Parents' Health-Education Handbook in Preventing Pediatric Urolithiasis FormationLast updated on July 2021
- Recruitment Status
- Estimated Enrollment
- Same as current
- Not Applicable
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
- Younger than 3 years
- Both males and females
Pediatric urolithiasis is a very common disease among Uyghur children of China. Investigators have conducted a cross-sectional survey among children?14 years in Kashgar Region, which is Uyghur concentrated region and lies in southern Xinjiang Uyghur Autonomous Region July to December 2016. The resul...
Pediatric urolithiasis is a very common disease among Uyghur children of China. Investigators have conducted a cross-sectional survey among children?14 years in Kashgar Region, which is Uyghur concentrated region and lies in southern Xinjiang Uyghur Autonomous Region July to December 2016. The results showed that the current prevalence rate of urolithiasis was 1.8% among children ?14 years, while the overall prevalence was 3.6%. The prevalence of urolithiasis for children ?1 year was 5.63%. Binary logistic regression analysis showed that non-breastfeeding, urinary tract infection, with a family history of urolithiasis and excessive sweating were all statistical significantly associated with increased risk of urinary stone. Since most of the risks of urolithiasis among Uyghur children are associated with feeding and living habits, investigators create a Parents' Health-Education Handbook based on these results. This Handbook includes the knowledge of symptoms, hazards, epidemiology, risk factors, therapy, and prevention of pediatric urolithiasis, and also baby's right feeding methods. Investigators use this Handbook to teach newborn's parents to enhance their knowledge of pediatric stone, with a view to change parents' cognition, attitude and behavior of preventing stone formation. This study is designed as an unmatched clusters randomized intervention trial. The aim of this study is to investigate the role of Parents' Health-Education Handbook in preventing pediatric urolithiasis formation. It is conducted in Shufu Count in Kashgar Region of China, which include 171 villages and communities. Investigators define each village or community as a cluster. And these villages and communities are assigned to intervention group or control group by a simple random sampling technique with a rate of 1:1. A total of 86 villages and communities are assigned to intervention group, while 85 villages and communities are assigned to control group. Participants include newborns and their parents. The newborns and their parents are assigned to intervention group or control group as their villages or communities. The incidence (same as prevalence) of urolithiasis was 5.63% for children ?1 year by our former study. The intervention (Parents' Health Education) is considered effective when the incidence decreases more than one half (2.8%) for children when they are 1-year old in this study. So for sample size, we estimate the normal incidence of urolithiasis (?0) is about 5.6% , the incidence will decrease to less than 2.8%(?1) after one year intervention, with ? of 0.05, 1-?=90%, 1052 newborns are required by the formula for each group; considered a predicted of 10% missed follow-up late, and at least 2314 newborns needed in this study.
- NCT #
- Not Provided
- Study Chair: Guohua Zeng, PhD The First Affiliated Hospital of Guangzhou Medical University