Corrigendum: Management challenges in the treatment of severe hyperbilirubinemia in low-and middle-income countries: encouraging advancements, remaining gaps, and future opportunities.

[This corrects the article DOI: 10.3389/fped.2023.1001141.].

Management challenges in the treatment of severe hyperbilirubinemia in low- and middle-income countries: Encouraging advancements, remaining gaps, and future opportunities.

Neonatal jaundice (NJ) is common in newborn infants. Severe NJ (SNJ) has potentially negative neurological sequelae that are largely preventable in high resource settings if timely diagnosis and treatment are provided. Advancements in NJ care in low- and middle-income countries (LMIC) have been made over recent years, especially with respect to an emphasis on parental education about the disease and technological advancements for improved diagnosis and treatment. Challenges remain, however, due to lack of routine screening for SNJ risk factors, fragmented medical infrastructure, and lack of culturally appropriate and regionally specific treatment guidelines. This article highlights both encouraging advancements in NJ care as well as remaining gaps. Opportunities are identified for future work in eliminating the gaps in NJ care and preventing death and disability related to SNJ around the globe.

Neonatal Eye Shielding during Phototherapy: What Protects the Eye Better?

BACKGROUND: Phototherapy remains an important component of the management of unconjugated neonatal jaundice, a major cause of newborn morbidity. During phototherapy the toxic unconjugated form of bilirubin is converted to nontoxic form through action of light delivered by phototherapy. An important possible complication of phototherapy is retinal damage and therefore eye protective measures are taken during therapy to prevent this from occurring. Devices currently in use for phototherapy are capable of providing intensive phototherapy with the attendant increased risk of eye injury. The materials used in providing eye protection are varied among care providers. A dearth of information exists on shielding provided by the commonly used eye protectors during phototherapy, more so during intensive phototherapy. OBJECTIVE: To evaluate the shielding provided by the different eye protectors commonly used in our setting under intensive phototherapy. MATERIALS AND METHOD: Five materials in use for eye shielding were obtained. Using an institutional built light emitting diode phototherapy device, intensive phototherapy was provided and the irradiance at varying distances of 35 cm, 25 cm, 15 cm and 10 cm was measured using an Olympic bili meterTM Natus. At the distance of each measured irradiance the different eye protective materials were then placed one after the other over the surface of the measuring sensor of the meter and the irradiance measurement was recorded. Two measurements were taken for each material at each distance and the average irradiance measurement was then recorded for each of the materials tested at that distance. RESULTS: Five eye shielding materials in use were identified: black cotton fabric, white cotton fabric, black cotton fabric with foam, white cotton fabric with foam and gauze. The black cotton fabric with or without foam at the phototherapy device irradiances of 30, 46.3, 58.7 and 75.4 µw/m2/nm recorded 0 irradiance. CONCLUSION: Black cotton fabric with or without foam pad provided the most shielding under intensive phototherapy.

Improving Effectiveness of Phototherapy in an Academic Center: A Quality Improvement Project.

Neonatal hyperbilirubinemia is a common cause of delayed discharge and readmissions in our institution. As previously published, the irradiance our phototherapy (PT) units provided was below the irradiance recommended by the AAP for intensive phototherapy (>30 µW/cm2/nm). We measured irradiance delivered by our PT units (Drager 4000) using a standardized footprint grid. By varying number of blue and white fluorescent PT lights, height of PT unit above the neonate and type of bed used (open bassinet versus isolette), we determined the optimal PT arrangement needed to deliver intensive PT (30 µW/cm2/nm). We then developed a standardized, multidisciplinary protocol specifying light arrangement and distance required needed to achieve the desired irradiance level. We were able to show improved irradiance following above changes. Onsite measurement of irradiance provided by local phototherapy units and development of a multidisciplinary, standardized protocol are necessary to assure delivery of recommended levels PT for neonates with hyperbilirubinemia.

Making Locally Fabricated Phototherapy Devices Work Better.

BACKGROUND: The efficiency of a phototherapy (PT) device is a function of the irradiance delivered by the device at the surface of the skin. Because cost limits the ability of health care facilities in low- and middle-income countries to procure commercial PT devices, efforts have gone into local fabrication of devices for use in health care facilities in Nigeria. Evaluation of such fabricated devices is yet to be conducted. OBJECTIVE: To identify and document essential features of locally fabricated phototherapy (FPT) devices in use in Nigeria. MATERIALS AND METHODS: A cross sectional survey of locally FPT devices available in health facilities providing newborn health care services was conducted as part of evaluating neonatal jaundice management services in Kaduna State. Each FPT was characterized with respect to mobility/portability, adjustability, lamp type, number and color of lamps used. The irradiance of each device was measured using Model 22 Olympic BiliMeter™ at the facility's traditional PT distance and also at a distance at which optimum irradiance is delivered by the device. RESULTS: A total of 54 PT devices were in use. Thirty-two (59.3%) of these devices were locally fabricated while others were obtained from commercial sources. Of the fabricated devices 22/32 (68.8%) were non-adjustable while the remaining 10 devices were adjustable but with limited adjustability. Only 5/32 (15.6%) of the FPT devices used special blue fluorescent lamps. The majority, 68.8% (22/32) of the FPT devices used ordinary low-intensity blue lamps while the remaining 5/32 (15.6%) devices used white light fluorescent lamps. None of the devices used light emitting diodes as a PT light source. Only three fabricated devices offered irradiance (9.4, 13.6 and 33 µW/cm2/nm) at the facilities' traditional distances for PT. CONCLUSIONS: FPT devices in use in Kaduna, functioned sub-optimally because of technically inadequate designs. The devices will need to be designed to especially enable adjustability to vary distance between device and patient's skin and the use of lamps which offer high irradiance.

