NCT00129077

Brief Summary

The purpose of this study is to identify the incidence of scratches on the surface of the eye in children who cannot blink due to medication use and to identify how best to reduce the risk of a scratch on the surface of the eye when patients are using specific medicines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

March 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 10, 2007

Status Verified

July 1, 2007

First QC Date

August 9, 2005

Last Update Submit

July 9, 2007

Conditions

Eye InjuriesCritically Ill

Keywords

Pediatric critical careneuromuscular blocking agentscorneal abrasions

Outcome Measures

Primary Outcomes (1)

  • Development of corneal abrasions

    9 days

Secondary Outcomes (1)

  • Incidence of corneal abrasions

    36 hours

Interventions

plastic wrap over eye & lubrication applied q6 hrsPROCEDURE

Eligibility Criteria

Age2 Weeks - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age greater than 42 weeks post-conceptual age and less than 18 years
  • Anticipated need for neuromuscular blockade therapy for at least 24 hours

You may not qualify if:

  • Use of continuous neuromuscular blockade therapy for more than 36 hours (early intervention study)
  • Past medical history of abnormal blink reflex or incomplete lid closure
  • History of daily eye drop use
  • Facial trauma
  • Alteration in periorbital skin integrity prohibiting eyelid closure or effective creation of a moisture chamber
  • Known allergy to eye lubricant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Eye InjuriesCritical IllnessCorneal Injuries

Condition Hierarchy (Ancestors)

Facial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesEye DiseasesWounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCorneal Diseases

Study Officials

  • Martha AQ Curley, PhD

    Boston Children's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 11, 2005

Study Start

March 1, 2004

Study Completion

December 1, 2006

Last Updated

July 10, 2007

Record last verified: 2007-07

Locations

US(2)