof, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562935
- Sponsor's protocol ID
- VD-2019-47
- Status last verified
- Nov 2023
- First submitted
- 15 Sep 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Complex personal data, that cannot meaningfully be reduced to a level that will make re-identification possible
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age
- ClinicalTrials.gov ID
- NCT04562935
- Acronym / sponsor ID
- VD-2019-47
- Conditions
- Neurodevelopmental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 Sep 2020 (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.
This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the PICU of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016.
A link to a questionnaire including the Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment as well as question on current impairments and health, will be sent to parents. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided.
Detailed description
This study is a retrospective cohort study. The PICU children will include all surviving children who were admitted to the pediatric intensive care section of the Department of Neonatology of Copenhagen University Hospital between 1st of January 2002 and 31st of December 2016.
The Strengths-and-Difficulties parental questionnaire evaluating neurodevelopmental- and behavioral impartment is web-based an hosted on a safe hospital server. The link will be sent to the universat digital post-box that all Danish citizens use for contact to the public authorities. For the children aged between 11 and 17 years an additional self-rated questionnaire will be provided. Furthermore, parents will answer questions on chronic illness, motor and sensory handicap, and special pedagogical support in day care institutions and school.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric intensive care | – | Other: admission to pediatric intensive care with mechanical ventilationChildren admitted to a pediatric intensive care unit before one year of age and admitted for to days or more and treated with mechanical ventilation and alive at follow |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents
Key inclusion criteria (6 listed)
- Admitted to the PICU of Copenhagen University Hospital between 1st January 2002 to 31st of December 2016
- Age of admission > 28 days, if born > 37 + 0 or have reached the gestational age of > 40 weeks if the child is premature.
- Needing ≥ 2 days ventilator support during the PICU stay
- Valid civil registration number
- Death before follow-up
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| admission to pediatric intensive care with mechanical ventilationadmission to pediatric intensive care with mechanical ventilation | Other | Pediatric intensive care |
Primary outcome
Total difficulty score of the SDQ questionnaire
Time frame: 2 to 18 years of age
Total difficulty score of the Strengths and Difficulties Questionnaire
1 secondary outcome
Rate of cerebral palsy
Time frame: 2 to 18 years of age
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 18 Nov 2023.
- Individual participant dataSharing planned: No. Complex personal data, that cannot meaningfully be reduced to a level that will make re-identification possible
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Aprepitant for the Treatment of CLIFAHDD
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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.
gorm greisen, prof principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Neurodevelopmental Disorders, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 6 inclusion and 0 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 18 Nov 2023. 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 Denmark. 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?
Total difficulty score of the SDQ questionnaire (time frame: 2 to 18 years of age). 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 18 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.