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

NCT ID: NCT04562935

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-15

Study Completion Date

2023-06-30

Brief Summary

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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

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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

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Neurodevelopmental Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

admission to pediatric intensive care with mechanical ventilation

Intervention Type OTHER

admission to pediatric intensive care with mechanical ventilation

Interventions

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admission to pediatric intensive care with mechanical ventilation

admission to pediatric intensive care with mechanical ventilation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Gorm Greisen

consultant neonatologist, professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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gorm greisen, prof

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Gorm Greisen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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VD-2019-47

Identifier Type: -

Identifier Source: org_study_id

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