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Transcutaneous Bilirubinometers in the Community (TcB RCT)

Primary Purpose

Jaundice, Neonatal

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcutaneous Bilirubinometer
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Jaundice, Neonatal focused on measuring Neonatal Jaundice, Physiological Neonatal Jaundice, Neonatal Hyperbilirubinemia, Transcutaneous Bilirubinometer

Eligibility Criteria

24 Hours - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Alexandra Hospital
  • Misericordia Community Hospital
  • Grey Nuns Community Hospital
  • Sturgeon Community Hospital
  • Fort Saskatchewan Health Centre
  • WestView Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

A

B

Arm Description

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.

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.

Outcomes

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.

Secondary Outcome Measures

Number of serum bilirubin assessments, number of readmissions, length of admissions, highest level of bilirubin attained, and severity of treatment required

Full Information

First Posted
August 12, 2008
Last Updated
January 11, 2010
Sponsor
University of Alberta
Collaborators
Women and Children's Health Research Institute, Canada, Capital Health, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00735319
Brief Title
Transcutaneous Bilirubinometers in the Community
Acronym
TcB RCT
Official Title
Transcutaneous Bilirubinometers in the Community and the Reduction of Morbidity Associated to Jaundice: A Clustered Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta
Collaborators
Women and Children's Health Research Institute, Canada, Capital Health, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Neonatal
Keywords
Neonatal Jaundice, Physiological Neonatal Jaundice, Neonatal Hyperbilirubinemia, Transcutaneous Bilirubinometer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
No Intervention
Arm Description
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.
Arm Title
B
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Transcutaneous Bilirubinometer
Other Intervention Name(s)
Minolta/Drager Air Shields JM-103 Jaundice Meter
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Lacaze, MD PhD FRCPC
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip Etches, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Misericordia Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 4H5
Country
Canada
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
Sturgeon Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T8N 6C4
Country
Canada
Facility Name
Fort Saskatchewan Health Centre
City
Fort Saskatchewan
State/Province
Alberta
ZIP/Postal Code
T8L 1R8
Country
Canada
Facility Name
WestView Health Centre
City
Stony Plain
State/Province
Alberta
ZIP/Postal Code
T7Z 2M7
Country
Canada

12. IPD Sharing Statement

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Transcutaneous Bilirubinometers in the Community

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