Validation of the Mercy TAPE

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01507090
• Date of registration: 04/01/2012
• Prospective Registration: Yes
• Primary sponsor: Susan Abdel-Rahman
• Public title: Validation of the Mercy TAPE TAPE
• Scientific title: Taking the Guesswork Out of Pediatric Weight Estimation (TAPE): Validation of the Mercy TAPE
• Date of first enrolment: February 2012
• Target sample size: 642
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01507090
• Study type: Observational
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Susan Abdel-Rahman, Pharm.D
• Affiliation: Childrens Mercy Hospital

Key inclusion & exclusion 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



Age minimum: 2 Months
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Weight

Intervention(s)

Device: Mercy TAPE

Primary Outcome(s)

Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio) [Time Frame: study day 1]

Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight) [Time Frame: study day 1]

Predictive Performance of the Mercy TAPE (Mean Error) [Time Frame: study day 1]

Predictive Performance of the Mercy TAPE (Slope) [Time Frame: study day 1]

Predictive Performance of the Mercy TAPE (Corelation Coefficient) [Time Frame: study day 1]

Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient) [Time Frame: study day 1]

Predictive Performance of the Mercy TAPE [Time Frame: study day 1]

Predictive Performance of the Mercy TAPE (Mean Percentage Error) [Time Frame: study day 1]

Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%) [Time Frame: study day 1]

Predictive Performance of the Mercy TAPE (Intercept) [Time Frame: study day 1]

Secondary Outcome(s)

Predictive Performance of the Mercy Method [Time Frame: study day 1]

Predictive Performance of the Mercy Method (Intercept) [Time Frame: study day 1]

Predictive Performance of the Mercy Method (Mean Error) [Time Frame: study day 1]

Predictive Performance of the Mercy Method (Percent of Participants) [Time Frame: study day 1]

Device Print Batch Variability [Time Frame: study day 1]

Inter-rater Reliability for the 2D and 3D Mercy TAPEs. [Time Frame: study day 1]

Predictive Performance of the Mercy Method (Mean Percentage Error) [Time Frame: study day 1]

Predictive Performance of the Mercy Method (Slope) [Time Frame: study day 1]

Secondary ID(s)

Mercy TAPE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Results

• Results available: Yes
• Date Posted: 10/02/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01507090