Transcutaneous Bilirubinometry and Phototherapy

Study Overview
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Brief Summary
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A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia. Main outcome measurement is the number of blooddraws for measurement of bilirubin. Secondary outcome measurements are duration of phototherapy and hospitalisation.

Detailed Description
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A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia. Main outcome measurement is the number of blooddraws for measurement of bilirubin. Secondary outcome measurements are duration of phototherapy and hospitalisation.

Official Title
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Transcutaneous Bilirubinometry in Neonatal Hyperbilirubinemia During and After Phototherapy: a Randomized Controlled Trial

Conditions
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Neonatal Hyperbilirubinemia

Intervention / Treatment
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* Diagnostic Test: Transcutaneous bilirubinometry
* Diagnostic Test: Serum bilirubin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates with indication for phototherapy for treatment of hyperbilirubinemia Exclusion Criteria: skinlesions located on the sternum interfering with transcutaneous measurement exchange transfusion

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 2 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcutaneous bilirubinometry<br>in this arm the bilirubin level to monitor the effect of phototherapy will be measured through transcutaneous mbiirubinometry | Diagnostic Test: Transcutaneous bilirubinometry<br>* use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels<br>|
| Active Comparator: serum bilirubin<br>In this arm the bilirubin level to monitor the effect of phototherapy wil be measured through measurements of serum bilirubin obtained through blood draws | Diagnostic Test: Serum bilirubin<br>* use of blood draws to measure serum bilirubin level<br>* Other names: blood draw;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood draws | number of blood draws from the start of phototherapy for measurement of serum bilirubin | during hospitalisation with a maximum of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| phototherapy duration | duration of phototherapy in hours | during hospitalisation with a maximum of 14 days | 
| hospitalisation | duration of hospitalisation in days | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcutaneous bilirubinometry, phototherapy, neonatal icterus, neonatal jaundice, newborn