Jaundice, NeonatalNCT01434810
Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
A study testing Filtered-sunlight phototherapy and Conventional phototherapy in people with Jaundice, Neonatal, run by University of Minnesota at 1 site in Nigeria.
Trial summary
The primary objective of this study is to determine the safety and efficacy of filtered sunlight phototherapy. Sunlight will be filtered by flexible (window-tinting) film. The subject population will be neonates born at Island Maternity Hospital, Lagos, Nigeria. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Jaundice, Neonatal
- What is being tested?
- Filtered-sunlight phototherapy and Conventional phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 1 siteNigeria
- Study dates
- Nov 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects will be eligible to participate in the study if all of the following conditions exist:
- At time of birth, infant is > 35 weeks gestation (or > 2.2 kg if gestational age is not available
- Infant is < 14 days old at the time of enrollment
- At time of enrollment, infant has an elevated TcB defined as 3 mg/dL below the level recommended for high-risk infants per AAP guidelines or higher
- Parent or guardian has given consent for the infant to participate
Who cannot join
- Subjects will be excluded from participation in the study if any of the following conditions exist at the time of enrollment:
- Infants with a condition requiring referral for treatment not available at the hospital study site and/or conventional phototherapy unit.
- Infants with a life-expectancy of < 24 hours
- Infants requiring oxygen therapy
- Infants clinically dehydrated or sunburned
- Infants with a temperature < 35.5 or > 38 degrees Centigrade
- Infants with ABE on clinical exam
- Infants meeting the criteria for EBT
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to determine the safety and efficacy of filtered sunlight phototherapy. Sunlight will be filtered by flexible (window-tinting) film. The subject population will be neonates born at Island Maternity Hospital, Lagos, Nigeria. The rationale for conducting the study is that in Nigeria, and other countries that may not have effective commercial light devices or have reliable access to electric power to operate them, filtered sunlight phototherapy might offer a safe and effective treatment for neonatal jaundice. Phase I of the study focused on the safety and efficacy of filtered sunlight phototherapy. Phase II of the study was a randomized controlled non-inferiority clinical trial comparing the efficacy of filtered sunlight phototherapy with conventional phototherapy.
Read the detailed description
Numerous studies from resource-limited countries suggest that severe neonatal jaundice (NNJ) represents the largest unrecognized cause of neonatal morbidity and mortality in the world. Several studies from Africa rank jaundice as a leading cause of death in newborn nurseries. In Nigeria, Owa and Osinaike reported that jaundice (14%) was the second leading cause of death, while Ugwu et al, found that mortality from severe jaundice was comparable to birth asphyxia but greater than sepsis in neonates >24 hrs old to 7 days old. In Kenya, English et al reported NNJ as the third leading cause of both newborn admissions and deaths. Studies from Nigeria, Zimbabwe, Turkey, North Vietnam, Oman, and India listed acute bilirubin encephalopathy (ABE) and/or severe NNJ as a significant cause of morbidity, many of whom required exchange blood transfusion (EBT) in their nurseries. Unfortunately, phototherapy, as important as it is, may not be available to many infants with NNJ in these countries because of the lack of devices and/or of unreliable electrical power supply. Commercial phototherapy (PT) devices are expensive, often break down due to surges in electrical power, and are difficult to maintain due to unavailability of spare parts. Even where PT devices are available, most hospitals in these countries lack the resources to replace the fluorescent light bulbs at the recommended 2000-3000 hrs of use and simply leave ineffective tubes in place until they burn out. Moreover, very few hospitals have appropriate irradiance meters for monitoring the intensity of the blue light emitted by the lamps. In a recent study in Nigeria by Owa et al, none of the tested PT devices provided the level of irradiance required for intensive PT.
Often, the only treatment a healthcare provider can suggest to the parents/guardians of jaundiced infants is to place their babies in sunlight. However, this practice is unsuitable due to several safety concerns. For instance, exposure to ultraviolet (UV) light may cause sunburn, while infrared (IR) light may cause the body to overheat. Moreover, the infant may lose body heat from the uncovered skin during treatment, with potential for dehydration. A safer, yet practical and economical, solution is needed, providing the basis for our proposal of filtered sunlight PT.
The primary aims of this study were safety, efficacy and non-inferiority of filtered sunlight phototherapy compared to conventional phototherapy. Phase I of the study focused on the safety and efficacy of filtered sunlight phototherapy. Phase II focused on non-inferiority of efficacy as compared to conventional phototherapy while continuing to evaluate safety.
- Conditions
- Jaundice, Neonatal
- Being tested
- Filtered-sunlight phototherapy, Conventional phototherapy
- Keywords
- Hyperbilirubinemia, Neonatal
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filtered-sunlight phototherapyDevice
Infants will receive six hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using window tinting film. Window tinting films by Solutia, Inc., and V-KOOL, Inc.
