Status:
COMPLETED
Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia
Lead Sponsor:
Pediatrix
Conditions:
Hyperbilirubinemia
Jaundice
Eligibility:
All Genders
Up to 6 years
Brief 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 bilirubi...
Detailed Description
The purpose of this study is to compare the demographic, metabolic, and genomic characteristics of patients who develop severe hyperbilirubinemia (serum bilirubin level in the "high risk zone of great...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00383318
Start Date
September 1 2006
End Date
December 1 2007
Last Update
January 28 2008
Active Locations (1)
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1
Greenville Medical Center
Greenville, South Carolina, United States, 29605