Clinical trial NCT04384276: Weigh Easy: Simplifying Home Weight Monitoring for Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: Weight Monitoring
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 157
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
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
Primary purpose: OTHER

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.

Eligibility 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Weight
timeFrame: up to 3 months
measure: Change in Nutritional Interventions
timeFrame: up to 3 months
measure: Change in Admissions
timeFrame: up to 3 months
Secondary outcomes:
measure: Parental Satisfaction: survey
timeFrame: Month 3
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Shao Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avedian LV, Ruberg RL. Impaired weight gain in cleft palate infants. Cleft Palate J. 1980 Jan;17(1):24-6.
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
citation: 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.
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.
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.
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.
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.
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.
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. doi: 10.3785/j.issn.1008-9292.2015.05.18. Chinese.
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.
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.
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.
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.
citation: Ranalli DN, Mazaheri M. Height-weight growth of cleft children, birth to six years. Cleft Palate J. 1975 Oct;12:400-4.
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.
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.
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.
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.
citation: Young A. Cleft lip and/or palate. Community Pract. 2009 Jul;82(7):34-5. No abstract available.