Transcutaneous Bilirubinometry and Phototherapy
- Conditions
- Neonatal Hyperbilirubinemia
- Registration Number
- NCT04246229
- Lead Sponsor
- Princess Amalia Children's Clinic
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 130
- Neonates with indication for phototherapy for treatment of hyperbilirubinemia
- skinlesions located on the sternum interfering with transcutaneous measurement
- exchange transfusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method blood draws during hospitalisation with a maximum of 14 days number of blood draws from the start of phototherapy for measurement of serum bilirubin
- Secondary Outcome Measures
Name Time Method hospitalisation 3 months duration of hospitalisation in days
phototherapy duration during hospitalisation with a maximum of 14 days duration of phototherapy in hours
Trial Locations
- Locations (1)
Isala Klinieken
🇳🇱Zwolle, Overijssel, Netherlands
Isala Klinieken🇳🇱Zwolle, Overijssel, Netherlands