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High Intensity Phototherapy: Double vs. Single

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ClinicalTrials.gov Identifier: NCT02805296
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
Aalborg University Hospital

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.

Condition or disease Intervention/treatment Phase
Hyperbilirubinemia Other: Light irradiance Not Applicable

Detailed Description:

Hyperbilirubinemia occurs in 60 - 80 % of newborns during the first days of life, among others because of immaturity of the enzyme uridin-glukuronosyl-transferase (UGT1A1) in the liver. In seldom cases with very high total serum bilirubin concentration (TsB), bilirubin can cross the blood-brain barrier and the deposition of unconjugated bilirubin in the central nervous system may cause acute bilirubin encephalopathy (ABE). This can progress to chronic bilirubin encephalopathy (CBE), a devastating condition, which unfortunately still occurs, even in industrialised countries.

Hyperbilirubinemia gets severe for 2 - 6 % of infants born at term or late preterm, which means, they need treatment to prevent ABE and the treatment of choice is phototherapy due to its efficacy and safety. Hereby bilirubin in the skin and plasma is converted to photobilirubins; they are water-soluble and can be excreted through the liver without conjugation. They are presumably non-toxic. In most departments, single phototherapy is first choice. To avoid the above-mentioned damaging condition, it is very important to optimize phototherapy.

Former fluorescent tubes were used as light source, but now light emission diodes (LED) are used.

This study investigates whether double phototherapy reduces total serum bilirubin faster than single light during intensive phototherapy, using LED, and whether there is an upper limit for the efficacy of phototherapy.

It is a prospective, randomised controlled study. The infants will be randomized to either 1: Conventional phototherapy with blue LED light from above and a distance from light source to mattress of 30 cm, giving a light irradiance of 66 µW/cm2/nm or 2: Conventional phototherapy combined with a light blanket (Bilisoft) with a light irradiance by the skin of 39 µW/cm2/nm. TsB will be measured at start and after 12 - and 24 h of treatment. Based on the calculation of strength 72 infants will be needed in this study. As statistical methods t-tests will be used and multiple linear regression models will be used to adjust for confounding.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Phototherapy, Double vs. Single, in Treatment of Neonatal Hyperbilirubinemia Using LED
Study Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Arm Intervention/treatment
Active Comparator: Double light

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
Comparison of double vs. single phototherapy

Active Comparator: Single light
High-intensity phototherapy with blue LED light from above. Intervention: Light irradiance: 66 µW/cm2/nm
Other: Light irradiance
Comparison of double vs. single phototherapy




Primary Outcome Measures :
  1. Decrease in total serum bilirubin after 12- and 24 hours of phototherapy, measured in percent. [ Time Frame: 12 and 24 Hours og phototherapy ]
    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.


Secondary Outcome Measures :
  1. Whether total serum bilirubin continues to decrease measured in percent after 24 hours of high-intensity phototherapy [ Time Frame: 24 Hours of phototherapy ]
    To figure out, whether there is an upper limit for the efficacy of phototherapy, i.e. a plateau above which total serum bilirubin does not decrease any further.



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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805296


Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Principal Investigator: Mette L Roed, MD Aalborg University Hospital

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Responsible Party: Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT02805296     History of Changes
Other Study ID Numbers: N-20140010
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hyperbilirubinemia
Pathologic Processes