High Intensity Phototherapy: Double vs. Single

NCT02805296 | Completed

• 1 other identifier: N-20140010
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intensive phototherapy in form of double light is used worldwide in the treatment of severe neonatal hyperbilirubinemia. It has been debated if there is an upper limit on the efficiency of phototherapy. This study investigates whether double phototherapy reduces total serum bilirubin faster than single light during intensive phototherapy, using light emitting diodes, and whether there is an upper limit for the efficacy of phototherapy.

Conditions

Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• Decrease in total serum bilirubin after 12- and 24 hours of phototherapy, measured in percent.

  Total serum bilirubin will be measured at start of phototherapy, after 12 - and after 24 hours of phototherapy for both Groups. Primary outcome measure is, whether double phototherapy decreases total serum bilirubin faster than single phototherapy after 12- and/or after 24 hours of phototherapy.

  12 and 24 Hours og phototherapy

Secondary Outcomes (1)

• Whether total serum bilirubin continues to decrease measured in percent after 24 hours of high-intensity phototherapy

  24 Hours of phototherapy

Study Arms (2)

Double light

ACTIVE COMPARATOR

High-intensity phototherapy with blue LED light from above combined with a fiber optic, blue LED blanket from below. Intervention: Light irradiance: 66 µW/cm2/nm + 39 µW/cm2/nm

Other: Light irradiance

Single light

ACTIVE COMPARATOR

High-intensity phototherapy with blue LED light from above. Intervention: Light irradiance: 66 µW/cm2/nm

Other: Light irradiance

Interventions

Light irradiance OTHER

Comparison of double vs. single phototherapy

Double light; Single light

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Otherwise healthy newborn infants with hyperbilirubinemia without signs of hemolytic disease
• gestational age ≥33 weeks
• birth weight ≥1800 g
• The infants should be treatable in a cradle

You may not qualify if:

• Infants fulfilling the indications for exchange transfusion or double phototherapy due to a very high initial or rapidly increasing TsB will not be enrolled.

Sponsors & Collaborators

• Aalborg University Hospital: lead

MeSH Terms

Conditions

Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mette L Roed, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 20, 2016
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 20, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share