NCT01507090

Brief Summary

In 'real-world' health care settings there exist a number of circumstances where the weight of a child is desirable or even necessary but unavailable. Numerous weight estimation strategies have been described but each has limitations. Investigators at Children's Mercy Hospitals and Clinics recently developed a weight estimation method and tool that addresses the limitations of previously published methods. This study is intended to validate the device in a population of children 2 months to 16 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
642

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

January 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

February 10, 2015

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

29 days

First QC Date

January 4, 2012

Results QC Date

July 22, 2014

Last Update Submit

February 6, 2015

Conditions

Weight

Keywords

children for whom there is no scale to determine weight

Outcome Measures

Primary Outcomes (10)

  • Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight)

    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the percentage of participants whose weight estimations using the Mercy TAPEs are within 20% of their actual weight.

    study day 1

  • Predictive Performance of the Mercy TAPE (Slope)

    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the slope of the regression equation comparing observed vs. predicted weight.

    study day 1

  • Predictive Performance of the Mercy TAPE (Intercept)

    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the intercept of the regression equation comparing observed vs. predicted weight.

    study day 1

  • Predictive Performance of the Mercy TAPE (Mean Error)

    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

    study day 1

  • Predictive Performance of the Mercy TAPE (Mean Percentage Error)

    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

    study day 1

  • Predictive Performance of the Mercy TAPE (Corelation Coefficient)

    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

    study day 1

  • Predictive Performance of the Mercy TAPE

    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

    study day 1

  • Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio)

    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the slope of the regression equation comparing method predicted vs. TAPE predicted weight.

    study day 1

  • Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient)

    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the intercept of the regression equation comparing method predicted vs. TAPE predicted weight.

    study day 1

  • Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%)

    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the percentage weight estimations using the Mercy TAPEs that are within 10% of the weight estimations using the Mercy Method.

    study day 1

Secondary Outcomes (8)

  • Inter-rater Reliability for the 2D and 3D Mercy TAPEs.

    study day 1

  • Device Print Batch Variability

    study day 1

  • Predictive Performance of the Mercy Method (Intercept)

    study day 1

  • Predictive Performance of the Mercy Method (Slope)

    study day 1

  • Predictive Performance of the Mercy Method (Percent of Participants)

    study day 1

  • +3 more secondary outcomes

Study Arms (1)

Normal Children

Otherwise healthy children 2 months to 16 years of age.

Device: Mercy TAPE

Interventions

Mercy TAPEDEVICE

2D Mercy TAPE and 3D Mercy TAPE

Normal Children

Eligibility Criteria

Age2 Months - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Normal healthy children

You may qualify if:

  • age between 2 months and 16 years of age
  • capable of having the measurements performed
  • parent or legal guardian is willing and able to provide verbal permission and, when appropriate, the participant has provided verbal assent to participate.

You may not qualify if:

  • unwilling to participate in the study procedures
  • known or apparent limb deformities
  • presence of any external medical equipment attached to the child
  • underlying pathological condition that would produce abnormal body composition for age (e.g. edema)
  • underlying pharmacologic management that would produce abnormal body composition for age (e.g. chronic oral corticosteroid use)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

Location

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location

Milton Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Abdel-Rahman SM, Paul IM, James LP, Lewandowski A; Best Pharmaceuticals for Children Act-Pediatric Trials Network. Evaluation of the Mercy TAPE: performance against the standard for pediatric weight estimation. Ann Emerg Med. 2013 Oct;62(4):332-339.e6. doi: 10.1016/j.annemergmed.2013.02.021. Epub 2013 Apr 17.

    PMID: 23602655DERIVED

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Principal Investigator
Organization
Children's Mercy Hospital
srahman@cmh.edu
816-234-3059

Study Officials

  • Susan Abdel-Rahman, Pharm.D

    Childrens Mercy Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 10, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

February 10, 2015

Results First Posted

February 10, 2015

Record last verified: 2015-02

Locations

US(3)