Weigh Easy: Simplifying Home Weight Monitoring for Infants

Cleft Lip and Palate Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384276
• Other study ID #: STUDY00000822
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Other:
• The 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.
• Retrospective Control
No interventions will be administered to the historical control group.

Locations

Country	Name	City	State
United States	The Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (19)

Avedian LV, Ruberg RL. Impaired weight gain in cleft palate infants. Cleft Palate J. 1980 Jan;17(1):24-6. — View Citation

Barrett, D. E., Radke-Yarrow, M., & Klein, R. E. (1982). Chronic malnutrition and child behavior: Effects of early caloric supplementation on social and emotional functioning at school age. Developmental Psychology, 18(4):541-556. doi:10.1037/0012-1649.18.4.541

Beaumont D. A study into weight gain in infants with cleft lip/palate. Paediatr Nurs. 2008 Jul;20(6):20-3. doi: 10.7748/paed2008.07.20.6.20.c6626. — View Citation

Gregory KE, Radovinsky L. Research strategies that result in optimal data collection from the patient medical record. Appl Nurs Res. 2012 May;25(2):108-16. doi: 10.1016/j.apnr.2010.02.004. Epub 2010 Apr 9. — View Citation

Hartley SL, MacLean WE Jr. A review of the reliability and validity of Likert-type scales for people with intellectual disability. J Intellect Disabil Res. 2006 Nov;50(Pt 11):813-27. doi: 10.1111/j.1365-2788.2006.00844.x. — View Citation

Idohou-Dossou N, Wade S, Guiro AT, Sarr CS, Diaham B, Cisse D, Beau JP, Chappuis P, Hoffman D, Lemonnier D. Nutritional status of preschool Senegalese children: long-term effects of early severe malnutrition. Br J Nutr. 2003 Dec;90(6):1123-32. doi: 10.1079/bjn2003990. — View Citation

Jones WB. Weight gain and feeding in the neonate with cleft: a three-center study. Cleft Palate J. 1988 Oct;25(4):379-84. — View Citation

Kaye A, Thaete K, Snell A, Chesser C, Goldak C, Huff H. Initial Nutritional Assessment of Infants With Cleft Lip and/or Palate: Interventions and Return to Birth Weight. Cleft Palate Craniofac J. 2017 Mar;54(2):127-136. doi: 10.1597/15-163. Epub 2016 Feb 16. — View Citation

Lao LJ, Zhang LY, DU LZ. [Malnutrition in early life and cardiovascular disease in adulthood]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2015 May;44(3):349-53. Chinese. — View Citation

Marques IL, Nackashi JA, Borgo HC, Martinelli AP, Pegoraro-Krook MI, Williams WN, Dutka JC, Seagle MB, Souza TV, Garla LA, Neto JS, Silva ML, Graciano MI, Moorhead J, Piazentin-Penna SH, Feniman MR, Zimmermann MC, Bento-Goncalves CG, Pimentel MC, Boggs S, Jorge JC, Antonelli PJ, Shuster J. Longitudinal study of growth of children with unilateral cleft-lip palate from birth to two years of age. Cleft Palate Craniofac J. 2009 Nov;46(6):603-9. doi: 10.1597/08-105.1. Epub 2009 May 16. — View Citation

Martin V, Greatrex-White S. An evaluation of factors influencing feeding in babies with a cleft palate with and without a cleft lip. J Child Health Care. 2014 Mar;18(1):72-83. doi: 10.1177/1367493512473853. Epub 2013 Feb 25. — View Citation

Montagnoli LC, Barbieri MA, Bettiol H, Marques IL, de Souza L. Growth impairment of children with different types of lip and palate clefts in the first 2 years of life: a cross-sectional study. J Pediatr (Rio J). 2005 Nov-Dec;81(6):461-5. doi: 10.2223/JPED.1420. — View Citation

Pandya AN, Boorman JG. Failure to thrive in babies with cleft lip and palate. Br J Plast Surg. 2001 Sep;54(6):471-5. doi: 10.1054/bjps.2001.3618. — View Citation

Ranalli DN, Mazaheri M. Height-weight growth of cleft children, birth to six years. Cleft Palate J. 1975 Oct;12:400-4. — View Citation

Sawaya AL, Martins PA, Grillo LP, Florencio TT. Long-term effects of early malnutrition on body weight regulation. Nutr Rev. 2004 Jul;62(7 Pt 2):S127-33. doi: 10.1111/j.1753-4887.2004.tb00082.x. — View Citation

Seth AK, McWilliams BJ. Weight gain in children with cleft palate from birth to two years. Cleft Palate J. 1988 Apr;25(2):146-50. — View Citation

Smedegaard L, Marxen D, Moes J, Glassou EN, Scientsan C. Hospitalization, breast-milk feeding, and growth in infants with cleft palate and cleft lip and palate born in Denmark. Cleft Palate Craniofac J. 2008 Nov;45(6):628-32. doi: 10.1597/07-007.1. — View Citation

Strupp BJ, Levitsky DA. Enduring cognitive effects of early malnutrition: a theoretical reappraisal. J Nutr. 1995 Aug;125(8 Suppl):2221S-2232S. doi: 10.1093/jn/125.suppl_8.2221S. — View Citation

Young A. Cleft lip and/or palate. Community Pract. 2009 Jul;82(7):34-5. No abstract available. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Weight will be recorded for the duration of the study to identify points of weight destabilization.	up to 3 months
Primary	Change in Nutritional Interventions	Recommended nutritional interventions will be recorded and analyzed against the recorded weights to identify any correlations to improved growth.	up to 3 months
Primary	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.	up to 3 months
Secondary	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.	Month 3