CClinicalTrials.gg
CompletedNCT04562935Updated Nov 18, 2023

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

An observational study in Neurodevelopmental Disorders, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Rigshospitalet, Denmark · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
330
Ages
2 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neurodevelopmental Disorders
03

In context

Neurodevelopmental Disorders

332 studies on the registry are indexed under Neurodevelopmental Disorders; 143 are open to participants now.

This study's enrollment of 330 is above the median of 200 across 124 observational studies indexed under Neurodevelopmental Disorders.

Browse Neurodevelopmental Disorders studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children and adolescents

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
330 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Other: admission to pediatric intensive care with mechanical ventilation

Interventions

  • Otheradmission to pediatric intensive care with mechanical ventilation

    admission to pediatric intensive care with mechanical ventilation

06

What researchers measure

Primary outcomes

  1. Total difficulty score of the SDQ questionnaire

    Total difficulty score of the Strengths and Difficulties Questionnaire

    Time frame: 2 to 18 years of age

Secondary outcomes

  1. Rate of cerebral palsy

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

    Time frame: 2 to 18 years of age

Other outcomes

  1. Rate of learning disability

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

    Time frame: 2 to 18 years of age

  2. Rate of chronic disease

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

    Time frame: 2-18 years

  3. Rate of visual impairment

    that cannot be corrected by glasses or blind

    Time frame: 2-18 years

  4. Rate of hearing impairment

    requiring amplification by hearing aid or deaf

    Time frame: 2-18 years

07

Study locations

1 site
  • Gorm Greisen
    Copenhagen, 2100, Denmark
08

References and documents

Individual participant data

Plan to share: No — Complex personal data, that cannot meaningfully be reduced to a level that will make re-identification possible

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04562935
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Gorm Greisen (consultant neonatologist, professor, Rigshospitalet, Denmark) — Principal investigator
First posted
Sep 24, 2020
Start date
Sep 15, 2020
Primary completion
Dec 31, 2021
Completion
Jun 30, 2023
Last update
Nov 18, 2023

Study contacts

gorm greisen, prof
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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