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

NCT04562935 | Completed

• 1 other identifier: VD-2019-47
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

• Total difficulty score of the SDQ questionnaire

  Total difficulty score of the Strengths and Difficulties Questionnaire

  2 to 18 years of age

Secondary Outcomes (1)

• Rate of cerebral palsy

  2 to 18 years of age

Other Outcomes (4)

• Rate of learning disability

  2 to 18 years of age

• Rate of chronic disease

  2-18 years

• Rate of visual impairment

  2-18 years

Study Arms (1)

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

admission to pediatric intensive care with mechanical ventilation OTHER

admission to pediatric intensive care with mechanical ventilation

Pediatric intensive care

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents

You may qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Gorm Greisen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• gorm greisen, prof

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant neonatologist, professor

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 24, 2020
• Study Start: September 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)