Neonatal Cholestasis
Conditions
Interventions
Intervention group:Oral administration of Yinchen Siwei decoction combined with ursodeoxycholic acid
Control group:Ursodeoxycholic acid was taken orally
Sponsors
Jiangxi Maternal and Child Health Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gestational age less than 34 weeks, and birth weight <=1500g; 2. Delivered in Jiangxi Provincial Maternal and Child Health Care Hospital; 3. For those clinically diagnosed with cholestasis, the diagnostic criteria for cholestasis refer to the 2004 North American Academy of Pediatric Gastroenterology, Hepatology, and Nutrition definition of neonatal cholestasis: When total bilirubin was less than 5 mg/dL, direct bilirubin was more than 1.0mg/dL. When total bilirubin was more than 5 mg/dL, binding bilirubin was more than 20% of total bilirubin; 4. Gestational hypertension, gestational diabetes mellitus, cholestasis and other pregnancy complications and complications were excluded.
Exclusion criteria
Exclusion criteria: 1. Patients with hemolytic disease, genetic metabolic disease and chromosomal abnormality of newborn; 2. Patients who give up treatment due to social factors; 3. Patients with serious congenital defects, such as complex congenital heart disease, congenital digestive tract malformations, and congenital biliary atresia; 4. Combined TORCH infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bile acid;Alanine transaminase;Renal function; | — |
Secondary
| Measure | Time frame |
|---|---|
| The duration of the need for intravenous nutrition;The duration of reach total enteral feeding;Whether abdominal distension occurs;Whether vomiting occurs;Whether diarrhea occurs;Abdominal ultrasound examination (to confirm the presence of cirrhosis);Whether necrotizing enterocolitis occurs; | — |
Countries
China
Contacts
Public ContactTang Wenyan
Jiangxi Maternal and Child Health Hospital
Outcome results
None listed