Jaundice, NeonatalFSPTNCT02612727
Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates
A study testing Filtered-sunlight phototherapy and Intensive phototherapy in people with Jaundice, Neonatal, run by University of Minnesota at 1 site in Nigeria.
Trial summary
At present, much of sub-Saharan Africa, including Nigeria and other resource-limited countries, are without ready access to CPT, due to factors including the lack of PT devices, which are expensive and require consistent electric power to operate. 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 Intensive phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteNigeria
- Study dates
- Nov 2012to 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.
- Infant has an elevated TB defined as at 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 enrollment in the study if any of the following conditions exist:
- Infants with a condition requiring referral for treatment not available at the hospital study site.
- Infants with a life-expectancy of < 24 hours at screening enrollment.
- Infants requiring oxygen therapy unless that can be provided while under PT.
- Infants clinically dehydrated or sunburned at the time of screening enrollment.
- Infants with a temperature < 36.0 or > 37.5 degrees Centigrade that does not return to normothermia within 1 hour.
Trial locations and contacts
1 site in 1 country.
About this study
At present, much of sub-Saharan Africa, including Nigeria and other resource-limited countries, are without ready access to CPT, due to factors including the lack of PT devices, which are expensive and require consistent electric power to operate. NHB is a significant cause of neonatal morbidity and mortality, but preventable when appropriate treatment is initiated. We have shown that FS-PT is safe and efficacious for the treatment of mild-moderate NHB. The major goal of this study is to demonstrate that FS-PT is efficacious for the treatment of significant/severe NHB, generally defined as TB of ≥12-14mg/dL (but more specially as defined as needing phototherapy per American Academy of Pediatric 2004 guidelines). This arm was done at 1 site in Nigeria (in Ogbomoso). The rationale for conducting the study is that in Nigeria, and other countries that cannot afford effective commercial light devices and/or have no reliable electric power to operate them, filtered sunlight phototherapy might offer a safe and effective treatment for neonatal jaundice.
Read the detailed description
Severe neonatal hyperbilirubinemia (NHB) and its progression to kernicterus is a leading cause of deaths and disabilities among newborns in the developing world, particularly in sub-Saharan Africa including Nigeria. Many infants live in villages/towns far from clinical facilities capable of providing conventional artificial blue light phototherapy (CPT) which is the standard treatment for NHB in the industrialized world. Hence, more babies succumb to this preventable tragedy principally on account of lack of electricity and/or available/affordable CPT.
To make treatment of NHB more readily available, we designed and tested a novel, yet simple, practical alternative device to deliver blue light PT in underserved areas from filtered sunlight. The investigators pilot study demonstrated that appropriately filtered sunlight phototherapy (FS-PT) not only offers safe and affordable treatment for infants with mild-moderate NHB, but is also no less efficacious than CPT. Other studies have shown faster decline at higher bilirubin (TB) levels and with higher irradiances. The next logical step to move this urgently needed and exciting therapy forward is to test FS-PT in infants with significant/severe NHB as defined by the American Academy of Pediatrics (AAP) criteria for high-risk infants. In doing so, the investigators will potentially be preventing acute bilirubin encephalopathy (ABE) and kernicterus in many of these infants.
- Conditions
- Jaundice, Neonatal
- Being tested
- Filtered-sunlight phototherapy, Intensive 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 >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.
Intensive phototherapyDevice
Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Filtered-sunlight phototherapy | Experimental | Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film. Receives: Device: Filtered-sunlight phototherapy |
| Intensive phototherapy | Active comparator | Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days. Receives: Device: Intensive phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 2 to 10 days
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: 2 to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2012
- 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
- 174 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, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612727
- Sponsor's protocol ID
- 1108M03601_Phase 2
- Acronym
- FSPT
- Status last verified
- Jun 2019
- First submitted
- 20 Oct 2015
- Last updated
- 9 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olusanya BO, Omololu OM, Osamebor FB, Olufosoye A, Alo T, Olaifa SM, Emokpae AA, Olusanya JO, Mabogunje CA. Filtered-sunlight phototherapy for newborns with moderate-to-severe hyperbilirubinemia: a randomized trial. Pediatr Res. 2026 Jan;99(1):174-182. doi: 10.1038/s41390-025-04207-6. Epub 2025 Jun 28.
