Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia

NCT00383318 | Completed

• 1 other identifier: PDX 06-001
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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 bilirubin level.

Conditions

Hyperbilirubinemia; Jaundice

Keywords

Neonate; Hyperbilirubinemia; Jaundice; G6PD Deficiency; Gilbert's Syndrome

Interventions

Gene mutation sample PROCEDURE

Eligibility Criteria

• Age: Up to 6 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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).

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.

Sponsors & Collaborators

• Pediatrix: lead

Study Sites (1)

Greenville Medical Center

Greenville, South Carolina, 29605, United States

Location

Related Publications (5)

• Watchko JF. Vigintiphobia revisited. Pediatrics. 2005 Jun;115(6):1747-53. doi: 10.1542/peds.2004-1748.

  PMID: 15930239 BACKGROUND

• Bhutani VK, Johnson LH, Jeffrey Maisels M, Newman TB, Phibbs C, Stark AR, Yeargin-Allsopp M. Kernicterus: epidemiological strategies for its prevention through systems-based approaches. J Perinatol. 2004 Oct;24(10):650-62. doi: 10.1038/sj.jp.7211152.

  PMID: 15254556 BACKGROUND

• Johnson LH, Bhutani VK, Brown AK. System-based approach to management of neonatal jaundice and prevention of kernicterus. J Pediatr. 2002 Apr;140(4):396-403. doi: 10.1067/mpd.2002.123098. No abstract available.

  PMID: 12006952 BACKGROUND

• Ip S, Chung M, Kulig J, O'Brien R, Sege R, Glicken S, Maisels MJ, Lau J; American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. An evidence-based review of important issues concerning neonatal hyperbilirubinemia. Pediatrics. 2004 Jul;114(1):e130-53. doi: 10.1542/peds.114.1.e130.

  PMID: 15231986 BACKGROUND

• Watchko JF, Lin Z, Clark RH, Kelleher AS, Walker MW, Spitzer AR; Pediatrix Hyperbilirubinemia Study Group. Complex multifactorial nature of significant hyperbilirubinemia in neonates. Pediatrics. 2009 Nov;124(5):e868-77. doi: 10.1542/peds.2009-0460. Epub 2009 Oct 26.

  PMID: 19858149 DERIVED

MeSH Terms

Conditions

Hyperbilirubinemia; Jaundice; Glucosephosphate Dehydrogenase Deficiency; Gilbert Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperbilirubinemia, Hereditary

Study Officials

• Reese H Clark, MD

  Pediatrix

  PRINCIPAL INVESTIGATOR

• Zhili Lin, PhD, MD

  Pediatrix Screening

  PRINCIPAL INVESTIGATOR

• Jon Watchko, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2006
• First Posted: October 3, 2006
• Study Start: September 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 28, 2008

Record last verified: 2008-01

Locations

US (1)