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Parents' Health-Education Handbook in Preventing Pediatric Urolithiasis Formation

NCT04284241 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2020-02-25

No results posted yet for this study

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.

Conditions

  • Urolithiasis

Interventions

BEHAVIORAL

Parents'Health-Education Handbook

We created a Parents' Health-Education Handbook to teach the newborns' parents to enhance their knowledge of pediatric stone, with a view to changing parents' cognition, attitude and behavior for preventing pediatric stone formation by this cluster randomized control trail.

Sponsors & Collaborators

  • Guohua Zeng

    lead OTHER

Principal Investigators

  • Guohua Zeng, PhD · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04284241 on ClinicalTrials.gov