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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00735319
Acronym
TcB RCT
Enrollment
10000
Registered
2008-08-14
Start date
2008-09-30
Completion date
2009-12-31
Last updated
2010-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaundice, Neonatal

Keywords

Neonatal Jaundice, Physiological Neonatal Jaundice, Neonatal Hyperbilirubinemia, Transcutaneous Bilirubinometer

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.

Interventions

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

Sponsors

Women and Children's Health Research Institute, Canada
CollaboratorOTHER
Capital Health, Canada
CollaboratorOTHER
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Hours to 2 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Number of serum bilirubin assessments, number of readmissions, length of admissions, highest level of bilirubin attained, and severity of treatment requiredFrom discharge home to 15 days of age

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026