Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia (NCT00383318) | Clinical Trial Compass
CompletedNot Applicable
Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia
United States450 participantsStarted 2006-09
Plain-language summary
The purpose of this study is to compare the demographic, metabolic, and genomic characteristics of patients who develop severe hyperbilirubinemia to patients who never developed a significant bilirubin level.
Who can participate
Age range6 Days
SexALL
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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 anoma…