NCT02958124

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

September 14, 2016

Last Update Submit

November 7, 2016

Conditions

Cardio-Respiratory Distress

Outcome Measures

Primary Outcomes (1)

  • Respiratory parameters assessed by monitoring

    cardiac frequency, respiratory frequency, blood pressure

    up to 1 hour

Secondary Outcomes (4)

  • EDIN scale (tool for assessing prolonged pain in preterm and newborns)

    5 minutes before mobilization

  • EDIN scale (tool for assessing prolonged pain in preterm and newborns)

    up to 1 hour

  • COMFORT-BEHAVIOR scale (to measure the amount of stress of ventilated infants in a pediatric intensive care unit)

    5 minutes before mobilization

  • COMFORT-BEHAVIOR scale (to measure the amount of stress of ventilated infants in a pediatric intensive care unit)

    up to 1 hour

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • cardiorespiratory stability
  • between 24 and 48h post admission

You may not qualify if:

  • Thorax open
  • ECLS
  • High frequency oscillatory ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (1)

  • Piva TC, Ferrari RS, Schaan CW. Early mobilization protocols for critically ill pediatric patients: systematic review. Rev Bras Ter Intensiva. 2019 Jun 10;31(2):248-257. doi: 10.5935/0103-507X.20190038.

    PMID: 31215603DERIVED

Central Study Contacts

Damien Moerman

CONTACT

003227642719damien.moerman@uclouvain.be

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

November 8, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

BE(1)