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Completed

NCT Number: NCT04562935

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

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.

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Key information

Conditions

Neurodevelopmental Disorders Mental Disorders

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gorm Greisen

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

admission to pediatric intensive care with mechanical ventilation

Other

admission to pediatric intensive care with mechanical ventilation

Primary outcomes

  1. 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

  1. Rate of cerebral palsy

    Time frame: 2 to 18 years of age

    cerebral palsy defined as 2 or higher on the GMFCS-scale

Other outcomes

  1. Rate of learning disability

    Time frame: 2 to 18 years of age

    any educational or pedagogical support as reported by parents, more than 9 hours per week

  2. Rate of chronic disease

    Time frame: 2-18 years

    any disease requiring continued medication and/or medical check-ups

  3. Rate of visual impairment

    Time frame: 2-18 years

    that cannot be corrected by glasses or blind

  4. Rate of hearing impairment

    Time frame: 2-18 years

    requiring amplification by hearing aid or deaf

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Sep 24, 2020
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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