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Clinical Trials/NCT04562935
NCT04562935
Completed
Not Applicable

Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age

Rigshospitalet, Denmark1 site in 1 country330 target enrollmentSeptember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurodevelopmental Disorders
Sponsor
Rigshospitalet, Denmark
Enrollment
330
Locations
1
Primary Endpoint
Total difficulty score of the SDQ questionnaire
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2020
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gorm Greisen

consultant neonatologist, professor

Rigshospitalet, Denmark

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Total difficulty score of the SDQ questionnaire

Time Frame: 2 to 18 years of age

Total difficulty score of the Strengths and Difficulties Questionnaire

Secondary Outcomes

  • Rate of cerebral palsy(2 to 18 years of age)

Study Sites (1)

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