Implementation of a Transcutaneous Bilirubinometer among Newborns: A Randomized Controlled Trial

Conditions: hyperbilirubinemia
neonatal jaundice
10028920

Registration Number: NL-OMON37522

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 550

Inclusion Criteria

All newborns at the pediatric- and maternity-ward with visible jaundice.
Gestational age of 32 weeks or more.
Older than 24 hours.
younger than 8 days.

Exclusion Criteria

Neonatal jaundice within 24 hours or after 8 days
Hemolysis present based on maternal history (for example irregular erythrocyte antibodies)
Bilirubin encephalopathy
Newborns during/after phototherapy
Large congenital anomaly at forehead/sternum
Serum bilirubin-value is already known before admission to the pediatric ward;those newborns are to be admitted because the serum bilirubin-level has reached the phototherapy or exchange transfusion limit.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primairy outcome variable: the number of blood tests for bilirubin measurement<br /><br>(Before the potential start of phototherapy).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome: Phototherapy duration in hours, Number of serum<br /><br>bilirubin-values above the 'exchange transfusion limit', Highest measured serum<br /><br>bilirubin-value, Cost-effectiveness (blood test, use bilirubinometer, costs<br /><br>admittance), Number of patients having kernicterus.</p><br>