Parents' Health-Education Handbook in Preventing Pediatric Urolithiasis Formation
Parents' Health-Education Handbook in Preventing Pediatric Urolithiasis Formation
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.
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.
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