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

Cardio-Respiratory Distress Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02958124
• Other study ID #: MobpediaSIP
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2016
• Last updated: November 7, 2016
• Start date: September 2016

Study information

• Verified date: November 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Damien Moerman
• Phone: 003227642719
• Email: damien.moerman[@]uclouvain.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility and the security of early mobilization of infants in pediatric intensive care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• cardiorespiratory stability

• between 24 and 48h post admission

Exclusion Criteria:

• Thorax open

• ECLS

• High frequency oscillatory ventilation

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardio-Respiratory Distress

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory parameters assessed by monitoring	cardiac frequency, respiratory frequency, blood pressure	up to 1 hour	Yes
Secondary	EDIN scale (tool for assessing prolonged pain in preterm and newborns)		5 minutes before mobilization	Yes
Secondary	EDIN scale (tool for assessing prolonged pain in preterm and newborns)		up to 1 hour	Yes
Secondary	COMFORT-BEHAVIOR scale (to measure the amount of stress of ventilated infants in a pediatric intensive care unit)		5 minutes before mobilization	Yes
Secondary	COMFORT-BEHAVIOR scale (to measure the amount of stress of ventilated infants in a pediatric intensive care unit)		up to 1 hour	Yes