Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

University of Aarhus

Status: Unknown

Conditions: Neonatal Hyperbilirubinemia

Treatments: Device: Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm; Device: Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon

Study type: Interventional

Funder types: Other

Identifiers

NCT04585828

71051

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 1 to 14 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Bili Cocoon

Experimental group

Description:

The infants will be treated with phototherapy using a double sided fiber optic pad called Bili Cocoon with an irradiance of 30 uW/cm2/nm from both sides.

Treatment:

Device: Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon

Conventional blue light

Active Comparator group

Description:

The infants will be treated with blue light from above at 30 Uw/cm2/nm which is the standard treatment.

Treatment:

Device: Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm