Transcutaneous Bilirubinometers in the Community (TcB RCT)

This study has been completed.
Sponsor:
Collaborators:
Women and Children's Health Research Institute, Canada
Capital Health, Canada
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00735319
First received: August 12, 2008
Last updated: January 11, 2010
Last verified: January 2010

August 12, 2008
January 11, 2010
September 2008
December 2009   (final data collection date for primary outcome 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. [ Time Frame: From discharge home to 15 days of age ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00735319 on ClinicalTrials.gov Archive Site
Number of serum bilirubin assessments, number of readmissions, length of admissions, highest level of bilirubin attained, and severity of treatment required [ Time Frame: From discharge home to 15 days of age ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Transcutaneous Bilirubinometers in the Community
Transcutaneous Bilirubinometers in the Community and the Reduction of Morbidity Associated to Jaundice: A Clustered Randomized Controlled Trial.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Jaundice, Neonatal
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
Other Name: Minolta/Drager Air Shields JM-103 Jaundice Meter
  • No Intervention: A
    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.
  • Experimental: B
    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.
    Intervention: Device: Transcutaneous Bilirubinometer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10000
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
up to 2 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00735319
7034
No
Dr. Thierry Lacaze, University of Alberta
University of Alberta
  • Women and Children's Health Research Institute, Canada
  • Capital Health, Canada
Principal Investigator: Thierry Lacaze, MD PhD FRCPC University of Alberta
Principal Investigator: Philip Etches, MD University of Alberta
University of Alberta
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP