Neonatal HyperbilirubinemiaPhase 4NCT01340339
Reverse Phototherapy With Super Light-emitting Diode(Super-LED) for Hyperbilirubinemia in Term and Late Preterm Infants
A Phase 4 study testing Phototherapy in people with Neonatal Hyperbilirubinemia, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 35 to 41 weeks
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 41 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Danielle Cintra Bezerra Brandão
Recife, Pernambuco, 52030140
Fernanda M Almeida, PhD, 55 11 98945750, fernandaalmeida@uol.com.br
Danielle CB Brandao, postgraduate
About this study
Official title: Efficacy of Reverse Phototherapy With Super Light-emitting Diode(Super-led) in Term and Late Preterm Infants:Randomized and Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Phototherapy
- Keywords
- Jaundice, Hyperbilirubinemia, Phototherapy and Super-LED Fluorescent lamps
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyDevice
Also called Fluorescent Light reverse 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
PhototherapyDevice
Also called Super-LED reverse 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
| Study group | Role | What they receive |
|---|---|---|
| BILITRON BED® | Experimental | Super-LED reverse phototherapy Receives: Device: Phototherapy |
| BILIBERÇO® | Active comparator | Fluorescent Reverse Phototherapy Receives: Device: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilirubinemia
Bilirubin seric level decrease after 24 hours of phototherapy
Measured: 24 hours
Secondary outcomes (5)
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.
Measured: 24 to 48 hours
Adverse Effects
If any of the following are presented: weight loss, hypothermia or hyperthermia and/or skin lesions
Measured: 24 to 48 hours
Treatment Cost
number of lamps exchanges needed to maintain necessary irradiance
Measured: 24 to 48 hours
Treatment Failure
In cases in which increase in irradiance(>30microwatts/cm2/nm) is needed to lower bilirubin levels.
Measured: 24 to 48 hours
Rebound Hyperbilirubinemia
Increased bilirubin seric levels, after suspension of phototherapy, with clinical necessity of phototherapy restart.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Investigators
- Danielle Brandão, Principal investigator, Professor Fernando Figueira Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340339
- Sponsor's protocol ID
- FernandoFigueiraIMI
- Status last verified
- Apr 2011
- First submitted
- 20 Apr 2011
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25234100
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Reverse Phototherapy With Super Light-emitting Diode(Super-led) in Term and Late Preterm Infants:Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01340339
- Acronym / sponsor ID
- FernandoFigueiraIMI
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- Jaundice, Hyperbilirubinemia, Phototherapy and Super-LED Fluorescent lamps
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 22 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BILITRON BED® | Experimental | Device: PhototherapySuper-LED reverse phototherapy |
| BILIBERÇO® | Active comparator | Device: PhototherapyFluorescent Reverse Phototherapy |
Who may qualify
- Ages
- 35 to 41 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhototherapyAlso: Fluorescent Light reverse phototherapyFluorescent 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 | Device | BILIBERÇO® |
| PhototherapyAlso: Super-LED reverse phototherapysuper 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 | Device | BILITRON BED® |
Primary outcome
Bilirubinemia
Time frame: 24 hours
Bilirubin seric level decrease after 24 hours of phototherapy
5 secondary outcomes
Phototherapy Time
Time frame: 24 to 48 hours
Adverse Effects
Time frame: 24 to 48 hours
Treatment Cost
Time frame: 24 to 48 hours
Treatment Failure
Time frame: 24 to 48 hours
Rebound Hyperbilirubinemia
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2011.
- Derived from this study: PubMed 25234100Brandao 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Brandão principal investigator
Professor Fernando Figueira Medicine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phototherapy in people with Neonatal Hyperbilirubinemia, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danielle Cintra Bezerra Brandão (+558191427761, daniellecbb@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilirubinemia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01340339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2011.