Parents' Health-Education Handbook in Preventing Pediatric Urolithiasis Formation

NCT04284241 | Unknown

• 1 other identifier: MRER(72)2017
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis

Keywords

Pediatric urolithiasis; Uyghur; Parents'Health-Education Handbook

Outcome Measures

Primary Outcomes (3)

• The incidence of pediatric urolithiasis for the first year.

  When kids are one year old, they will be invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately. If stone is found by ultrasound, low dose urinary CT scan is invited to done. Their parents will be asked to answer the same KAP questionnaire as baseline each time. The incidence of urolithiasis is evaluated and compared between intervention and control groups. Improvement (estimated by scores in KAP questionnaire) of knowledge, attitudes, and practice related to pediatric stone of parents are estimated and compared between two groups. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.

  One year after the child was born.

• The incidence of pediatric urolithiasis for the second year.

  When kids are two years old, they will be invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately. If stone is found by ultrasound, low dose urinary CT scan is invited to done. Their parents will be asked to answer the same KAP questionnaire as former. The incidence of urolithiasis is evaluated and compared between intervention and control groups. Improvement (estimated by scores in KAP questionnaire) of knowledge, attitudes, and practice related to pediatric stone of parents are estimated and compared between two groups. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.

  Two years after the child was born.

• The incidence of pediatric urolithiasis for the third year.

  When kids are three years old, they will be invited to undergo blood cell analysis, urine analysis and urinary tract ultrasonographic examination separately. If stone is found by ultrasound, low dose urinary CT scan is invited to done. Their parents will be asked to answer the same KAP questionnaire as former. The incidence of urolithiasis is evaluated and compared between intervention and control groups. Improvement (estimated by scores in KAP questionnaire) of knowledge, attitudes, and practice related to pediatric stone of parents are estimated and compared between two groups. Association between urolithiasis incidence and improvement of scores in KAP questionnaire are evaluated.

  Three years after the child was born.

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants include newborns and their parents. The baseline of newborns includes demographic data, blood cell analysis, urinary tract ultrasonographic examination. Parents will be asked to answer a questionnaire which regarding the knowledge, attitudes, and practices (KAP questionnaire) related to pediatric stone. Parents also undergo and active health education by the investigator with the " Parents' Health-Education Handbook", and Handbook will be given to them. Handbook includes the knowledge of symptoms, hazards, epidemiology, risk factors, therapy, and prevention of pediatric urolithiasis, and also baby's right feeding methods. Follow up is made every year in the first three years, and the program is done as the baseline.

Behavioral: Parents'Health-Education Handbook

Control group

NO INTERVENTION

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) related to pediatric stone. But parents do not undergo active health education. And Handbook will not be given to them. However, a poster which has the same content as the Handbook is normally displayed in the maternity ward. Parents have the opportunity to see the poster, but without any special remind. Follow up is made every year in the first three years, and the program is done as the baseline.

Interventions

Parents'Health-Education Handbook BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Urinary system congenital malformation.
• Sponge kidney.
• Hydronephrosis.
• Ureteropelvic junction obstruction.
• Hypospadias.
• Urinary calculi.
• congenital heart disease.
• Down syndrome

Sponsors & Collaborators

• Guohua Zeng: lead

Study Sites (1)

epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Guohua Zeng, PhD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Guohua Zeng, PhD

CONTACT

+86 13802916676; gzgyzgh@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-president

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: February 25, 2020
• Study Start: November 20, 2017
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

CN (1)