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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04562935
Other study ID # VD-2019-47
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2020
Est. completion date June 30, 2023

Study information

Verified date November 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date June 30, 2023
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
admission to pediatric intensive care with mechanical ventilation
admission to pediatric intensive care with mechanical ventilation

Locations

Country Name City State
Denmark Gorm Greisen Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Rate of learning disability any educational or pedagogical support as reported by parents, more than 9 hours per week 2 to 18 years of age
Other Rate of chronic disease any disease requiring continued medication and/or medical check-ups 2-18 years
Other Rate of visual impairment that cannot be corrected by glasses or blind 2-18 years
Other Rate of hearing impairment requiring amplification by hearing aid or deaf 2-18 years
Primary Total difficulty score of the SDQ questionnaire Total difficulty score of the Strengths and Difficulties Questionnaire 2 to 18 years of age
Secondary Rate of cerebral palsy cerebral palsy defined as 2 or higher on the GMFCS-scale 2 to 18 years of age
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