Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants
Efficacy of Reverse Phototherapy With Super Light-emitting Diode(Super-led) in Term and Late Preterm Infants:Randomized and Controlled Clinical Trial
1 other identifier
interventional
144
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 20, 2011
CompletedFirst Posted
Study publicly available on registry
April 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedApril 22, 2011
April 1, 2011
1 year
April 20, 2011
April 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bilirubinemia
Bilirubin seric level decrease after 24 hours of phototherapy
24 hours
Secondary Outcomes (5)
Phototherapy Time
24 to 48 hours
Adverse Effects
24 to 48 hours
Treatment Cost
24 to 48 hours
Treatment Failure
24 to 48 hours
Rebound Hyperbilirubinemia
24 hours
Study Arms (2)
BILITRON BED®
EXPERIMENTALSuper-LED reverse phototherapy
BILIBERÇO®
ACTIVE COMPARATORFluorescent Reverse Phototherapy
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Danielle Cintra Bezerra Brandão
Recife, Pernambuco, 52030140, Brazil
Related Publications (1)
Brandao DC, Draque CM, Sanudo A, de Gusmao Filho FA, de Almeida MF. LED versus daylight phototherapy at low irradiance in newborns >/=35 weeks of gestation: randomized controlled trial. J Matern Fetal Neonatal Med. 2015;28(14):1725-30. doi: 10.3109/14767058.2014.966678. Epub 2014 Nov 5.
PMID: 25234100DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Brandão
Professor Fernando Figueira Medicine Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 20, 2011
First Posted
April 22, 2011
Study Start
October 1, 2010
Primary Completion
October 1, 2011
Study Completion
January 1, 2012
Last Updated
April 22, 2011
Record last verified: 2011-04