Transcutaneous Bilirubinometry and Phototherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous bilirubinometry, Serum bilirubin.
- Who it may be relevant to
- Registry conditions: Neonatal Hyperbilirubinemia. Basic parameters: 0 Days — 2 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcutaneous Bilirubinometry in Neonatal Hyperbilirubinemia During and After Phototherapy: a Randomized Controlled Trial
Overview
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.
Interventions
- Diagnostic test Transcutaneous bilirubinometry
use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels - Diagnostic test Serum bilirubin
use of blood draws to measure serum bilirubin level
Primary outcome measures
- blood draws [Time frame: during hospitalisation with a maximum of 14 days]
Secondary outcome measures (2)
- phototherapy duration [Time frame: during hospitalisation with a maximum of 14 days]
- hospitalisation [Time frame: 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
Netherlands · 1 center
- Isala Klinieken — Zwolle
Identifiers
NCT: NCT04246229 · 202001