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
  Purpose

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
Jaundice, Neonatal
Device: Transcutaneous Bilirubinometer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Transcutaneous Bilirubinometers in the Community and the Reduction of Morbidity Associated to Jaundice: A Clustered Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10000
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735319

Locations
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
Misericordia Community Hospital
Edmonton, Alberta, Canada, T5R 4H5
Sturgeon Community Hospital
Edmonton, Alberta, Canada, T8N 6C4
Fort Saskatchewan Health Centre
Fort Saskatchewan, Alberta, Canada, T8L 1R8
WestView Health Centre
Stony Plain, Alberta, Canada, T7Z 2M7
Sponsors and Collaborators
University of Alberta
Women and Children's Health Research Institute, Canada
Capital Health, Canada
Investigators
Principal Investigator: Thierry Lacaze, MD PhD FRCPC University of Alberta
Principal Investigator: Philip Etches, MD University of Alberta
  More Information

No publications provided

Responsible Party: Dr. Thierry Lacaze, University of Alberta
ClinicalTrials.gov Identifier: NCT00735319     History of Changes
Other Study ID Numbers: 7034
Study First Received: August 12, 2008
Last Updated: January 11, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Neonatal Jaundice
Physiological Neonatal Jaundice
Neonatal Hyperbilirubinemia
Transcutaneous Bilirubinometer

Additional relevant MeSH terms:
Jaundice
Jaundice, Neonatal
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 17, 2014