Validation of the Mercy TAPE

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Abdel-Rahman, Children's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier:
NCT01507090
First received: January 4, 2012
Last updated: February 6, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Weight
Device: Mercy TAPE

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Taking the Guesswork Out of Pediatric Weight Estimation (TAPE): Validation of the Mercy TAPE

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    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.

  • Predictive Performance of the Mercy TAPE (Slope) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    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.

  • Predictive Performance of the Mercy TAPE (Intercept) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    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.

  • Predictive Performance of the Mercy TAPE (Mean Error) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

  • Predictive Performance of the Mercy TAPE (Mean Percentage Error) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

  • Predictive Performance of the Mercy TAPE (Corelation Coefficient) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

  • Predictive Performance of the Mercy TAPE [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

  • Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    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.

  • Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    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.

  • Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Inter-rater Reliability for the 2D and 3D Mercy TAPEs. [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Intraclass correlation coefficient

  • Device Print Batch Variability [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Geometric mean of the ratio (CV) of true to estimated weight calculated by TAPE version. Mercy TAPEs were printed in 2 batches numbers "1" and "2" accordingly.

  • Predictive Performance of the Mercy Method (Intercept) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

  • Predictive Performance of the Mercy Method (Slope) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

  • Predictive Performance of the Mercy Method (Percent of Participants) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg). The outcome measure below relfects the percent of participants with weight estimated within within 20% of actual weight.

  • Predictive Performance of the Mercy Method (Mean Error) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

  • Predictive Performance of the Mercy Method (Mean Percentage Error) [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)

  • Predictive Performance of the Mercy Method [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)


Enrollment: 642
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Normal Children
Otherwise healthy children 2 months to 16 years of age.
Device: Mercy TAPE
2D Mercy TAPE and 3D Mercy TAPE

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Normal healthy children

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • In the opinion of the physicians providing patient care and those conducting the study, there are real or perceived contraindications for inclusion as a participant in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507090

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72202
United States, Missouri
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108
United States, Pennsylvania
Milton Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Susan Abdel-Rahman
Investigators
Principal Investigator: Susan Abdel-Rahman, Pharm.D Childrens Mercy Hospital
  More Information

No publications provided by Children's Mercy Hospital Kansas City

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan Abdel-Rahman, Professor of Pediatrics, Children's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT01507090     History of Changes
Other Study ID Numbers: Mercy TAPE
Study First Received: January 4, 2012
Results First Received: July 22, 2014
Last Updated: February 6, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Mercy Hospital Kansas City:
children for whom there is no scale to determine weight

ClinicalTrials.gov processed this record on August 30, 2015