Transcutaneous Bilirubinometers in the Community
- Conditions
- Jaundice, Neonatal
- Interventions
- Device: Transcutaneous Bilirubinometer
- Registration Number
- NCT00735319
- Lead Sponsor
- University of Alberta
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10000
- All near term (35 and 36 weeks gestational age) and term (37 to 41 weeks) babies living in Alberta Capital Health (CH) region
- Born at any Capital Health or Caritas delivery facility(Royal Alexandra Hospital, Grey Nuns Community Hospital, Misericordia Community Hospital, Sturgeon Community Hospital, Fort Saskatchewan Health Centre, and WestView Health Centre)
- Discharged home from the nursery within 96 hours of life
- Babies who do not live in CH region
- Babies born at less than 35 weeks gestational age
- Babies initially admitted to a Special Care Nursery (SCN) or a Neonatal Intensive Care unit (NICU) for more than 72 hours
- Babies born to opting-out mothers will also be excluded
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B 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.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.
- Primary Outcome Measures
Name Time Method Percentage of neonates with at least one serum bilirubin measurement over the 95th percentile, i.e. 350 micromoles/L after 48 hours of age. From discharge home to 15 days of age
- Secondary Outcome Measures
Name Time Method Number of serum bilirubin assessments, number of readmissions, length of admissions, highest level of bilirubin attained, and severity of treatment required From discharge home to 15 days of age
Trial Locations
- Locations (6)
Sturgeon Community Hospital
🇨🇦Edmonton, Alberta, Canada
WestView Health Centre
🇨🇦Stony Plain, Alberta, Canada
Fort Saskatchewan Health Centre
🇨🇦Fort Saskatchewan, Alberta, Canada
Grey Nuns Community Hospital
🇨🇦Edmonton, Alberta, Canada
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Misericordia Community Hospital
🇨🇦Edmonton, Alberta, Canada