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

Neurodevelopmental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562935
• Other study ID #: VD-2019-47
• Status: Completed
• Start date: September 15, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurodevelopmental Disorders

Intervention

Other:
• admission to pediatric intensive care with mechanical ventilation
admission to pediatric intensive care with mechanical ventilation

Locations

Country	Name	City	State
Denmark	Gorm Greisen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Rate of chronic disease	any disease requiring continued medication and/or medical check-ups	2-18 years
Other	Rate of visual impairment	that cannot be corrected by glasses or blind	2-18 years
Other	Rate of hearing impairment	requiring amplification by hearing aid or deaf	2-18 years
Primary	Total difficulty score of the SDQ questionnaire	Total difficulty score of the Strengths and Difficulties Questionnaire	2 to 18 years of age
Secondary	Rate of cerebral palsy	cerebral palsy defined as 2 or higher on the GMFCS-scale	2 to 18 years of age