Clinical trial NCT00735319: Transcutaneous Bilirubinometers in the Community
Official title: Transcutaneous Bilirubinometers in the Community and the Reduction of Morbidity Associated to Jaundice: A Clustered Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice, Neonatal
Keywords: Neonatal Jaundice
Physiological Neonatal Jaundice
Neonatal Hyperbilirubinemia
Transcutaneous Bilirubinometer
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Women and Children's Health Research Institute, Canada
name: Capital Health, Canada
First posted: 2008-08-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 24
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of neonates with at least one serum bilirubin measurement over the 95th percentile, i.e. 350 micromoles/L after 48 hours of age.
timeFrame: From discharge home to 15 days of age
Secondary outcomes:
measure: Number of serum bilirubin assessments, number of readmissions, length of admissions, highest level of bilirubin attained, and severity of treatment required
timeFrame: From discharge home to 15 days of age
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Misericordia Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Sturgeon Community Hospital
state: Alberta
city: Fort Saskatchewan
country: Canada
facility: Fort Saskatchewan Health Centre
state: Alberta
city: Stony Plain
country: Canada
facility: WestView Health Centre
state: Alberta
Study officials:
affiliation: University of Alberta
name: Thierry Lacaze, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Philip Etches, MD
role: PRINCIPAL_INVESTIGATOR
References: