Hyperbilirubinemia, NeonatalNCT00154999
The Predictors of the Neonatal Hyperbilirubinemia
An observational study of Hyperbilirubinemia, Neonatal, run by National Taiwan University Hospital.
Trial summary
The oxygen tension increases more than 3 times from fetus to neonate. The oxidant stress happens. And it will cause the destruction of RBC. So, we propose that the ROS may play an important role of neonatal hyperbilirubinemia. Read more about this study
- Who is it for?
- Ages 0 years to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jun 2005
- 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 0 years to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Health neonate
Who cannot join
- perinatal insults prematurity
About this study
The oxygen tension increases more than 3 times from fetus to neonate. The oxidant stress happens. And it will cause the destruction of RBC. So, we propose that the ROS may play an important role of neonatal hyperbilirubinemia. There is strong association between the bilirubin level and ROS levels at 3 days old in our pilot study.
Read the detailed description
The incidence of neonatal jaundice is higher in Eastern population than western people. The bilirubin comes from the destruction of RBC which heme is released and catabolized. If the bilirubin enters into the brain and deposits in basal ganglion, it will cause apoptosis of the neuronal cells, that is so called kernictrus, which is the major complication of the neonatal jaundice. However, the bilirubin has its own antioxidant protective effect. Many clinical or basic studies tried to find out the relationship of bilirubin and reactive oxygen species (ROS) in recent years.
The American Association of Pediatrics proposed the management principle of neonatal jaundice in 1994. It postponed the management criteria of neonatal jaundice Besides, early discharge (before 48 hour-old) was the trend in many countries. It may be dangerous because the neonatal jaundice appears after 48 hour-old. Whether the criteria and the trend will cause the elevation of the incidence of kernictrus, is always the major concern of clinicians. So, searching factors to predict neonatal hyperbilirubinemia causes the interest of many investigators. The predictors are divided into risk-factor based and normogram based. But they are still not suitable for all populations.
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- hyperbilirubinemia, free radicals, Health neonate
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Natural history
- Time perspective
- Prospective
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hung-Chieh Chou, M.D., Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154999
- Sponsor's protocol ID
- 9361700383
- Other IDs
- NTUH-94S128
- Status last verified
- Mar 2004
- First submitted
- 9 Sep 2005
- Last updated
- 29 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictors of the Neonatal Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT00154999
- Acronym / sponsor ID
- 9361700383
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- hyperbilirubinemia, free radicals, Health neonate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Jun 2005
- First posted
- 12 Sep 2005 (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 oxygen tension increases more than 3 times from fetus to neonate. The oxidant stress happens. And it will cause the destruction of RBC. So, we propose that the ROS may play an important role of neonatal hyperbilirubinemia. There is strong association between the bilirubin level and ROS levels at 3 days old in our pilot study.
Detailed description
The incidence of neonatal jaundice is higher in Eastern population than western people. The bilirubin comes from the destruction of RBC which heme is released and catabolized. If the bilirubin enters into the brain and deposits in basal ganglion, it will cause apoptosis of the neuronal cells, that is so called kernictrus, which is the major complication of the neonatal jaundice. However, the bilirubin has its own antioxidant protective effect. Many clinical or basic studies tried to find out the relationship of bilirubin and reactive oxygen species (ROS) in recent years.
The American Association of Pediatrics proposed the management principle of neonatal jaundice in 1994. It postponed the management criteria of neonatal jaundice Besides, early discharge (before 48 hour-old) was the trend in many countries. It may be dangerous because the neonatal jaundice appears after 48 hour-old. Whether the criteria and the trend will cause the elevation of the incidence of kernictrus, is always the major concern of clinicians. So, searching factors to predict neonatal hyperbilirubinemia causes the interest of many investigators. The predictors are divided into risk-factor based and normogram based. But they are still not suitable for all populations.
Study design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Health neonate
Key exclusion criteria (1 listed)
- perinatal insults prematurity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 29 Nov 2005.
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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.
Hung-Chieh Chou, M.D. study chair
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbilirubinemia, Neonatal, run by National Taiwan University Hospital.
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 1 inclusion and 1 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 29 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
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?
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 29 Nov 2005.