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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Professor Fernando Figueira Integral Medicine Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier:
NCT01340339
First received: April 20, 2011
Last updated: April 21, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Neonatal Hyperbilirubinemia
Device: Phototherapy
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Professor Fernando Figueira Integral Medicine Institute:

Primary Outcome Measures:
  • Bilirubinemia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Bilirubin seric level decrease after 24 hours of phototherapy


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 144
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)
Arms Assigned Interventions
Experimental: BILITRON BED®
Super-LED reverse phototherapy
Device: 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
Device: 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Weeks to 41 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340339

Contacts
Contact: Danielle Cintra Bezerra Brandão +558191427761 daniellecbb@yahoo.com.br

Locations
Brazil
Danielle Cintra Bezerra Brandão Recruiting
Recife, Pernambuco, Brazil, 52030140
Contact: Fernanda M Almeida, PhD    55 11 98945750    fernandaalmeida@uol.com.br   
Principal Investigator: Danielle CB Brandao, postgraduate         
Sponsors and Collaborators
Professor Fernando Figueira Integral Medicine Institute
Investigators
Principal Investigator: Danielle Brandão Professor Fernando Figueira Medicine Institute
  More Information

No publications provided

Responsible Party: Danielle Cintra Bezerra Brandão, Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier: NCT01340339     History of Changes
Other Study ID Numbers: FernandoFigueiraIMI
Study First Received: April 20, 2011
Last Updated: April 21, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Professor Fernando Figueira Integral Medicine Institute:
Jaundice
Hyperbilirubinemia
Phototherapy and Super-LED Fluorescent lamps

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014