Clinical Trial: Transcutaneous Bilirubinometers in the Community

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Transcutaneous Bilirubinometers in the Community and the Reduction of Morbidity Associated to Jaundice: A Clustered Randomized Controlled Trial.

Brief Summary: Jaundice is the most frequent reason for readmission for healthy newborns after discharge from the nursery. In the Capital Health area, around 2.5% (315 babies in 2005) of all healthy newborns were admitted to the hospital for jaundice. Although jaundice is very common, it is not always a benign condition. If left untreated, it can have devastating consequences including cerebral palsy and hearing loss. It is therefore critical to be able to identify the newborns at risk for severe jaundice. So far, heel puncture of blood collection has been the traditional method to monitor jaundice in newborns. This causes pain to infants, generates anxiety in parents, and consumes significant health care resources. The aim of this study is to evaluate the efficacy of a new and noninvasive screening tool, the transcutaneous bilirubinometer, in detecting babies in our communities who require hospital readmission. This study will demonstrate whether incorporating transcutaneous bilirubinometer in the home care program delivered by nurses of Healthy Beginning allows the early detection of babies at risk of developing severe jaundice at a lower cost and with less discomfort.

Detailed Summary:
Sponsor: University of Alberta

Current Primary Outcome: Percentage of neonates with at least one serum bilirubin measurement over the 95th percentile, i.e. 350 micromoles/L after 48 hours of age. [ Time Frame: From discharge home to 15 days of age ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of serum bilirubin assessments, number of readmissions, length of admissions, highest level of bilirubin attained, and severity of treatment required [ Time Frame: From discharge home to 15 days of age ]

Original Secondary Outcome: Same as current

Information By: University of Alberta

Dates:
Date Received: August 12, 2008
Date Started: September 2008
Date Completion:
Last Updated: January 11, 2010
Last Verified: January 2010