Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Reverse Phototherapy With Super Light-emitting Diode(Super-led) in Term and Late Preterm Infants:Randomized and Controlled Clinical Trial|
- Bilirubinemia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Bilirubin seric level decrease after 24 hours of phototherapy
- Phototherapy Time [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]Number of hours needed to achieve a sufficiently low level of bilirubin that may allow suspension of phototherapy according to gestational age protocol.
- Adverse Effects [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions
- Treatment Cost [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]number of lamps exchanges needed to maintain necessary irradiance
- Treatment Failure [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]In cases in which increase in irradiance(>30microwatts/cm2/nm) is needed to lower bilirubin levels.
- Rebound Hyperbilirubinemia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: BILITRON BED®
Super-LED reverse phototherapy
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
Other Name: Super-LED reverse phototherapy
Active Comparator: BILIBERÇO®
Fluorescent Reverse Phototherapy
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
Other Name: Fluorescent Light reverse phototherapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340339
|Contact: Danielle Cintra Bezerra Brandãofirstname.lastname@example.org|
|Danielle Cintra Bezerra Brandão||Recruiting|
|Recife, Pernambuco, Brazil, 52030140|
|Contact: Fernanda M Almeida, PhD 55 11 98945750 email@example.com|
|Principal Investigator: Danielle CB Brandao, postgraduate|
|Principal Investigator:||Danielle Brandão||Professor Fernando Figueira Medicine Institute|