Transcutaneous Bilirubinometers in the Community

NCT00735319 | Completed

• 1 other identifier: 7034
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 6

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

Keywords

Neonatal Jaundice; Physiological Neonatal Jaundice; Neonatal Hyperbilirubinemia; Transcutaneous Bilirubinometer

Outcome Measures

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.

  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

  From discharge home to 15 days of age

Study Arms (2)

A

NO INTERVENTION

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.

B

EXPERIMENTAL

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

Interventions

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

Also known as: Minolta/Drager Air Shields JM-103 Jaundice Meter

B

Eligibility Criteria

• Age: 24 Hours - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Women and Children's Health Research Institute, Canada: collaborator
• Capital Health, Canada: collaborator

Study Sites (6)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Misericordia Community Hospital

Edmonton, Alberta, T5R 4H5, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

Sturgeon Community Hospital

Edmonton, Alberta, T8N 6C4, Canada

Location

Fort Saskatchewan Health Centre

Ft Saskatchewan, Alberta, T8L 1R8, Canada

Location

WestView Health Centre

Stony Plain, Alberta, T7Z 2M7, Canada

Location

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thierry Lacaze, MD PhD FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Philip Etches, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 12, 2010

Record last verified: 2010-01

Locations

CA (6)