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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BILITRON BED® | Experimental | Super-LED reverse phototherapy |
|
| BILIBERÇO® | Active Comparator | Fluorescent Reverse Phototherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phototherapy | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bilirubinemia | Bilirubin seric level decrease after 24 hours of phototherapy | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adverse Effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Cintra Bezerra Brandão | Contact | +558191427761 | daniellecbb@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Danielle Brandão | Professor Fernando Figueira Medicine Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danielle Cintra Bezerra Brandão | Recruiting | Recife | Pernambuco | 52030140 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25234100 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 1, 2013 | |
| Unrelease | Yes | |
| Release | Jun 6, 2013 | |
| Unrelease | Yes | |
| Release | Jun 8, 2013 | |
| Reset | Aug 12, 2013 | |
| Release | Aug 22, 2013 | |
| Unrelease | Yes | |
| Release | Oct 17, 2013 | |
| Reset | Dec 10, 2013 | |
| Release | Aug 6, 2014 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2013 | Yes | |||
| Jun 6, 2013 |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007565 | Jaundice |
| D006932 | Hyperbilirubinemia |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Phototherapy | 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 |
|
|
If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions
| 24 to 48 hours |
| Treatment Cost | number of lamps exchanges needed to maintain necessary irradiance | 24 to 48 hours |
| Treatment Failure | In cases in which increase in irradiance(>30microwatts/cm2/nm) is needed to lower bilirubin levels. | 24 to 48 hours |
| Rebound Hyperbilirubinemia | Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart. | 24 hours |
| Yes |
| Jun 8, 2013 | Aug 12, 2013 |
| Aug 22, 2013 | Yes |
| Oct 17, 2013 | Dec 10, 2013 |
| Aug 6, 2014 | Yes |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |