Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Predictors of the Neonatal Hyperbilirubinemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00154999
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 29, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief 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. There is strong association between the bilirubin level and ROS levels at 3 days old in our pilot study.

Condition or disease
Hyperbilirubinemia, Neonatal

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.

Layout table for study information
Study Type : Observational
Enrollment : 100 participants
Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: The Predictors of the Neonatal Hyperbilirubinemia
Study Start Date : April 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health neonate

Exclusion Criteria:

  • perinatal insults prematurity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154999


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Study Chair: Hung-Chieh Chou, M.D. National Taiwan University Hospital
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00154999    
Other Study ID Numbers: 9361700383
NTUH-94S128
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 29, 2005
Last Verified: March 2004
Keywords provided by National Taiwan University Hospital:
hyperbilirubinemia
free radicals
Health neonate
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperbilirubinemia, Neonatal
Hyperbilirubinemia
Pathologic Processes
Infant, Newborn, Diseases