Transcutaneous Bilirubinometers in the Community

NCT ID: NCT00735319

Last Updated: 2010-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Jaundice, Neonatal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Transcutaneous Bilirubinometer

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Minolta/Drager Air Shields JM-103 Jaundice Meter

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

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 2 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women and Children's Health Research Institute, Canada

OTHER

Sponsor Role: collaborator

Capital Health, Canada

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

University of Alberta

Principal Investigators

Thierry Lacaze, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Philip Etches, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Misericordia Community Hospital

Edmonton, Alberta, Canada

Grey Nuns Community Hospital

Edmonton, Alberta, Canada

Sturgeon Community Hospital

Edmonton, Alberta, Canada

Fort Saskatchewan Health Centre

Ft Saskatchewan, Alberta, Canada

WestView Health Centre

Stony Plain, Alberta, Canada

Countries

Canada

Other Identifiers

7034

Identifier Type: -

Identifier Source: org_study_id