Cleft Lip and Palate
Conditions
Keywords
Weight Monitoring
Brief 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.
Detailed description
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.
Interventions
OTHERThe 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.
OTHERRetrospective Control
No interventions will be administered to the historical control group.
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A single experimental group will be enrolled prospectively to use the Weigh Easy system. Due to the potential impacts of weight gain within this patient population and the lifelong implications of early malnutrition, we do not feel we can safely randomize a prospective control group. As a result, a retrospective control group will be enrolled to enable a comparison of outcomes between those families using the Weigh Easy system and those who did not. All patients, both retrospective and prospective, will be treated according to the standard cleft lip and/or palate treatment protocols and followed by the registered nutritionists who routinely participate in the Cleft and Craniofacial Clinic
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
Prospective Group: Inclusion Criteria: * Newborn patient ≤ 12 weeks old * Referred to Children's Mercy Hospital Multidisciplinary Cleft Team from December 1, 2019 - November 30, 2020 * With a diagnosis of cleft lip and/or cleft palate * Male or female infant of any ethnic background
Exclusion criteria
* Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition * Infant who is placed in foster care prior to or during the applicable study period * Patient parents unable to complete an electronic survey. * Patient parents unable to speak and read Spanish or English. Retrospective Group: Inclusion Criteria: * Newborn patient ≤ 12 weeks old * Referred to Children's Mercy Hospital Multidisciplinary Cleft Team from January 1, 2016 to June 30, 2019 * With a diagnosis of cleft lip and/or cleft palate * Male or female infant of any ethnic background
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | up to 3 months | Weight will be recorded for the duration of the study to identify points of weight destabilization. |
| Change in Nutritional Interventions | up to 3 months | Recommended nutritional interventions will be recorded and analyzed against the recorded weights to identify any correlations to improved growth. |
| Change in Admissions | up to 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Satisfaction: survey | Month 3 | 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. |
Countries
United States
Outcome results
None listed