Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia
Completed
Conditions studied: Hyperbilirubinemia, Jaundice
In brief
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.
Key facts
- Study ID
- NCT00383318
- Run by
- Pediatrix
- People needed
- 450
- Starts
- 2006-09-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2008-01-28
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Greenville Medical Center — Greenville, South Carolina, United States
Full record on ClinicalTrials.gov
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