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Transcutaneous Bilirubinometers in the Community

NCT00735319 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2010-01-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Women and Children's Health Research Institute, Canada

    collaborator OTHER

  • Capital Health, Canada

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Thierry Lacaze, MD PhD FRCPC · University of Alberta

  • Philip Etches, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00735319 on ClinicalTrials.gov