A Multicenter Study to Evaluate the Efficacy of Yinzhihuang Oral Liquid on Indirect Bilirubin of Neonates With Glucose-6-phosphate Dehydrogenase Deficiency
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The change(umol/L) from baseline of total bilirubin(umol/L) will be calculated and finalized
研究概览
简要总结
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.
详细描述
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, low temperature, low protein, low blood sugar, etc. which may lead to bilirubin encephalopathy; (4)History of oxidation drug exposure(e.g. honeysuckle bath) Study procedures： Outpatient and inpatient neonates (mainly for cesarean section newborns), with jaundice after 3-7 days of birth, total bilirubin in serum or measuring bilirubin from skin is between 100umol/L and 257umol/L, will be selected. On the first day of jaundice, the G-6-PD enzyme activity will be detected by checking arterial blood, and then start taking Yinzhihuang oral liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.
When the transcutaneous bilirubin is below 100umol/L, stop taking the medication. When bilirubin increases to match the phototherapy indications, the neonates will be transferred to the neonatal department, and continue the Yinzhihuang oral liquid treatment until bilirubin decreasing to normal level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Note: Icterus testers are Minolta 105 type. Measurements of bilirubin are from three location, inluding forehead, chest and abdomen. The value of bilirubin will use the average value from the three location, and the unit is umol / L.
排除标准
- •Neonates with inherited metabolic diseases;
- •Neonates with congenital malformation of liver and gallbladder;
- •Neonates with asphyxia, hypoxia, acidosis, sepsis, high fever, low temperature, low protein, low blood sugar, etc. which may lead to bilirubin encephalopathy;
- •History of oxidation drug exposure(e.g. honeysuckle bath)
研究组 & 干预措施
G-6-PD normal group
Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.
干预措施: Yinzhihuang Oral Liquid (Drug)
G-6-PD mild deficiency group
Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.
干预措施: Yinzhihuang Oral Liquid (Drug)
G-6-PD moderate deficiency group
Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.
干预措施: Yinzhihuang Oral Liquid (Drug)
G-6-PD sever deficiency group
Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.
干预措施: Yinzhihuang Oral Liquid (Drug)
结局指标
主要结局
The change(umol/L) from baseline of total bilirubin(umol/L) will be calculated and finalized
时间窗: 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.
次要结局
- The percent change(%) from baseline of total bilirubin(umol/L) will be calculated and finalized(Every 24 hours during dosing, for around three days.(Typicall the dosing will be stopped once the bilirubin is below 100umol/L))
研究者
Weimin Huang
Chief physician
Southern Medical University, China