Conventional phototherapyDevice
Infants will receive six hours per day of conventional phototherapy for 1 to 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Filtered-sunlight phototherapy | Experimental | Infants will receive six hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using window tinting film. Window tinting films by Solutia, Inc., and V-KOOL, Inc. Receives: Device: Filtered-sunlight phototherapy |
| Conventional phototherapy | Active comparator | Infants will receive six hours per day of conventional phototherapy for 1 to 10 days. Receives: Device: Conventional phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Phototherapy
For a given treatment day, the phototherapy treatment was deemed safe if that infant on that day did not have to be withdrawn from treatment due to hypo- or hyperthermia, sunburn or dehydration. Therefore safety is reported as a percentage of the total treatment days (i.e. number of safe treatment days divided by total number of treatment days).
Measured: Four to ten days
Efficacy of Phototherapy
For a given evaluable treatment day, the phototherapy treatment was deemed effective if that infant on that day had a decrease in serum bilirubin level or (if <72hrs old) an rate of increase of less than 0.2 mg/dL/h. Therefore efficacy is reported as a percentage of the evaluable treatment days (i.e. number of effective evaluable treatment days divided by total number of evaluable treatment days).
Measured: Four to ten days
Secondary outcomes (1)
Number of Participants Requiring Exchange Blood Transfusion
Exchange blood transfusion required to lower the bilirubin level. Serum bilirubin will be measured twice daily during filtered sunlight or conventional phototherapy exposure, for an expected average of four days, and a maximum of ten days.
Measured: Four to ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Jaundice, NeonatalStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority trial comparing the two methods of phototherapy
- Masking
- None (open label)
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Tina M Slusher, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434810
- Sponsor's protocol ID
- 1108M03601
- Status last verified
- Jan 2019
- First submitted
- 30 Aug 2011
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Slusher TM, Olusanya BO, Vreman HJ, Brearley AM, Vaucher YE, Lund TC, Wong RJ, Emokpae AA, Stevenson DK. A Randomized Trial of Phototherapy with Filtered Sunlight in African Neonates. N Engl J Med. 2015 Sep 17;373(12):1115-24. doi: 10.1056/NEJMoa1501074.
PubMed 26376136Slusher TM, Olusanya BO, Vreman HJ, Wong RJ, Brearley AM, Vaucher YE, Stevenson DK. Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial. Trials. 2013 Dec 28;14:446. doi: 10.1186/1745-6215-14-446.
PubMed 24373547
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
- ClinicalTrials.gov ID
- NCT01434810
- Acronym / sponsor ID
- 1108M03601
- Conditions
- Jaundice, Neonatal
- Keywords
- Hyperbilirubinemia, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Nov 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Posted 5 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the safety and efficacy of filtered sunlight phototherapy. Sunlight will be filtered by flexible (window-tinting) film. The subject population will be neonates born at Island Maternity Hospital, Lagos, Nigeria. The rationale for conducting the study is that in Nigeria, and other countries that may not have effective commercial light devices or have reliable access to electric power to operate them, filtered sunlight phototherapy might offer a safe and effective treatment for neonatal jaundice. Phase I of the study focused on the safety and efficacy of filtered sunlight phototherapy. Phase II of the study was a randomized controlled non-inferiority clinical trial comparing the efficacy of filtered sunlight phototherapy with conventional phototherapy.
Detailed description
Numerous studies from resource-limited countries suggest that severe neonatal jaundice (NNJ) represents the largest unrecognized cause of neonatal morbidity and mortality in the world. Several studies from Africa rank jaundice as a leading cause of death in newborn nurseries. In Nigeria, Owa and Osinaike reported that jaundice (14%) was the second leading cause of death, while Ugwu et al, found that mortality from severe jaundice was comparable to birth asphyxia but greater than sepsis in neonates >24 hrs old to 7 days old. In Kenya, English et al reported NNJ as the third leading cause of both newborn admissions and deaths. Studies from Nigeria, Zimbabwe, Turkey, North Vietnam, Oman, and India listed acute bilirubin encephalopathy (ABE) and/or severe NNJ as a significant cause of morbidity, many of whom required exchange blood transfusion (EBT) in their nurseries. Unfortunately, phototherapy, as important as it is, may not be available to many infants with NNJ in these countries because of the lack of devices and/or of unreliable electrical power supply. Commercial phototherapy (PT) devices are expensive, often break down due to surges in electrical power, and are difficult to maintain due to unavailability of spare parts. Even where PT devices are available, most hospitals in these countries lack the resources to replace the fluorescent light bulbs at the recommended 2000-3000 hrs of use and simply leave ineffective tubes in place until they burn out. Moreover, very few hospitals have appropriate irradiance meters for monitoring the intensity of the blue light emitted by the lamps. In a recent study in Nigeria by Owa et al, none of the tested PT devices provided the level of irradiance required for intensive PT.
