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Weigh Easy: Simplifying Home Weight Monitoring for Infants

NCT04384276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2023-01-17

No results posted yet for this study

Summary

This single-site, experimental, pilot study in infants identified from 0 - 3 months of age who present to the Cleft and Craniofacial Clinic with a cleft lip and/or palate will compare weight outcomes of infants who used the Weigh Easy system to monitor weight and historical infants whose weights were monitored without the Weigh Easy system.

Conditions

  • Cleft Lip and Palate

Interventions

OTHER

The Weigh Easy System

By use of a small user-friendly luggage scale, the family can easily and safely obtain a weight within the comfort of their own home. Using the Weigh Easy eClipboard, a message will be sent to the family on a weekly basis via Cerner's Message Center that will include a link. The link will be used by parents to enter and submit the patient's current weight. Upon submission, the weight will be transmitted into the patient's EMR after it's reviewed and accepted by a member of the study team. When the weight is received in the system, an alert will be triggered that will notify the study team of its arrival. While the Weigh Easy eClipboard function does qualify as a device, as the investigators will be making clinical decisions based off of the data received through the form, the device is not being used investigationally on this study. The eClipboard function is a standard part of the Cerner framework and has been previously investigated and vetted by for safety and efficacy.

OTHER

Retrospective Control

No interventions will be administered to the historical control group.

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Shao Jiang, MD · Children's Mercy Hospital Kansas City

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04384276 on ClinicalTrials.gov