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.

Study Overview

• Status: Completed
• Conditions: Neurodevelopmental Disorders
• Intervention / Treatment: Other: admission to pediatric intensive care with mechanical ventilation

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.

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Gorm Greisen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; admission to pediatric intensive care with mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total difficulty score of the SDQ questionnaire	Total difficulty score of the Strengths and Difficulties Questionnaire	2 to 18 years of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of cerebral palsy	cerebral palsy defined as 2 or higher on the GMFCS-scale	2 to 18 years of age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of chronic disease	any disease requiring continued medication and/or medical check-ups	2-18 years
Rate of visual impairment	that cannot be corrected by glasses or blind	2-18 years
Rate of hearing impairment	requiring amplification by hearing aid or deaf	2-18 years

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: gorm greisen, prof, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: VD-2019-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Complex personal data, that cannot meaningfully be reduced to a level that will make re-identification possible

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No