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The Weigh Easy System for Cleft Lip and Palate
N/A
Waitlist Available
Led By Shao Jiang, MD
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newborn patient ≤ 12 weeks old
Referred to Children's Mercy Hospital Multidisciplinary Cleft Team from December 1, 2019 - November 30, 2020
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights
Study Summary
This trial will compare weight outcomes of infants with cleft lip and/or palate who use the Weigh Easy system to monitor weight, with those who don't.
Eligible Conditions
- Cleft Lip and Palate
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Admissions
Change in Nutritional Interventions
Change in Weight
Secondary outcome measures
Parental Satisfaction: survey
Trial Design
2Treatment groups
Experimental Treatment
Group I: Retrospective Control ArmExperimental Treatment1 Intervention
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.
Group II: Prospective Weigh EasyExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Children's Mercy Hospital Kansas CityLead Sponsor
244 Previous Clinical Trials
935,776 Total Patients Enrolled
Katherine SheddLead Sponsor
Shao Jiang, MDPrincipal InvestigatorChildren's Mercy Hospital Kansas City
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any individuals being enrolled in this clinical investigation at the moment?
"Reviews of clinicaltrials.gov suggest that this trial launched on October 1st 2020 and is still actively recruiting patients as it underwent its last update on October 5th 2022."
Answered by AI
What is the cap of participants for this research endeavor?
"Affirmative. The clinicaltrials.gov entry for this research effort indicates that it is actively recruiting participants, with 325 individuals being sought from one medical facility since its October 1st 2020 posting date and last edit on the 5th of October 2022."
Answered by AI
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