Neonatal Hyperbilirubinemia
Conditions
Keywords
transcutaneous bilirubinometry, phototherapy, neonatal icterus, neonatal jaundice, newborn
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.
Interventions
DIAGNOSTIC_TESTTranscutaneous bilirubinometry
use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels
DIAGNOSTIC_TESTSerum bilirubin
use of blood draws to measure serum bilirubin level
Sponsors
Princess Amalia Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to 2 Weeks
Healthy volunteers
No
Inclusion criteria
* Neonates with indication for phototherapy for treatment of hyperbilirubinemia
Exclusion criteria
* skinlesions located on the sternum interfering with transcutaneous measurement * exchange transfusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| phototherapy duration | during hospitalisation with a maximum of 14 days | duration of phototherapy in hours |
| hospitalisation | 3 months | duration of hospitalisation in days |
Countries
Netherlands
Contacts
Primary ContactJolita Bekhof, MD, PhD
Outcome results
None listed