Management of neonatal jaundice in low- and middle-income countries.

Abbreviations: ABE: acute bilirubin encephalopathy; ABR: auditory evoked brainstem response; BIND: bilirubin-induced neurological dysfunction; EBT: exchange blood transfusions; HIC: high-income countries; KSD: kernicterus spectrum disorder; LED: light-emitting diode; LMIC: low- and middle-income countries; SNH: severe neonatal jaundice or hyperbilirubinaemia; TcB: transcutaneous bilirubinometry; TSB: total serum bilirubin.

Filtered sunlight versus intensive electric powered phototherapy in moderate-to-severe neonatal hyperbilirubinaemia: a randomised controlled non-inferiority trial.

BACKGROUND: Kernicterus resulting from severe neonatal hyperbilirubinaemia is a leading cause of preventable deaths and disabilities in low-income and middle-income countries, partly because high-quality intensive phototherapy is unavailable. Previously, we showed that filtered-sunlight phototherapy (FSPT) was efficacious and safe for treatment of mild-to-moderate neonatal hyperbilirubinaemia. We aimed to extend these studies to infants with moderate-to-severe hyperbilirubinaemia. METHODS: We did a prospective, randomised controlled non-inferiority trial in Ogbomoso, Nigeria-a simulated rural setting. Near-term or term infants aged 14 days or younger who were of 35 weeks or more gestational age and with total serum bilirubin concentrations at or above the recommended age-dependent treatment levels for high-risk neonates were randomly assigned (1:1) to either FSPT or intensive electric phototherapy (IEPT). Randomisation was computer-generated, and neither clinicians nor the parents or guardians of participants were masked to group allocation. FSPT was delivered in a transparent polycarbonate room lined with commercial tinting films that transmitted effective phototherapeutic light, blocked ultraviolet light, and reduced infrared radiation. The primary outcome was efficacy, which was based on assessable treatment days only (ie, those on which at least 4 h of phototherapy was delivered) and defined as a rate of increase in total serum bilirubin concentrations of less than 3·4 µmol/L/h in infants aged 72 h or younger, or a decrease in total serum bilirubin concentrations in those older than 72 h. Safety was defined as no sustained hypothermia, hyperthermia, dehydration, or sunburn and was based on all treatment days. Analysis was by intention to treat with a non-inferiority margin of 10%. FINDINGS: Between July 31, 2015, and April 30, 2017, 174 neonates were enrolled and randomly assigned: 87 to FSPT and 87 to IEPT. Neonates in the FSPT group received 215 days of phototherapy, 82 (38%) of which were not assessable. Neonates in the IEPT group received 219 treatment days of phototherapy, 67 (31%) of which were not assessable. Median irradiance was 37·3 µW/cm2/nm (IQR 21·4-56·4) in the FSPT group and 50·4 µW/cm2/nm (44·5-66·2) in the IEPT group. FSPT was efficacious on 116 (87·2%) of 133 treatment days; IEPT was efficacious on 135 (88·8%) of 152 treatment days (mean difference -1·6%, 95% CI -9·9 to 6·7; p=0·8165). Because the CI did not extend below -10%, we concluded that FSPT was not inferior to IEPT. Treatment was safe for all neonates. INTERPRETATION: FSPT is safe and no less efficacious than IEPT for treatment of moderate-to-severe neonatal hyperbilirubinaemia in near-term and term infants. FUNDING: Thrasher Research Fund and National Center for Advancing Translational Sciences.

Variation in the Phototherapy Practices and Irradiance of Devices in a Major Metropolitan Area.

