Neonatal Hyperbilirubinemia
Conditions
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.
Interventions
DEVICEPhototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon
The baby will be treated with Bilicocoon for 24 hours. Decrease of total serum biliurubin will be evalueated hereafter.
DEVICEPhototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm
The baby will be treated with phototherapy from above for 24 hours. Decrease of total serum bilirubin will be evaluated hereafter.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Hemolysis due to isoimmunization * Very high or rapidly rising total serum bilirubin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Effect of phototherapy | Measurement of bilirubin before phototherapy and after 24 hours | Change in total serum bilirubin |
Outcome results
None listed