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Sponsors and Collaborators: |
University of Alberta Women and Children's Health Research Institute Capital Health, Canada |
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Information provided by: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT00735319 |
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.
Condition | Intervention |
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Jaundice, Neonatal |
Device: Transcutaneous Bilirubinometer |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Transcutaneous Bilirubinometers in the Community and the Reduction of Morbidity Associated to Jaundice: A Clustered Randomized Controlled Trial. |
Estimated Enrollment: | 10000 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: No Intervention
In the 7 control Capital Health community health centers, babies will be followed up according to the current policy. Bilirubin determinations will be performed at the discretion of the visiting nurse if the infant is inappropriately jaundiced or at the request of the physician if risk factors are present. Transcutaneous Bilirubinometers will not be available in each of these 7 centers for all the duration of the study.
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B: Experimental
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.Depending on the level of bilirubin obtained and whether risk factors (gestational age < 38 weeks, blood group incompatibility with DAT positive) are present or not, a different management plan will apply. The algorithm is based on curves established by Bhutani et al to predict the risk of significant hyperbilirubinemia based on predischarge bilirubin measurements.
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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
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Ages Eligible for Study: | up to 2 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thierry Lacaze, MD PhD FRCPC | (780) 407-1178 | Thierry.Lacaze@capitalhealth.ca |
Contact: Lacey Benoit | (780) 407-8085 | lacey.benoit@ualberta.ca |
Canada, Alberta | |
Royal Alexandra Hospital | Recruiting |
Edmonton, Alberta, Canada, T5H 3V9 | |
Grey Nuns Community Hospital | Recruiting |
Edmonton, Alberta, Canada, T6L 5X8 | |
Misericordia Community Hospital | Recruiting |
Edmonton, Alberta, Canada, T5R 4H5 | |
WestView Health Centre | Recruiting |
Stony Plain, Alberta, Canada, T7Z 2M7 | |
Fort Saskatchewan Health Centre | Recruiting |
Fort Saskatchewan, Alberta, Canada, T8L 1R8 | |
Sturgeon Community Hospital | Recruiting |
Edmonton, Alberta, Canada, T8N 6C4 |
Principal Investigator: | Thierry Lacaze, MD PhD FRCPC | University of Alberta |
Principal Investigator: | Philip Etches, MD | University of Alberta |
Responsible Party: | University of Alberta ( Dr. Thierry Lacaze ) |
Study ID Numbers: | 7034 |
Study First Received: | August 12, 2008 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00735319 |
Health Authority: | Canada: Health Canada |
Neonatal Jaundice Physiological Neonatal Jaundice Neonatal Hyperbilirubinemia Transcutaneous Bilirubinometer |
Signs and Symptoms Hyperbilirubinemia Infant, Newborn, Diseases |
Jaundice, Neonatal Jaundice Hyperbilirubinemia, Neonatal |
Skin Manifestations Pathologic Processes |