Creating a screening score for biliary atresia in infants with cholestasis
Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study
This study is trying to create a simple scoring system to help doctors quickly identify biliary atresia in infants with cholestasis so they can start treatment sooner.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 1 Day to 3 Months |
| Sex | All |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT03842150 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a scoring system to effectively screen for biliary atresia (BA) in infants diagnosed with cholestasis. Early diagnosis of BA is crucial for improving survival rates and outcomes, as timely intervention with Kasai portoenterostomy can significantly enhance prognosis. The study will involve infants under 90 days old who present with neonatal cholestasis, and will exclude those with severe congenital malformations or incomplete data. By establishing a reliable screening tool, the study seeks to differentiate BA from other causes of cholestasis at an early stage.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under 90 days old with a clinical diagnosis of neonatal cholestasis.
Not a fit: Patients with severe congenital malformations or those with incomplete data will not benefit from this study.
Why it matters
Potential benefit: If successful, this screening score could lead to earlier diagnosis and treatment of biliary atresia, improving survival rates and long-term health outcomes for affected infants.
How similar studies have performed: While the approach of developing a screening score for biliary atresia is not widely established, similar studies focusing on early diagnosis in pediatric conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Clinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth Exclusion Criteria: Severe congenital malformation Subjects with missing data
Where this trial is running
Shanghai, Shanghai
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yongjun Zhang, doctor
- Email: zhangyongjun@sjtu.edu.cn
- Phone: +8602125078310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.