Efficacy of Yinzhihuang Oral Liquid on Indirect Bilirubin of Neonates With Glucose-6-phosphate Dehydrogenase Deficiency

NCT02594904 | Unknown Phase 4

• 1 other identifier: whuang201500601
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hyperbilirubinemia

Keywords

G6PD Deficiency; Neonatal Hyperbilirubinemia; Yinzhihuang Oral Liquid; Indirect Bilirubin

Outcome Measures

Primary Outcomes (1)

• The change(umol/L) from baseline of total bilirubin(umol/L) will be calculated and finalized

  Value of the total bilirubin in serum(umol/L) will be collected and calculated.

  Every 24 hours during dosing, for around three days.(Typicall the dosing will be stopped once the bilirubin is below 100umol/L)

Secondary Outcomes (1)

• 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)

Study Arms (4)

G-6-PD normal group

EXPERIMENTAL

Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.

Drug: Yinzhihuang Oral Liquid

G-6-PD mild deficiency group

EXPERIMENTAL

Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.

Drug: Yinzhihuang Oral Liquid

G-6-PD moderate deficiency group

EXPERIMENTAL

Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.

Drug: Yinzhihuang Oral Liquid

G-6-PD sever deficiency group

EXPERIMENTAL

Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.

Drug: Yinzhihuang Oral Liquid

Interventions

Yinzhihuang Oral Liquid DRUG

All the four groups will be given same treatment as being described in arm description.

Also known as: Huarun Yinzhihuang Oral solution

G-6-PD mild deficiency group; G-6-PD moderate deficiency group; G-6-PD normal group; G-6-PD sever deficiency group

Eligibility Criteria

• Age: 3 Days - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Southern Medical University, China: lead

Study Sites (1)

The South Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (3)

• Kaplan M, Hammerman C. Glucose-6-phosphate dehydrogenase deficiency and severe neonatal hyperbilirubinemia: a complexity of interactions between genes and environment. Semin Fetal Neonatal Med. 2010 Jun;15(3):148-56. doi: 10.1016/j.siny.2009.10.007. Epub 2009 Nov 26.

  PMID: 19942489 BACKGROUND

• Nkhoma ET, Poole C, Vannappagari V, Hall SA, Beutler E. The global prevalence of glucose-6-phosphate dehydrogenase deficiency: a systematic review and meta-analysis. Blood Cells Mol Dis. 2009 May-Jun;42(3):267-78. doi: 10.1016/j.bcmd.2008.12.005. Epub 2009 Feb 23.

  PMID: 19233695 BACKGROUND

• Clinical Research Collaborative Group of Yinzhihuang Oral Solution. [A multicenter randomized controlled study on the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal indirect hyperbilirubinemia in term newborn infants]. Zhonghua Er Ke Za Zhi. 2011 Sep;49(9):663-8. Chinese.

  PMID: 22176900 BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Glucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Weimin Huang, Ph.D

  The South Hospital of Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weimin Huang, Ph.D

CONTACT

+8613900261113; drhwm2003@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 3, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 3, 2015

Record last verified: 2015-10

Locations

CN (1)