An interventional study of The Weigh Easy System and Retrospective Control in Cleft Lip and Palate, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged Up to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Other
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.
Patients will be recruited at the earliest possible visit to the Cleft and Craniofacial Clinic. At this visit, families will complete the consent process. After consent is obtained, the study team will ensure that the family is signed up for the Patient Portal and will provide a demonstration of how to safely obtain a weight using the Weigh Easy scale and the infant's car seat. In addition to the luggage scale, a handout will also be sent home with the family, including instructions and safety tips for weighing their infant and instructions for submitting a weight via the Patient Portal.
Families will be asked to submit a weight, obtained with the Weigh Easy scale, via the Weigh Easy eClipboard message on a weekly basis for 3 months.
Three months after the family is enrolled onto the study, the family will be provided the Parental Satisfaction Survey to complete. This will occur at a clinic visit, in the event that a standard of care visit occurs within the window for the visit. If a clinic visit is unavailable, the surveys will be emailed to the family and three reminders will be sent if the survey is not completed in a timely manner.
162 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's enrollment of 157 is above the median of 30 across 114 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Prospective Group:
Inclusion Criteria:
Exclusion Criteria:
Retrospective Group:
Inclusion Criteria:
Exclusion Criteria:
Patients enrolled onto this arm of the study will use the Weigh Easy system for weight tracking in the first three months of life. Weights will be measured in home using the Weigh Easy scale and transmitted to the study team via the Weigh Easy eClipboard message. A notification scheme will be activated for weights found to have plateaued or decreased to ensure that the infant's standard of care nutritionist and provider are able to follow up and recommend additional interventions to counteract the weight change. After three months, families will complete a satisfaction survey to determine if the Weigh Easy system was preferable or if there are any improvements that could be made. All other aspects of the patients' care will follow the standard of care for cleft and craniofacial diagnoses and will be guided by the nutritionists specializing in cleft and craniofacial care.
Other: The Weigh Easy System
Patients enrolled onto the control arm will have retrospectively presented to the Cleft and Craniofacial Clinic from January 1, 2016 to December 31, 2018 as infants. These patients were treated with the standard of care for cleft and craniofacial diagnoses and were followed by the nutritionists specializing in cleft and craniofacial care.
Other: Retrospective Control
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.
No interventions will be administered to the historical control group.
Change in Weight
Weight will be recorded for the duration of the study to identify points of weight destabilization.
Time frame: up to 3 months
Change in Nutritional Interventions
Recommended nutritional interventions will be recorded and analyzed against the recorded weights to identify any correlations to improved growth.
Time frame: up to 3 months
Change in Admissions
Number of admission due to feeding problems or failure to thrive will be analyzed by comparing the number and frequency of admissions between the retrospective and prospective cohorts.
Time frame: up to 3 months
Parental Satisfaction: survey
The Weigh Easy Parental Satisfaction Survey will be used to create a satisfaction score for each family participating. Answers to this survey will be built using a five-point Likert scale. Minimum score: 4, Maximum score: 20, with higher scores indicating lower parental satisfaction. The survey will be administered at a standard of care appointment three months after enrollment (± 1 month) or via email if an appointment is unavailable during this window. This variable will be measured for the prospective cohort only.
Time frame: Month 3
Plan to share: No — De-identified individual patient data only can be shared with other researchers, however the necessary contracting will be needed prior to any data can be shared.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Children's Mercy Hospital Kansas City