CompletedNot Applicable

Weigh Easy: Simplifying Home Weight Monitoring for Infants

United States157 participantsStarted 2020-10-01

Plain-language 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.

Who can participate

Age range

12 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Exclusion Criteria: * Infant with secondary major birth defect such as heart or abdominal wall defect in addition to cleft condition

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Weight

Timeframe: up to 3 months

Change in Nutritional Interventions

Timeframe: up to 3 months

Change in Admissions

Timeframe: up to 3 months

Trial details

NCT IDNCT04384276

SponsorChildren's Mercy Hospital Kansas City

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Cleft Lip and Palate trials

Plain-language summary

Who can participate

Age range

12 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.