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:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT00383318
Eligibility Criteria:
Inclusion Criteria:
Case
* Documentation of informed consent.
* Gestational age greater than or equal to 37 weeks.
* Birth weight greater than or equal to 2000 grams.
* At least one serum bilirubin level that is greater than the 95th percentile ("high risk zone") based on the Bhutani nomogram(1), for the case population.
* Age at enrollment less than 7 days or less than or equal to 168 hours.
* No major anomalies (chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia, or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies).
* Ability to follow subjects transferred to another facility for outcome data.
Control
* Documentation of informed consent.
* Gestational age greater than or equal to 37 weeks.
* Birth weight greater than or equal to 2000 grams.
* At least one estimate of serum bilirubin. Bilirubin level estimated to be less than the 40th percentile ("low risk zone") based on the Bhutani nomogram. While a serum bilirubin in the low risk zone is the preferred method for assessing the bilirubin level, many pediatricians use transcutaneous measure of bilirubin as a screening tool for identifying "low risk" patients. For this reason, we will allow controls to be identified using transcutaneous measurements and collect serum bilirubin levels only as clinically indicated.
* Age at enrollment less than 7 days or less than or equal to 168 hours.
* No major anomalies (chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies).
* Ability to follow subjects transferred to another facility for outcome data.
Exclusion Criteria:
Case and Control
* Gestational age less than 37 weeks.
* Birth weight less than 2000 grams.
* Older than 7 days of age or 168 hours.
* Any major congenital anomalies.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
6 Days
Study:
NCT00383318
Study Brief:
Protocol Section:
NCT00383318