PubMed 40581699Olusanya BO, Emokpae AA, Aina OA, Imam ZO, Olaifa SM, Owolabi OB, Osamebor FB, Olufosoye A, Alo T, Osadolor A Jr, Olusanya JO, Mabogunje CA. Heliotherapy for neonates with severe-to-hazardous hyperbilirubinemia: a randomized controlled, non-inferiority trial. Sci Rep. 2024 Oct 27;14(1):25646. doi: 10.1038/s41598-024-77085-3.
PubMed 39465350
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates
- ClinicalTrials.gov ID
- NCT02612727
- Acronym / sponsor ID
- FSPT / 1108M03601_Phase 2
- Conditions
- Jaundice, Neonatal
- Keywords
- Hyperbilirubinemia, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present, much of sub-Saharan Africa, including Nigeria and other resource-limited countries, are without ready access to CPT, due to factors including the lack of PT devices, which are expensive and require consistent electric power to operate. NHB is a significant cause of neonatal morbidity and mortality, but preventable when appropriate treatment is initiated. We have shown that FS-PT is safe and efficacious for the treatment of mild-moderate NHB. The major goal of this study is to demonstrate that FS-PT is efficacious for the treatment of significant/severe NHB, generally defined as TB of ≥12-14mg/dL (but more specially as defined as needing phototherapy per American Academy of Pediatric 2004 guidelines). This arm was done at 1 site in Nigeria (in Ogbomoso). The rationale for conducting the study is that in Nigeria, and other countries that cannot afford effective commercial light devices and/or have no reliable electric power to operate them, filtered sunlight phototherapy might offer a safe and effective treatment for neonatal jaundice.
Detailed description
Severe neonatal hyperbilirubinemia (NHB) and its progression to kernicterus is a leading cause of deaths and disabilities among newborns in the developing world, particularly in sub-Saharan Africa including Nigeria. Many infants live in villages/towns far from clinical facilities capable of providing conventional artificial blue light phototherapy (CPT) which is the standard treatment for NHB in the industrialized world. Hence, more babies succumb to this preventable tragedy principally on account of lack of electricity and/or available/affordable CPT.
To make treatment of NHB more readily available, we designed and tested a novel, yet simple, practical alternative device to deliver blue light PT in underserved areas from filtered sunlight. The investigators pilot study demonstrated that appropriately filtered sunlight phototherapy (FS-PT) not only offers safe and affordable treatment for infants with mild-moderate NHB, but is also no less efficacious than CPT. Other studies have shown faster decline at higher bilirubin (TB) levels and with higher irradiances. The next logical step to move this urgently needed and exciting therapy forward is to test FS-PT in infants with significant/severe NHB as defined by the American Academy of Pediatrics (AAP) criteria for high-risk infants. In doing so, the investigators will potentially be preventing acute bilirubin encephalopathy (ABE) and kernicterus in many of these infants.
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 >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film. |
| Intensive phototherapy | Active comparator | Device: Intensive phototherapyInfants will receive >= four hours per day of intensive 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:
Key exclusion criteria (6 listed)
- Subjects will be excluded from enrollment in the study if any of the following conditions exist:
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 >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film. | Device | Filtered-sunlight phototherapy |
| Intensive phototherapyInfants will receive >= four hours per day of intensive phototherapy for 1 to 10 days. | Device | Intensive phototherapy |
Primary outcome
Efficacy of Phototherapy
Time frame: 2 to 10 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).
Safety of Phototherapy
Time frame: 2 to 10 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40581699Olusanya BO, Omololu OM, Osamebor FB, Olufosoye A, Alo T, Olaifa SM, Emokpae AA, Olusanya JO, Mabogunje CA. Filtered-sunlight phototherapy for newborns with moderate-to-severe hyperbilirubinemia: a randomized trial. Pediatr Res. 2026 Jan;99(1):174-182. doi: 10.1038/s41390-025-04207-6. Epub 2025 Jun 28.
- Derived from this study: PubMed 39465350Olusanya BO, Emokpae AA, Aina OA, Imam ZO, Olaifa SM, Owolabi OB, Osamebor FB, Olufosoye A, Alo T, Osadolor A Jr, Olusanya JO, Mabogunje CA. Heliotherapy for neonates with severe-to-hazardous hyperbilirubinemia: a randomized controlled, non-inferiority trial. Sci Rep. 2024 Oct 27;14(1):25646. doi: 10.1038/s41598-024-77085-3.
- 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 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 Intensive 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 6 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 9 Jul 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 19 Jun 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?
Efficacy of Phototherapy (time frame: 2 to 10 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 NCT02612727, 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 9 Jul 2019.