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: April 11, 2012
Last verified: April 2012
  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

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

Primary Outcome Measures:
  • 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) and evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the weight generated by the Mercy method (kg)


Secondary Outcome Measures:
  • Variability with the Mercy TAPE [ Time Frame: study day 1 ] [ Designated as safety issue: No ]
    Assess intra-rater and inter-rater reliability when using the 2D and 3D Mercy TAPE (intraclass correlation coefficient) and batch-to-batch variability for each TAPE (mean error, mean percentage error, root mean square error)


Enrollment: 625
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
Last Updated: April 11, 2012
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 21, 2014