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

Completed

• Conditions: Neurodevelopmental Disorders
• Interventions: Other: admission to pediatric intensive care with mechanical ventilation

• Registration Number: NCT04562935
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

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 Timeline

• Study Start: 2020-09-15
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-24
• Primary Completion: 2021-12-31
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric intensive care	admission to pediatric intensive care with mechanical ventilation	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

Primary Outcome Measures

Name	Time	Method
Total difficulty score of the SDQ questionnaire	2 to 18 years of age	Total difficulty score of the Strengths and Difficulties Questionnaire

Secondary Outcome Measures

Name	Time	Method
Rate of cerebral palsy	2 to 18 years of age	cerebral palsy defined as 2 or higher on the GMFCS-scale

Trial Locations

Locations (1)

Gorm Greisen; 🇩🇰 Copenhagen, Denmark