HyperbilirubinemiaNCT00383318
Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia
An observational study of Hyperbilirubinemia and Jaundice, run by Pediatrix at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 daysHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Jaundice
- What is being tested?
- Gene mutation sample
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Medical Center
Greenville, South Carolina, 29605
About this study
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.
Read the 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 greater than the 95th percentile based on the Bhutani nomogram) to patients who never developed significant hyperbilirubinemia (bilirubin level in "low risk zone of less than the 40th percentile" on Bhutani nomogram and who did not require any treatment for hyperbilirubinemia). Our primary goal is to determine if common gene mutations occur at a greater frequency in patients with severe hyperbilirubinemia than in neonates without significant hyperbilirubinemia.
The gene mutations we will test for are:
- Glucose-6-phosphate Dehydrogenase Deficiency [G6PD] gene mutations
- African A- mutation (G202A;A376G)
- The common Mediterranean mutation (C563T)
- Two common Chinese mutations (G1376T and G1388A)
- UGT1A1 polymorphism. The UGT1A1 gene polymorphisms refer to those genetic defects found to be associated with Gilbert's Syndrome, including a promoter defect (T-3263G) that disrupts a transcription regulatory site, the TA repeats promoter polymorphism, and four mutations within the coding region (G211A, C686A, C1091T, and T1456G).
- Gene polymorphism for the organic anion transporting protein (OATP-2)
- Conditions
- Hyperbilirubinemia, Jaundice
- Being tested
- Gene mutation sample
- Keywords
- Neonate, Hyperbilirubinemia, Jaundice, G6PD Deficiency, Gilbert's Syndrome
- Medical subject headings
- Hyperbilirubinemia, Jaundice, Glucosephosphate Dehydrogenase Deficiency, Gilbert Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene mutation sampleProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Investigators
- Reese H Clark, MD, Principal investigator, PediatrixZhili Lin, PhD, MD, Principal investigator, Pediatrix ScreeningJon Watchko, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383318
- Sponsor's protocol ID
- PDX 06-001
- Status last verified
- Jan 2008
- First submitted
- 2 Oct 2006
- Last updated
- 28 Jan 2008
- Results posted
- No
Publications
Watchko JF. Vigintiphobia revisited. Pediatrics. 2005 Jun;115(6):1747-53. doi: 10.1542/peds.2004-1748.
PubMed 15930239Bhutani 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.
PubMed 15254556Johnson 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.
PubMed 12006952Ip 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.
PubMed 15231986Watchko 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.
PubMed 19858149
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT00383318
- Acronym / sponsor ID
- PDX 06-001
- Conditions
- Hyperbilirubinemia, Jaundice
- Keywords
- Neonate, Hyperbilirubinemia, Jaundice, G6PD Deficiency, Gilbert's Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 greater than the 95th percentile based on the Bhutani nomogram) to patients who never developed significant hyperbilirubinemia (bilirubin level in "low risk zone of less than the 40th percentile" on Bhutani nomogram and who did not require any treatment for hyperbilirubinemia). Our primary goal is to determine if common gene mutations occur at a greater frequency in patients with severe hyperbilirubinemia than in neonates without significant hyperbilirubinemia.
The gene mutations we will test for are:
- Glucose-6-phosphate Dehydrogenase Deficiency [G6PD] gene mutations
- African A- mutation (G202A;A376G)
- The common Mediterranean mutation (C563T)
- Two common Chinese mutations (G1376T and G1388A)
- UGT1A1 polymorphism. The UGT1A1 gene polymorphisms refer to those genetic defects found to be associated with Gilbert's Syndrome, including a promoter defect (T-3263G) that disrupts a transcription regulatory site, the TA repeats promoter polymorphism, and four mutations within the coding region (G211A, C686A, C1091T, and T1456G).
- Gene polymorphism for the organic anion transporting protein (OATP-2)
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gene mutation sample | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2008.
- Background: PubMed 15930239Watchko JF. Vigintiphobia revisited. Pediatrics. 2005 Jun;115(6):1747-53. doi: 10.1542/peds.2004-1748.
- Background: PubMed 15254556Bhutani 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.
- Background: PubMed 12006952Johnson 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.
- Background: PubMed 15231986Ip 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.
- Derived from this study: PubMed 19858149Watchko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reese H Clark, MD principal investigator
Pediatrix
Zhili Lin, PhD, MD principal investigator
Pediatrix Screening
Jon Watchko, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbilirubinemia and Jaundice, run by Pediatrix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00383318, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2008.