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

Neonatal Hyperbilirubinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01340339
• Other study ID #: FernandoFigueiraIMI
• Status: Unknown status
• Phase: Phase 4
• First received: April 20, 2011
• Last updated: April 21, 2011
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: April 2011
• Source: Professor Fernando Figueira Integral Medicine Institute
• Contact: Danielle Cintra Bezerra Brandão
• Phone: +558191427761
• Email: daniellecbb[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 144
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks to 41 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Danielle Cintra Bezerra Brandão	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Professor Fernando Figueira Integral Medicine Institute

Country where clinical trial is conducted

Brazil, 

Outcome

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