Often, the only treatment a healthcare provider can suggest to the parents/guardians of jaundiced infants is to place their babies in sunlight. However, this practice is unsuitable due to several safety concerns. For instance, exposure to ultraviolet (UV) light may cause sunburn, while infrared (IR) light may cause the body to overheat. Moreover, the infant may lose body heat from the uncovered skin during treatment, with potential for dehydration. A safer, yet practical and economical, solution is needed, providing the basis for our proposal of filtered sunlight PT.
The primary aims of this study were safety, efficacy and non-inferiority of filtered sunlight phototherapy compared to conventional phototherapy. Phase I of the study focused on the safety and efficacy of filtered sunlight phototherapy. Phase II focused on non-inferiority of efficacy as compared to conventional phototherapy while continuing to evaluate safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-inferiority trial comparing the two methods of phototherapy
| Arm | Type | Receives |
|---|---|---|
| Filtered-sunlight phototherapy | Experimental | Device: Filtered-sunlight phototherapyInfants will receive six hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using window tinting film. Window tinting films by Solutia, Inc., and V-KOOL, Inc. |
| Conventional phototherapy | Active comparator | Device: Conventional phototherapyInfants will receive six hours per day of conventional phototherapy for 1 to 10 days. |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects will be eligible to participate in the study if all of the following conditions exist:
- At time of birth, infant is > 35 weeks gestation (or > 2.2 kg if gestational age is not available
- Infant is < 14 days old at the time of enrollment
- At time of enrollment, infant has an elevated TcB defined as 3 mg/dL below the level recommended for high-risk infants per AAP guidelines or higher
- Parent or guardian has given consent for the infant to participate
Key exclusion criteria (8 listed)
- Subjects will be excluded from participation in the study if any of the following conditions exist at the time of enrollment:
- Infants with a condition requiring referral for treatment not available at the hospital study site and/or conventional phototherapy unit.
- Infants with a life-expectancy of < 24 hours
- Infants requiring oxygen therapy
- Infants clinically dehydrated or sunburned
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 |
|---|---|---|
| Filtered-sunlight phototherapyInfants will receive six hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using window tinting film. Window tinting films by Solutia, Inc., and V-KOOL, Inc. | Device | Filtered-sunlight phototherapy |
| Conventional phototherapyInfants will receive six hours per day of conventional phototherapy for 1 to 10 days. | Device | Conventional phototherapy |
Primary outcome
Safety of Phototherapy
Time frame: Four to ten days
For a given treatment day, the phototherapy treatment was deemed safe if that infant on that day did not have to be withdrawn from treatment due to hypo- or hyperthermia, sunburn or dehydration. Therefore safety is reported as a percentage of the total treatment days (i.e. number of safe treatment days divided by total number of treatment days).
Efficacy of Phototherapy
Time frame: Four to ten days
For a given evaluable treatment day, the phototherapy treatment was deemed effective if that infant on that day had a decrease in serum bilirubin level or (if <72hrs old) an rate of increase of less than 0.2 mg/dL/h. Therefore efficacy is reported as a percentage of the evaluable treatment days (i.e. number of effective evaluable treatment days divided by total number of evaluable treatment days).
1 secondary outcome
Number of Participants Requiring Exchange Blood Transfusion
Time frame: Four to ten days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26376136Slusher TM, Olusanya BO, Vreman HJ, Brearley AM, Vaucher YE, Lund TC, Wong RJ, Emokpae AA, Stevenson DK. A Randomized Trial of Phototherapy with Filtered Sunlight in African Neonates. N Engl J Med. 2015 Sep 17;373(12):1115-24. doi: 10.1056/NEJMoa1501074.
- Derived from this study: PubMed 24373547Slusher TM, Olusanya BO, Vreman HJ, Wong RJ, Brearley AM, Vaucher YE, Stevenson DK. Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial. Trials. 2013 Dec 28;14:446. doi: 10.1186/1745-6215-14-446.
- Individual participant dataSharing planned: No
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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.
Tina M Slusher, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filtered-sunlight phototherapy and Conventional phototherapy in people with Jaundice, Neonatal, run by University of Minnesota at 1 site in Nigeria.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 5 Feb 2019. 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 Nigeria. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Phototherapy (time frame: Four to ten days). The study lists 2 primary outcomes in all. 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 NCT01434810, which also lists 2 linked publications.
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 5 Feb 2019.