Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy of super-LED reverse phototherapy with the fluorescent reverse phototherapy in term and late preterm newborns.

Detailed Description
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This is a randomized controlled clinical trial with hospitalized infants in the Professor Fernando Figueira Medicine Institute(IMIP), who require phototherapy as an indication of the medical team. Following the sample calculation, 144 patients will be randomized according to gestational age (350/7-376/7 or 380/7-416/7 weeks) to receive super-LED reverse phototherapy or fluorescent reverse phototherapy with spectral irradiance of 8-12 microwatts/cm2/nm.The bilirubin will be determined by micromethod with bilirubinometer, after blood collection in heparinized capillary until bilirubin reaches level that indicates suspension of therapy.

Official Title
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Efficacy of Reverse Phototherapy With Super Light-emitting Diode(Super-led) in Term and Late Preterm Infants:Randomized and Controlled Clinical Trial

Conditions
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Neonatal Hyperbilirubinemia

Intervention / Treatment
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* Device: Phototherapy
* Device: Phototherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborns in the maternity Professor Fernando Figueira Medicine Institute(IMIP) Gestational age between 350/7 and 416/7 weeks Birth weight greater than 2200g Absence of congenital malformations indication of phototherapy after 48 hours of life Terms of consent signed by parent or guardian Exclusion Criteria: Total Bilirubin level indicative of phototherapy intensive or exchange transfusion RH incompatibility hemolytic disease Mother's refusal to continue to participate in the study Unavailability of the two types of phototherapy equipment for randomization Mother or newborn who received phenobarbital

Ages Eligible for Study
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Minimum Age: 35 Weeks
Maximum Age: 41 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BILITRON BED®<br>Super-LED reverse phototherapy | Device: Phototherapy<br>* super LED reverse phototherapy (17 bulbs arranged in 42 x 31 cm in blue base acrylic cot), with spectral irradiance of 8-12microwatts/cm2/nm; daily; until bilirubin reaches level that indicates suspension of therapy<br>* Other names: Super-LED reverse phototherapy;|
| Active Comparator: BILIBERÇO®<br>Fluorescent Reverse Phototherapy | Device: Phototherapy<br>* Fluorescent reverse phototherapy (7 white lights 5cm below the base of acrylic cot), with spectral irradiance of 8-12microwatts/cm2/nm; daily; until bilirubin reaches level that indicates suspension of therapy<br>* Other names: Fluorescent Light reverse phototherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilirubinemia | Bilirubin seric level decrease after 24 hours of phototherapy | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phototherapy Time | Number of hours needed to achieve a sufficiently low level of bilirubin that may allow suspension of phototherapy according to gestational age protocol. | 24 to 48 hours | 
| Adverse Effects | If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions | 24 to 48 hours | 
| Treatment Cost | number of lamps exchanges needed to maintain necessary irradiance | 24 to 48 hours | 
| Treatment Failure | In cases in which increase in irradiance(>30microwatts/cm2/nm) is needed to lower bilirubin levels. | 24 to 48 hours | 
| Rebound Hyperbilirubinemia | Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jaundice, Hyperbilirubinemia, Phototherapy and Super-LED Fluorescent lamps