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Transcutaneous Bilirubinometry and Phototherapy

ConditionNeonatal Hyperbilirubinemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-2
SponsorPrincess Amalia Children's Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Neonates with indication for phototherapy for treatment of hyperbilirubinemia

Disqualifiers

skinlesions located on the sternum interfering with transcutaneous measurement

exchange transfusion

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous bilirubinometry

    Diagnostic test

    use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels

  • Serum bilirubin

    Diagnostic test

    use of blood draws to measure serum bilirubin level

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: transcutaneous bilirubinometryExperimental treatment 1 intervention
Group B: serum bilirubinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

blood draws

number of blood draws from the start of phototherapy for measurement of serum bilirubin

Time frame
during hospitalisation with a maximum of 14 days

Secondary outcomes

1

phototherapy duration

duration of phototherapy in hours

Time frame
during hospitalisation with a maximum of 14 days
2

hospitalisation

duration of hospitalisation in days

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Princess Amalia Children's Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: