NCT01785017

Brief Summary

A Standardized Clinical Assessment Management Plan (SCAMP) has been developed and implemented at Boston Children Hospital to decrease variations in clinical practice in critical asthma therapies for children. The primary aim is to determine whether a Critical Asthma SCAMP can improve clinical outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 5, 2017

Status Verified

February 1, 2013

Enrollment Period

3.9 years

First QC Date

January 31, 2013

Last Update Submit

January 4, 2017

Conditions

ChildrenAsthma

Keywords

criticalasthmachildren

Outcome Measures

Primary Outcomes (1)

  • Time from initialization of continuous albuterol to time of final every 2 hr albuterol nebulization

    The time to intermittent q2 hr albuterol nebulization from continuous albuterol during hospitalization within 30 days

Study Arms (1)

Chidren with critical asthma

Pre- and post-SCAMP

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized children 2 years and older requiring intensive care treatment for asthma

You may qualify if:

  • Hospitalized patients 2 years and older requiring critical asthma therapies including continuous albuterol nebulization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jackson Wong, MD

    Boston Children Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 6, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 5, 2017

Record last verified: 2013-02

Locations

US(1)