Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Professor Fernando Figueira Integral Medicine Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Professor Fernando Figueira Integral Medicine Institute
Information provided by:
Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier:
NCT01340339
First received: April 20, 2011
Last updated: April 21, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neonatal Hyperbilirubinemia |
Device: Phototherapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Reverse Phototherapy With Super Light-emitting Diode(Super-led) in Term and Late Preterm Infants:Randomized and Controlled Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Professor Fernando Figueira Integral Medicine Institute:
Primary Outcome Measures:
- Bilirubinemia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Bilirubin seric level decrease after 24 hours of phototherapy
Secondary Outcome Measures:
- Phototherapy Time [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]Number of hours needed to achieve a sufficiently low level of bilirubin that may allow suspension of phototherapy according to gestational age protocol.
- Adverse Effects [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions
- Treatment Cost [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]number of lamps exchanges needed to maintain necessary irradiance
- Treatment Failure [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]In cases in which increase in irradiance(>30microwatts/cm2/nm) is needed to lower bilirubin levels.
- Rebound Hyperbilirubinemia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart.
| Estimated Enrollment: | 144 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BILITRON BED®
Super-LED 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 Name: 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 Name: Fluorescent Light reverse phototherapy
|
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| Ages Eligible for Study: | 35 Weeks to 41 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340339
Contacts
| Contact: Danielle Cintra Bezerra Brandão | +558191427761 | daniellecbb@yahoo.com.br |
Locations
| Brazil | |
| Danielle Cintra Bezerra Brandão | Recruiting |
| Recife, Pernambuco, Brazil, 52030140 | |
| Contact: Fernanda M Almeida, PhD 55 11 98945750 fernandaalmeida@uol.com.br | |
| Principal Investigator: Danielle CB Brandao, postgraduate | |
Sponsors and Collaborators
Professor Fernando Figueira Integral Medicine Institute
Investigators
| Principal Investigator: | Danielle Brandão | Professor Fernando Figueira Medicine Institute |
More Information
No publications provided
| Responsible Party: | Danielle Cintra Bezerra Brandão, Professor Fernando Figueira Integral Medicine Institute |
| ClinicalTrials.gov Identifier: | NCT01340339 History of Changes |
| Other Study ID Numbers: | FernandoFigueiraIMI |
| Study First Received: | April 20, 2011 |
| Last Updated: | April 21, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Professor Fernando Figueira Integral Medicine Institute:
|
Jaundice Hyperbilirubinemia Phototherapy and Super-LED Fluorescent lamps |
Additional relevant MeSH terms:
|
Hyperbilirubinemia Hyperbilirubinemia, Neonatal Pathologic Processes Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 23, 2013