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Completed

NCT Number: NCT04384276

Weigh Easy: Simplifying Home Weight Monitoring for Infants

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.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

Up to 12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Weigh Easy System

Other

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.

Retrospective Control

Other

No interventions will be administered to the historical control group.

Primary outcomes

  1. Change in Weight

    Time frame: up to 3 months

    Weight will be recorded for the duration of the study to identify points of weight destabilization.

  2. Change in Nutritional Interventions

    Time frame: up to 3 months

    Recommended nutritional interventions will be recorded and analyzed against the recorded weights to identify any correlations to improved growth.

  3. Change in Admissions

    Time frame: 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 outcomes

  1. Parental Satisfaction: survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Simplifying Home Weight Monitoring for Infants With Cleft Lip and/or Palate Differences to Determine if Use of an In-home Scale Leads to Better Compliance With Weight Monitoring Recommendations

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 12, 2020
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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