Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants
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|ClinicalTrials.gov Identifier: NCT01340339|
Recruitment Status : Unknown
Verified April 2011 by Professor Fernando Figueira Integral Medicine Institute.
Recruitment status was: Recruiting
First Posted : April 22, 2011
Last Update Posted : April 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Hyperbilirubinemia||Device: Phototherapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Reverse Phototherapy With Super Light-emitting Diode(Super-led) in Term and Late Preterm Infants:Randomized and Controlled Clinical Trial|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||January 2012|
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
- Bilirubinemia [ Time Frame: 24 hours ]Bilirubin seric level decrease after 24 hours of phototherapy
- Phototherapy Time [ Time Frame: 24 to 48 hours ]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 ]If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions
- Treatment Cost [ Time Frame: 24 to 48 hours ]number of lamps exchanges needed to maintain necessary irradiance
- Treatment Failure [ Time Frame: 24 to 48 hours ]In cases in which increase in irradiance(>30microwatts/cm2/nm) is needed to lower bilirubin levels.
- Rebound Hyperbilirubinemia [ Time Frame: 24 hours ]Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart.
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): NCT01340339
|Contact: Danielle Cintra Bezerra Brandãoemail@example.com|
|Danielle Cintra Bezerra Brandão||Recruiting|
|Recife, Pernambuco, Brazil, 52030140|
|Contact: Fernanda M Almeida, PhD 55 11 98945750 firstname.lastname@example.org|
|Principal Investigator: Danielle CB Brandao, postgraduate|
|Principal Investigator:||Danielle Brandão||Professor Fernando Figueira Medicine Institute|