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

Professor Fernando Figueira Integral Medicine Institute

Status and phase: Unknown; Phase 4

Conditions: Neonatal Hyperbilirubinemia

Treatments: Device: Phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01340339

FernandoFigueiraIMI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 35 to 41 weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

BILITRON BED®

Experimental group

Description:

Super-LED reverse phototherapy

Treatment:

Device: Phototherapy

Device: Phototherapy

BILIBERÇO®

Active Comparator group

Description:

Fluorescent Reverse Phototherapy

Treatment:

Device: Phototherapy

Device: Phototherapy