NCT00735319

Transcutaneous Bilirubinometers in the Community

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,000 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 24 Hours – 2 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Jaundice, Neonatal

Interventions

Type	Name	Description
DEVICE	Transcutaneous Bilirubinometer	For all eligible babies living in the 7 intervention community health centers, a Transcutaneous Bilirubinometer will be routinely used by all community nurses in conjunction with an algorithm that will guide the nursing management of the neonates based on the values obtained

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-08-14
• Last updated: 2010-01-12

Locations

6 sites across 1 country: Canada