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NCT04246229 | NOT YET RECRUITING | Neonatal Hyperbilirubinemia


Transcutaneous Bilirubinometry and Phototherapy
Sponsor:

Princess Amalia Children's Clinic

Information provided by (Responsible Party):

Fuel

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.

Condition or disease

Neonatal Hyperbilirubinemia

Intervention/treatment

Transcutaneous bilirubinometry

Serum bilirubin

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : DOUBLE
Primary Purpose : DIAGNOSTIC
Official Title : Transcutaneous Bilirubinometry in Neonatal Hyperbilirubinemia During and After Phototherapy: a Randomized Controlled Trial
Actual Study Start Date : 2026-01-01
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Days to 2 Weeks
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Neonates with indication for phototherapy for treatment of hyperbilirubinemia
Exclusion Criteria
  • * skinlesions located on the sternum interfering with transcutaneous measurement
  • * exchange transfusion

Transcutaneous Bilirubinometry and Phototherapy

Location Details

NCT04246229


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How to Participate

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Locations


Not yet recruiting

Netherlands, Overijssel

Isala Clinics

Zwolle, Overijssel, Netherlands, 8000 GK

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