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

NCT ID: NCT01340339

Last Updated: 2011-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Neonatal Hyperbilirubinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BILITRON BED®

Super-LED reverse phototherapy

Group Type EXPERIMENTAL

Phototherapy

Intervention Type DEVICE

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

BILIBERÇO®

Fluorescent Reverse Phototherapy

Group Type ACTIVE_COMPARATOR

Phototherapy

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Fluorescent Light reverse phototherapy Super-LED reverse phototherapy

Eligibility Criteria

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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
Minimum Eligible Age

35 Weeks

Maximum Eligible Age

41 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Professor Fernando Figueira Integral Medicine Institute

OTHER

Sponsor Role lead

Responsible Party

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Professor Fernando Figueira Integral Medicine Institute

Principal Investigators

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Danielle Brandão

Role: PRINCIPAL_INVESTIGATOR

Professor Fernando Figueira Medicine Institute

Locations

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Danielle Cintra Bezerra Brandão

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Danielle Cintra Bezerra Brandão

Role: CONTACT

+558191427761

Facility Contacts

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Fernanda M Almeida, PhD

Role: primary

55 11 98945750

References

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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.

Reference Type DERIVED
PMID: 25234100 (View on PubMed)

Other Identifiers

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FernandoFigueiraIMI

Identifier Type: -

Identifier Source: org_study_id

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