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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Change in Admissions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Admissions
时间窗: 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.
Change in Weight
时间窗: up to 3 months
Weight will be recorded for the duration of the study to identify points of weight destabilization.
Change in Nutritional Interventions
时间窗: up to 3 months
Recommended nutritional interventions will be recorded and analyzed against the recorded weights to identify any correlations to improved growth.
次要结局
- Parental Satisfaction: survey(Month 3)
研究者
Shao Jiang
Plastic Surgeon
Children's Mercy Hospital Kansas City