Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy
- Conditions
- Neonatal Hyperbilirubinemia
- Registration Number
- NCT04585828
- Lead Sponsor
- University of Aarhus
- Brief Summary
A randomized study of phototherapy for neonatal hyperbilirubinemia. The intervention group is treated with a double pad fiber optic device and the control group with conventional blue ligt phototherapy from above. Both treatments are well known and used. The primary outcome is to explore the parents experience with the two different treatment modalities by questionnaires.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Neonatal icterus and total serum bilirubin above threshold for phototherapy.
- Gestational age ≥ 33 weeks
- Birth weight ≥ 1800 gr
- Postnatal age > 24 hours and < 2 weeks
- Hemolysis due to isoimmunization
- Very high or rapidly rising total serum bilirubin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Questionnaire on the parents experience with the phototherapy treatment Day 1 of phototherapy Parents experience of phototherapy.
Questions at time of beginning phototherapy (1):
"What did you feel at the time your baby started treatment with phototherapy?"
Questions after phototherapy (2):
"What did you experience with your baby during the time of phototherapy?"
The parents answer on a scale from "I agree, I partly agree, N/A, I partly disagreee, I disagree"
Examples of questions:
"I felt well informed about the indication and use of phototherapy" (Answer: I agree, partly agree, disagreee etc,)
"I was difficult to breastfeed while my baby was on phototherapy" (Answer as above described)
- Secondary Outcome Measures
Name Time Method Effect of phototherapy Measurement of bilirubin before phototherapy and after 24 hours Change in total serum bilirubin