Neurodevelopmental Disorders Clinical Trial
Official title:
Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age
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 |
Verified date | November 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Gorm Greisen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
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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