Children's Sleep in the ICU | NCT02211404

Studies
Children's Sleep in the ICU

NCT02211404

Sponsor

James Hungerford

Status

Completed

Last Update Posted

Oct 21, 2016Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Children Admitted to the Intensive Care Unit

Interventions

Not provided

Countries

Not provided

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

Oct 2016

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

Apr 2014

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Aug 5, 2014

First Submission Date that Met QC Criteria

Aug 5, 2014

First Posted Date

Aug 7, 2014Estimated

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

Oct 19, 2016

Last Update Posted Date

Oct 21, 2016Estimated

Description Module

Brief Summary

Prospective evaluation of sleep in children admitted to the Intensive Care Unit at Nationwide Children's Hospital to determine how children sleep while admitted to the Intensive Care Unit

Detailed Description

Not provided

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

11Actual

Measure	Description	Time Frame
Total Sleep Time		24 Hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient admitted to the Intensive Care Unit, or soon to be admitted to the ICU
Age from 0 days to 17 years 364 days at the time of enrollment
Any patient with anticipated ICU stay of at least overnight with a minimum of 12 hours duration

Exclusion Criteria:

Any patient with Admitted with Traumatic Brain Injury, Admitted with an Active Seizure Disorder, Severe Developmental Delay that might impair normal sleep architecture, Known abnormal EEG, any patient actively receiving Mechanical Ventilation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children admitted to the Intensive Care Unit

Sampling Method

Non-Probability Sample