Transcutaneous Bilirubinometers in the Community (TcB RCT)

January 11, 2010 updated by: University of Alberta

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada, T6L 5X8
        • Grey Nuns Community Hospital
      • Edmonton, Alberta, Canada, T5R 4H5
        • Misericordia Community Hospital
      • Edmonton, Alberta, Canada, T8N 6C4
        • Sturgeon Community Hospital
      • Fort Saskatchewan, Alberta, Canada, T8L 1R8
        • Fort Saskatchewan Health Centre
      • Stony Plain, Alberta, Canada, T7Z 2M7
        • Westview Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Minolta/Drager Air Shields JM-103 Jaundice Meter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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.
Time Frame: From discharge home to 15 days of age
From discharge home to 15 days of age

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From discharge home to 15 days of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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