Clinical trial NCT04284241: Parents' Health-Education Handbook in Preventing Pediatric Urolithiasis Formation
Official title: Parents' Health-Education Handbook in Preventing Pediatric Urolithiasis in Kashgar Region of China: A Clustered Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urolithiasis
Keywords: Pediatric urolithiasis
Uyghur
Parents'Health-Education Handbook
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 2500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to estimate the role of Parents' Health-Education Handbook in preventing pediatric urolithiasis. This study is designed as an unmatched clusters randomized intervention trial. A total of 171 villages and communities in Shufu Count in Kashgar Region of China are assigned to intervention group or control group by a simple random sampling technique with a rate of 1:1. Newborns and their parents are assigned to intervention group or control group as their villages or communities. And at least 2314 newborns are needed in this study. Participants include newborns and their parents. The baseline of newborns includes demographic data, blood cell analysis, urinary tract ultrasonographic examination. Newborns' parents will be asked to answer a questionnaire which regarding the knowledge, attitudes, and practices (KAP questionnaire, estimated by scores) related to pediatric stone. Parents in intervention group will undergo and active health education by the investigator with " Parents' Health-Education Handbook", while parents in control group are without the program. Newborns are invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately when they are one, two and three years old. Their parents will be asked to answer the same KAP questionnaire at the same time. The incidence of urolithiasis is evaluated and compared between the two groups. Improvement of knowledge, attitudes, and practices (KAP questionnaire) related to pediatric stone of parents are evaluated. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.

Detailed description: 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 (π0) is about 5.6% , the incidence will decrease to less than 2.8%(π1) after one year intervention, with α of 0.05, 1-β=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.

Eligibility criteria: Inclusion Criteria:

1. Full-term newborn (37-42 weeks pregnant) .
2. The weight is ≥2.5 kg at birth.

Exclusion Criteria:

1. Urinary system congenital malformation.
2. Sponge kidney.
3. Hydronephrosis.
4. Ureteropelvic junction obstruction.
5. Hypospadias.
6. Urinary calculi.
7. congenital heart disease.
8. Down syndrome

Primary outcomes:
measure: The incidence of pediatric urolithiasis for the first year.
timeFrame: One year after the child was born.
measure: The incidence of pediatric urolithiasis for the second year.
timeFrame: Two years after the child was born.
measure: The incidence of pediatric urolithiasis for the third year.
timeFrame: Three years after the child was born.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Guohua Zeng, PhD
role: STUDY_CHAIR
References: