Clinical trial NCT01340339: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neonatal Hyperbilirubinemia
Keywords: Jaundice
Hyperbilirubinemia
Phototherapy and Super-LED Fluorescent lamps
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
First posted: 2011-04-22
Enrollment: 144
Sex: ALL
Minimum age (years): 35
Maximum age (years): 41
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bilirubinemia
timeFrame: 24 hours
Secondary outcomes:
measure: Phototherapy Time
timeFrame: 24 to 48 hours
measure: Adverse Effects
timeFrame: 24 to 48 hours
measure: Treatment Cost
timeFrame: 24 to 48 hours
measure: Treatment Failure
timeFrame: 24 to 48 hours
measure: Rebound Hyperbilirubinemia
timeFrame: 24 hours
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Danielle Cintra Bezerra Brandão
state: Pernambuco
Study officials:
affiliation: Professor Fernando Figueira Medicine Institute
name: Danielle Brandão
role: PRINCIPAL_INVESTIGATOR
References:
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.