Early Mobilization: Evaluation of Feasibility and Security in Pediatric Intensive Care Unit

November 7, 2016 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
The purpose of this study is to evaluate the feasibility and the security of early mobilization of infants in pediatric intensive care.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted in pediatric intensive care unit that respond to eligibility criteria

Description

Inclusion Criteria:

  • cardiorespiratory stability
  • between 24 and 48h post admission

Exclusion Criteria:

  • Thorax open
  • ECLS
  • High frequency oscillatory ventilation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory parameters assessed by monitoring
Time Frame: up to 1 hour
cardiac frequency, respiratory frequency, blood pressure
up to 1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
EDIN scale (tool for assessing prolonged pain in preterm and newborns)
Time Frame: 5 minutes before mobilization
5 minutes before mobilization
EDIN scale (tool for assessing prolonged pain in preterm and newborns)
Time Frame: up to 1 hour
up to 1 hour
COMFORT-BEHAVIOR scale (to measure the amount of stress of ventilated infants in a pediatric intensive care unit)
Time Frame: 5 minutes before mobilization
5 minutes before mobilization
COMFORT-BEHAVIOR scale (to measure the amount of stress of ventilated infants in a pediatric intensive care unit)
Time Frame: up to 1 hour
up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

November 7, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • MobpediaSIP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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