Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT02594904
Eligibility Criteria:
Inclusion Criteria:
1. 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;
2. Gestational age≥37 weeks, birth weight≥2.5Kg, Apgar scores≥8;
3. lineal consanguinity are all the native residents from Guangdong or Guangxi;
4. The enzyme activity of G-6-PD will be detected and collected from all the neonates subjects;
5. 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.
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Days
Maximum Age:
7 Days
Study:
NCT02594904
Study Brief:
Protocol Section:
NCT02594904