Clinical Trial: Implementation of a Transcutaneous Bilirubinometer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Implementation of a Transcutaneous Bilirubinometer in Jaundiced Newborns: a Randomised Controlled Trial

Brief Summary: Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns. Assessment of the degree of jaundice is usually done visually,and if necessary serum bilirubin is investigated in a blood sample. The visual assessment is subjective and can alternatively be replaced by transcutaneous measurement.The transcutaneous bilirubinometer is a validated measurement-tool, which provides us with an estimated serum bilirubin-concentration. Little is known about the effect of the actual use of a bilirubinometer on the quality of care. Further evidence is needed to evaluate whether transcutaneous bilirubin measurements improve clinical outcome (use of blood tests, phototherapy and exchange transfusion), shorten length of stay and reduce costs. Therefore we aim to perform a Randomized controlled trial to evaluate the cost-effectiveness of implementing the use of a transcutaneous bilirubinometer in jaundiced neonates, a gestational age of 32 weeks. The assessment of jaundice by use of a transcutaneous bilirubinometer is compared to visual assessment of jaundice

Detailed Summary:

Rationale:

Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns. Severe hyperbilirubinemia can cause bilirubin encephalopathy (kernicterus). Assessment of the degree of jaundice is usually done visually,and if necessary serum bilirubin is investigated in a blood sample. The visual assessment is subjective and can alternatively be replaced by transcutaneous measurement.The transcutaneous bilirubinometer is a validated measurement-tool, which provides us with an estimated serum bilirubin-concentration. Little is known about the effect of the actual use of a bilirubinometer on the quality of care. Further evidence is needed to evaluate whether transcutaneous bilirubin measurements improve clinical outcome (use of blood tests, phototherapy and exchange transfusion), shorten length of stay and reduce costs.

Objective:

To evaluate the cost-effectiveness of implementing the use of a transcutaneous bilirubinometer in jaundiced neonates.

Study design:

Randomized controlled trial

Study population:

All jaundiced newborns beyond a gestational age of 32 weeks and younger than 8 days who are admitted at the maternity-ward or the neonatal-ward of our hospital.

Intervention:

Assessment of jaundice by use of a transcutaneous bilirubinometer.

Control:

Visual assessment of jaundice (current standard of care)

Main stu
Sponsor: Princess Amalia Children's Clinic

Current Primary Outcome: Number of blood tests for bilirubin measurement (Before the potential start of phototherapy). [ Time Frame: up to 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Phototherapy duration in hours [ Time Frame: up to 1 year ]
  • Number of serum bilirubin-values above the 'exchange transfusion limit' [ Time Frame: up to 1 year ]
  • Highest measured serum bilirubin-value [ Time Frame: up to 1 year ]
  • Cost-effectiveness [ Time Frame: up to 1 year ]
    Cost-effectiveness involves determination of serum bilirubin-values, use of the bilirubinometer and costs of the admission at the pediatric- or maternity ward.
  • Number of patients having kernicterus [ Time Frame: up to 1 year ]
    Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.


Original Secondary Outcome:

  • Phototherapy duration in hours [ Time Frame: up to 1 year ]
  • Number of serum bilirubin-values above the 'exchange transfusion limit' [ Time Frame: up to 1 year ]
  • Highest measured serum bilirubin-value [ Time Frame: up to 1 year ]
  • Cost-effectiveness [ Time Frame: up to 1 year ]
    Cost-effectiveness involves determination of serum bilirubin-values, use of the bilirubinometer and costs of the admission at the pediatric- or maternityward.
  • Number of patients having kernicterus [ Time Frame: up to 1 year ]
    Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.


Information By: Princess Amalia Children's Clinic

Dates:
Date Received: June 12, 2012
Date Started: October 2013
Date Completion:
Last Updated: July 18, 2016
Last Verified: July 2016