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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
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
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
Danielle Cintra Bezerra Brandão
Recife, Pernambuco, Brazil
RECRUITINGBilirubinemia
Bilirubin seric level decrease after 24 hours of phototherapy
Time frame: 24 hours
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.
Time frame: 24 to 48 hours
Adverse Effects
If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions
Time frame: 24 to 48 hours
Treatment Cost
number of lamps exchanges needed to maintain necessary irradiance
Time frame: 24 to 48 hours
Treatment Failure
In cases in which increase in irradiance(\>30microwatts/cm2/nm) is needed to lower bilirubin levels.
Time frame: 24 to 48 hours
Rebound Hyperbilirubinemia
Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart.
Time frame: 24 hours
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