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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transcutaneous bilirubinometry | Experimental | in this arm the bilirubin level to monitor the effect of phototherapy will be measured through transcutaneous mbiirubinometry |
|
| serum bilirubin | Active Comparator | In this arm the bilirubin level to monitor the effect of phototherapy wil be measured through measurements of serum bilirubin obtained through blood draws |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous bilirubinometry | Diagnostic Test | use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jolita Bekhof, MD, PhD | Contact | +31384245050 | j.bekhof@isala.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jolita Bekhof, MD,PhD | 1971 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala Klinieken | Zwolle | Overijssel | 8000 GK | Netherlands |
After publishing the results the individual participant data will be anonimously available upon request
after publication in a peer reviewed journal during 3 years
relevant research question
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| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Serum bilirubin | Diagnostic Test | use of blood draws to measure serum bilirubin level |
|
|
| 3 months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |