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OpenTrials
Completed

NCT Number: NCT00735319

Transcutaneous Bilirubinometers in the Community

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.

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Key information

Age range

24 hour–2 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grey Nuns Community Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Bilirubinometer

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

Other names: Minolta/Drager Air Shields JM-103 Jaundice Meter

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Capital Health, Canada
  • Women and Children's Health Research Institute, Canada

Registry information

Official study title

Transcutaneous Bilirubinometers in the Community and the Reduction of Morbidity Associated to Jaundice: A Clustered Randomized Controlled Trial.

Acronym: TcB RCT

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 14, 2008
Registry last updated
Jan 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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