Neonatal Hyperbilirubinemia
Conditions
Keywords
Jaundice, Hyperbilirubinemia, Phototherapy and Super-LED Fluorescent lamps
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.
Interventions
DEVICEPhototherapy
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
Sponsors
Professor Fernando Figueira Integral Medicine Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Weeks to 41 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bilirubinemia | 24 hours | Bilirubin seric level decrease after 24 hours of phototherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phototherapy Time | 24 to 48 hours | 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 | 24 to 48 hours | If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions |
| Treatment Cost | 24 to 48 hours | number of lamps exchanges needed to maintain necessary irradiance |
| Treatment Failure | 24 to 48 hours | In cases in which increase in irradiance(\>30microwatts/cm2/nm) is needed to lower bilirubin levels. |
| Rebound Hyperbilirubinemia | 24 hours | Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart. |
Countries
Brazil
Contacts
Primary ContactDanielle Cintra Bezerra Brandão
Outcome results
None listed