Hyperbilirubinaemia
Conditions
Interventions
Experimental group:Live Combined Bacillus Subtilis and Enterococcus Faecium Granules
Control groups:Placebo
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All the newborns are full-term (38 weeks or older) and their birth weight are more than 2500g; 2. In accordance with "neonatal bilirubin hour nomogram" recommended by American AAP guidelines, newborns are enrolled whose blood total serum bilirubin (TSB) 48~72hr after birth range between 40th percentile and the 95th percentile; 3. Informed consent has been signed by guardian of children.
Exclusion criteria
Exclusion criteria: 1. Hemolytic disease of newborn; 2. Asphyxia (more than 7 points 1 minute after birth by apgar score); 3. Hypoxia (SpO2 over 85%); 4. Acidosis; 5. Severe infection; 6. Fever (38 Centegrade or higher); 7. Hypothermia (lower than 36 Centegrade); 8. Newborns with low birth weight (less than 2500g); 9. Hypoproteinemia with albumin less than 3.0g/dl; 10. Hypoglycemia with blood glucose less than 50mg/dl; 11. Mothers with CMV infection; 12. Neonatal hyperbilirubinemia patients who have already received phototherapy; 13. Allergic constitution or allergy to this product ingredients; 14. Patients whose families cannot understand or cannot complete the study and those without legal or insight capacity; 15. Those who participate in other clinical trials in the meanwhile; 16. There are other factors that may affect the test results or subjects who are not suitable for the trial judged by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The value of transcutaneous bilirubin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of cases reaching phototherapy standard;Beta--GD content in stool;The content of fecal urobilinogen;The composition of fecal intestinal flora; | — |
Countries
China
Contacts
Public ContactGuofang Ding
Outcome results
None listed