An observational study in Biliary Atresia, Neonatal Cholestasis and Infantile Hepatitis Syndrome, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 1 Day to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational
Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. In this study, the investigators aim to develop and validate a scoring system to screen BA in infants with cholestasis.
77 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.
This study's planned enrollment of 400 is above the median of 123 across 32 observational studies indexed under Biliary Atresia.
Browse Biliary Atresia studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
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infants with cholestasis inclduing biliary atresia
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Clinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth
Exclusion Criteria:
Severe congenital malformation Subjects with missing data
Diagnostic Test: biliary atresia screen score
Diagnostic Test: biliary atresia screen score
The investigators aim to develop a scoring system according to clinical, laboratory, imaging features of biliary atresia in the derivation dataset and tested in the validation datasets.
Development and Validation a Screening Score for the biliary atresia in infantile cholestasis
Developed a scoring system according to clinical, laboratory, imaging features of BA and test it in the clinical work. The score system might including clay stool, γ-glutamyl transpeptadase, the results of ultrasound and subscales selected for logistic regression. The total score would sum all the subscales up.The investigators grade the patients with the cholestasis screen score to identify patients with biliary atresia. Patients with score ≤ 15 points considered to be the low-risk group, and patients with risk score \> 15 points considered the high-risk group, and the score model has no maximum or minimum value.
Time frame: 1 weeks
Plan to share: Undecided — The investigators plan to share all the individual participant data information available to our cooperative hospitals through emails
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →