Viewing Study NCT00154999



Ignite Creation Date: 2024-05-05 @ 11:52 AM
Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00154999
Status: COMPLETED
Last Update Posted: 2005-11-29
First Post: 2005-09-09

Brief Title: The Predictors of the Neonatal Hyperbilirubinemia
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: The Predictors of the Neonatal Hyperbilirubinemia
Status: COMPLETED
Status Verified Date: 2004-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NTUH-94S128 None None None