N/A Completed N=642

Validation of the Mercy TAPE

Weight

Source: ClinicalTrials.gov NCT01507090 ↗

Enrolled (actual)

642

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcomePrimary: Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight) — 98.1; 93.3 percentage of participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight)	98.1; 93.3	—
PRIMARY Predictive Performance of the Mercy TAPE (Slope)	0.980; 0.977	—
PRIMARY Predictive Performance of the Mercy TAPE (Intercept)	0.968; 1.019	—
PRIMARY Predictive Performance of the Mercy TAPE (Mean Error)	0.28; 0.22	—
PRIMARY Predictive Performance of the Mercy TAPE (Mean Percentage Error)	1.65; 1.91	—
PRIMARY Predictive Performance of the Mercy TAPE (Corelation Coefficient)	0.979; 0.971	—
PRIMARY Predictive Performance of the Mercy TAPE	3.33; 3.92	—
PRIMARY Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio)	0.998; 0.998	—
PRIMARY Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient)	0.996; 0.993	—
PRIMARY Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%)	91.7; 76.4	—
SECONDARY Inter-rater Reliability for the 2D and 3D Mercy TAPEs.	0.993; 0.980; 0.990	—
SECONDARY Device Print Batch Variability	1.01; 1.02; 1.01; 1.01	—
SECONDARY Predictive Performance of the Mercy Method (Intercept)	1.083	—
SECONDARY Predictive Performance of the Mercy Method (Slope)	0.980	—
SECONDARY Predictive Performance of the Mercy Method (Percent of Participants)	97.3	—
SECONDARY Predictive Performance of the Mercy Method (Mean Error)	0.39	—
SECONDARY Predictive Performance of the Mercy Method (Mean Percentage Error)	1.86	—
SECONDARY Predictive Performance of the Mercy Method	3.55	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01507090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.