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

Primary Purpose

Neonatal Hyperbilirubinemia

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Phototherapy
Phototherapy
Sponsored by
Professor Fernando Figueira Integral Medicine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Hyperbilirubinemia focused on measuring Jaundice, Hyperbilirubinemia, Phototherapy and Super-LED Fluorescent lamps

Eligibility Criteria

35 Weeks - 41 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Danielle Cintra Bezerra BrandãoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BILITRON BED®

BILIBERÇO®

Arm Description

Super-LED reverse phototherapy

Fluorescent Reverse Phototherapy

Outcomes

Primary Outcome Measures

Bilirubinemia
Bilirubin seric level decrease after 24 hours of phototherapy

Secondary Outcome Measures

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.
Adverse Effects
If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions
Treatment Cost
number of lamps exchanges needed to maintain necessary irradiance
Treatment Failure
In cases in which increase in irradiance(>30microwatts/cm2/nm) is needed to lower bilirubin levels.
Rebound Hyperbilirubinemia
Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart.

Full Information

First Posted
April 20, 2011
Last Updated
April 21, 2011
Sponsor
Professor Fernando Figueira Integral Medicine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01340339
Brief Title
Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Professor Fernando Figueira Integral Medicine Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hyperbilirubinemia
Keywords
Jaundice, Hyperbilirubinemia, Phototherapy and Super-LED Fluorescent lamps

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BILITRON BED®
Arm Type
Experimental
Arm Description
Super-LED reverse phototherapy
Arm Title
BILIBERÇO®
Arm Type
Active Comparator
Arm Description
Fluorescent Reverse Phototherapy
Intervention Type
Device
Intervention Name(s)
Phototherapy
Other Intervention Name(s)
Fluorescent Light reverse phototherapy
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Phototherapy
Other Intervention Name(s)
Super-LED reverse phototherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Bilirubinemia
Description
Bilirubin seric level decrease after 24 hours of phototherapy
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Phototherapy Time
Description
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
Title
Adverse Effects
Description
If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions
Time Frame
24 to 48 hours
Title
Treatment Cost
Description
number of lamps exchanges needed to maintain necessary irradiance
Time Frame
24 to 48 hours
Title
Treatment Failure
Description
In cases in which increase in irradiance(>30microwatts/cm2/nm) is needed to lower bilirubin levels.
Time Frame
24 to 48 hours
Title
Rebound Hyperbilirubinemia
Description
Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
41 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Cintra Bezerra Brandão
Phone
+558191427761
Email
daniellecbb@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Brandão
Organizational Affiliation
Professor Fernando Figueira Medicine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danielle Cintra Bezerra Brandão
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
52030140
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda M Almeida, PhD
Phone
55 11 98945750
Email
fernandaalmeida@uol.com.br
First Name & Middle Initial & Last Name & Degree
Danielle CB Brandao, postgraduate

12. IPD Sharing Statement

Citations:
PubMed Identifier
25234100
Citation
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.
Results Reference
derived

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

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