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

April 21, 2011 updated by: Professor Fernando Figueira Integral Medicine Institute

Efficacy of Reverse Phototherapy With Super Light-emitting Diode(Super-led) in Term and Late Preterm Infants:Randomized and Controlled Clinical Trial

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 52030140
        • Recruiting
        • Danielle Cintra Bezerra Brandão
        • Contact:
        • Principal Investigator:
          • Danielle CB Brandao, postgraduate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BILITRON BED®
Super-LED 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 Names:
  • Fluorescent Light 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 Names:
  • 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 Names:
  • Fluorescent Light 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 Names:
  • Super-LED reverse phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilirubinemia
Time Frame: 24 hours
Bilirubin seric level decrease after 24 hours of phototherapy
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 to 48 hours
Adverse Effects
Time Frame: 24 to 48 hours
If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions
24 to 48 hours
Treatment Cost
Time Frame: 24 to 48 hours
number of lamps exchanges needed to maintain necessary irradiance
24 to 48 hours
Treatment Failure
Time Frame: 24 to 48 hours
In cases in which increase in irradiance(>30microwatts/cm2/nm) is needed to lower bilirubin levels.
24 to 48 hours
Rebound Hyperbilirubinemia
Time Frame: 24 hours
Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Fernando Figueira Integral Medicine Institute

Investigators

  • Principal Investigator: Danielle Brandão, Professor Fernando Figueira Medicine Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

April 22, 2011

Last Update Submitted That Met QC Criteria

April 21, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FernandoFigueiraIMI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neonatal Hyperbilirubinemia

Clinical Trials on Phototherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe