Long-term Consequences of Admission for Pediatric Intensi... | NCT04562935

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

NCT04562935

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

330Actual

Phase

Not provided

Conditions

Neurodevelopmental Disorders

Interventions

admission to pediatric intensive care with mechanical ventilation

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2020Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

Sep 15, 2020

First Submission Date that Met QC Criteria

Sep 23, 2020

First Posted Date

Sep 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2023

Last Update Posted Date

Nov 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gorm Greisen, consultant neonatologist, professor, Rigshospitalet, DenmarkPrincipal Investigator

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

330Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
admission to pediatric intensive care with mechanical ventilation	Other	admission to pediatric intensive care with mechanical ventilation	Pediatric intensive care

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children and adolescents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
gorm greisen, prof	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gorm Greisen		Copenhagen		2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Complex personal data, that cannot meaningfully be reduced to a level that will make re-identification possible

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065886	Neurodevelopmental Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012121	Respiration, Artificial

Ancestor Terms

ID	Term
D058109	Airway Management
D013812	Therapeutics
D012151	Resuscitation
D004638	Emergency Treatment

Browse Leaves

Not provided

Browse Branches

Not provided