Clinical Trial: Efficacy of Yinzhihuang Oral Liquid on Indirect Bilirubin of Neonates With Glucose-6-phosphate Dehydrogenase Deficiency
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multicenter Study to Evaluate the Efficacy of Yinzhihuang Oral Liquid on Indirect Bilirubin of Neonates With Glucose-6-phosphate Dehydrogenase Deficiency
Brief Summary:
Neonatal Glucose-6-phosphate Dehydrogenase(G6PD) Deficiency is one of the significant reason for neonatal hyperbilirubinemia and even irreversible bilirubin encephalopathy.The neonates may be attacked due to acute infection, eating beans or exposure to oxidative drugs, etc.
The main clinical manifestations are hemolytic anemia, and the resulting hyperbilirubinemia. When bilirubin is pretty high in body, bilirubin may spread into brain, and thus cause nervous system damage, and severely affect the prognosis of neonates. Therefore, monitoring and early intervention of jaundice has important significance to prevent further aggravation of jaundice and certain sequelae. Phototherapy and exchange transfusion are mainly suitable methods for severe hyperbilirubinemia, however, patients need to be hospitalized. Yinzhihuang Oral Liquid is a kind of traditional Chinese medicine for jaundice. Many large sample and multicenter clinical studies show that the positive efficacy of Yinzhihuang Oral Liquid in the treatment of neonatal hyperbilirubinemia is exactly confirmed.
The purpose of this study is try to detect the treatment effect of Yinzhihuang Oral Liquid on indirect bilirubin in neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia. Try to provide scientific theories for Yinzhihuang Oral Liquid to treat neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia.
Detailed Summary:
The primary objective is to detect the treatment effect of Yinzhihuang Oral Liquid on indirect bilirubin in neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia. Try to provide scientific theories for Yinzhihuang Oral Liquid to treat neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia.
Study subjects includes neonates with hyperbilirubinemia from five hospitals, who are willing to take Yinzhihuang oral liquid.
Five hospitals are South Hospital of Southern Medical University (primary institute), The Third Affiliated Hospital of Guangzhou medical university, Shenzhen maternal and child health hospital, First Affiliated Hospital of Guangxi Medical University, The maternal and child health hospital of Guangxi Zhuang Autonomous Region Inclusion criteria：
- Full-term newborns with jaundice after 3-7 days of birth, total bilirubin in serum or transcutaneous bilirubin is between 100umol/L and 257umol/L, and start taking Yinzhihuang oral liquid, dose: 3ml per each time, 3 times per each day, during the period, measuring bilirubin from skin one time every 24 hours;
- Gestational age≥37 weeks, birth weight≥2.5Kg, Apgar scores≥8;
- lineal consanguinity are all the native residents from Guangdong or Guangxi;
- The enzyme activity of G-6-PD will be detected and collected from all the neonates subjects;
- Informed consents of all the neonates subjects are needed. Exclusion Criteria： (1) Neonates with inherited metabolic diseases; (2) Neonates with congenital malformation of liver and gallbladder; (3) Neonates with asphyxia, hypoxia, acidosis, sepsis, high fever,
Sponsor: Southern Medical University, China
Current Primary Outcome: The change(umol/L) from baseline of total bilirubin(umol/L) will be calculated and finalized [ Time Frame: Every 24 hours during dosing, for around three days.(Typicall the dosing will be stopped once the bilirubin is below 100umol/L) ]
Value of the total bilirubin in serum(umol/L) will be collected and calculated.
Original Primary Outcome: Same as current
Current Secondary Outcome: The percent change(%) from baseline of total bilirubin(umol/L) will be calculated and finalized [ Time Frame: Every 24 hours during dosing, for around three days.(Typicall the dosing will be stopped once the bilirubin is below 100umol/L) ]
Value of the total bilirubin in serum(umol/L) will be collected and calculated.
Original Secondary Outcome: Same as current
Information By: Southern Medical University, China
Dates:
Date Received: October 28, 2015
Date Started: July 2015
Date Completion: June 2016
Last Updated: October 31, 2015
Last Verified: October 2015
