Hyperbilirubinemia
Conditions
Interventions
Control group (Part 3):None
Case group (Part 3):None
Case group(Part 1):None
Control group(Part 1):None
Study group (Part 2, which is RCT):multimodal approach for neonatal hemolysis
Control group (Part 2, which is RCT):modified traditional protocols for neonatal hemolysis
Sponsors
Women’s Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: Part 1 of the study: 1) gestational age at birth 35+0-41+6 weeks and weight >=2500 grams; 2) Having suffered from "neonatal hyperbilirubinemia" or "neonatal ABO hemolytic jaundice" within 1 week after birth; 3) Diagnosed between 6 and 12 months of age: (based on the first page of the inpatient medical record or the diagnostic search of the outpatient medical record); (1). "Chronic bilirubin encephalopathy" or "kernicterus"; (2). "cerebral palsy" or hearing abnormalities; No clear history of severe hypoxic asphyxia or infection at birth is considered; At the same time, a retrospective medical history clearly records significant hyperbilirubinemia (defined as a TSB > 20 mg/dl or a TSB value within 0.5 mg/dl/hour of the bilirubin rising rate (ROR) > 0.5 mg/dl/hour or the exchange transfusion threshold of 2 mg/dl at the corresponding hour-old age) within 1 week (=2500 g; 2) Children with severe neonatal hyperbilirubinemia; These include: serum total bilirubin (TSB) levels above 20 mg/dl or within the exchange transfusion threshold of 2 mg/dl at any time (i.e., TSB > (exchange transfusion threshold -2) mg/dl) Part III of the study: Population of participants in the second part of this study
Exclusion criteria
Exclusion criteria: Part 1 of the study: 1) Have a definite congenital hereditary metabolic disease, chromosomal or genetic disease, severe malformation; 2) "cerebral palsy" or hearing abnormalities are considered to be related to other traceable diseases other than those related to hyperbilirubinemia in the early postnatal period; 2. The second part of the study: there are definite congenital inherited metabolic diseases, chromosomal or genetic diseases, and severe malformations; 3. Study Part III: Cases of dropouts or loss of primary data related to outcomes during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bilirubin-induced brain injury; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak total serum bilirubin levels (TSB) and reticulocyte (Ret) counts during hospitalization for "hyperbilirubinemia" within 28 days after birth;Peak total serum bilirubin levels (TSB), end tidal carbon monoxide corrected for the ambient carbon monoxide (ETCOc), and reticulocyte (Ret) counts during hospitalization for "hyperbilirubinemia" within 28 days after birth; | — |
Countries
China
Contacts
Public ContactBao Yingying
Women’s Hospital, Zhejiang University School of Medicine
Outcome results
None listed