BACKGROUND: Phototherapy (PT) is widely used to prevent and treat severe hyperbilirubinemia and its associated risks for both acute and chronic bilirubin encephalopathy. Intensive PT, recommended for inpatient treatment of hyperbilirubinemia in term and near-term infants, is defined as having a spectral irradiance of ≥30 µW/cm2/nm. OBJECTIVES: We aimed to assess local PT practices by measuring the irradiance of PT devices in local neonatal intensive care units and newborn nurseries. METHODS: The irradiance footprint, including maximum irradiance at the center of the footprint, of 39 PT devices in 7 area hospitals was measured according to current practice in these facilities. RESULTS: The mean ± SD (range) footprint irradiance was 20.7 ± 5.8 (8.8-29.4) µW/cm2/nm. The mean ± SD maximum irradiance at the footprint center for all devices at a mean clinically used treatment distance of 33.1 ± 9.3 (25.5-60.0) cm was 27.8 ± 7.0 (14.7-42.0) µW/cm2/nm. Sixty-two percent of the devices did not meet the minimum recommended spectral irradiance for intensive PT. For the sites without irradiance-based protocols, the maximum irradiance of the devices (n = 33) at the treatment distances was 25.8 ± 6.1 µW/cm2/nm. CONCLUSIONS: Despite established PT guidelines, local protocols and practices vary. Based on an assessment of 7 local hospitals, intensive PT was suboptimal for 62% of devices. Straightforward changes, such as decreasing the distance between an infant and the light source and establishing a consistent irradiance-based protocol, could substantially improve the quality of the intervention.

Filtered sunlight, solar powered phototherapy and other strategies for managing neonatal jaundice in low-resource settings.

Challenges in treating severe neonatal jaundice in low and middle-income country settings still exist at many levels. These include: a lack of awareness of causes and prevention by families, communities and even sometimes health care professionals; insufficient, ineffective, high quality affordable diagnostic and therapeutic options; limited availability of rehabilitation provision for kernicterus. Collectively these challenges lead to an unacceptably high global morbidity and mortality from severe neonatal jaundice. In the past decade, there has been an explosion of innovations addressing some of these issues and these are increasingly available for scale up. Scientists, healthcare providers, and communities are joining hands to explore educational tools, low cost screening and diagnostic options including at point-of-care and treatment modalities including filtered sunlight and solar powered phototherapy. For the first time, the possibility of eliminating the tragedy of preventable morbidity and mortality from severe NNJ is on the horizon, for all.

Maternal detection of neonatal jaundice during birth hospitalization using a novel two-color icterometer.

BACKGROUND: Mothers are frequently the first to observe the onset of jaundice in their newborn infants before the decision to seek treatment. However, simple-to-use tools that could facilitate early detection of jaundice and assist mothers to seek professional care, especially after hospital discharge, are rare. This study therefore, set out to evaluate the performance of a -two-color icterometer (Bilistrip™) as a possible screening tool for detecting significant jaundice by mothers or care-givers in the first week of life. METHODS: Prior to discharge, mothers in a maternity hospital were trained to use the Bilistrip™ on the blanched skin of their baby's nose to ascertain absence (Light Yellow) or presence (Dark Yellow) of significant jaundice. Their babies had transcutaneous bilirubin (TcB) measurements independently, along with total serum bilirubin (TSB) if indicated. The reliability of Bilistrip™ as a screening test for significant jaundice was determined at different TcB and TSB thresholds. The predictive performance of Bilistrip™ was also evaluated with multivariable logistic regression. RESULTS: Some 2492 mother-infant pairs were enrolled over 15 months, of which 347 (13.9%) chose Dark Yellow. The mean TcB for Dark Yellow (10mg/dL) was significantly higher (p<0.001) than for Light Yellow (6.1mg/dL). Bilistrip™ showed increasing sensitivity (47.0% - 92.6%) and negative predictive value (NPV) (91.4% - 99.9%) for selected TcB thresholds (≥10mg/dL, ≥12mg/dL, ≥15mg/dL, and ≥17mg/dL). Among neonates with TSB measurements (n = 124), Bilistrip™ was associated also with increasing sensitivity (86.8% - 100%) and NPV (62.5% - 100%). The sensitivity and NPV for detecting neonates requiring phototherapy were 95.8% respectively. Only one of the 24 neonates who required phototherapy was missed by the Bilistrip™. CONCLUSIONS: Bilistrip™ is a potential decision-making tool for empowering mothers to detect neonates with clinically significant jaundice that may require close monitoring or treatment, and neonates not requiring treatment for jaundice in the first week of life.

Irradiance Decay in Fluorescent and Light-emitting Diode-based Phototherapy Devices: A Pilot Study.

We set out to determine the rate of decline of irradiance for fluorescent tube (FT) and light-emitting diode (LED) phototherapy devices in resource-limited settings where routine irradiance monitoring is uncommon. Irradiance levels (µW/cm(2)/nm) were measured weekly using BiliBlanket(®) II Meter on three FT-based and two LED-based phototherapy devices over a 19 week period. The two LED devices showed stable irradiance levels and did not require any lamp changes. The three FT-based devices showed rapid decline in irradiance, and all required three complete lamp exchanges approximately every 5-6 weeks. FT-based devices are associated with more rapid decline in irradiance to sub-therapeutic levels and require more frequent lamp changes than LED devices. Clinicians should be alert to the maintenance requirements of the phototherapy devices available in their settings to ensure efficacy of treatment.

A Randomized Trial of Phototherapy with Filtered Sunlight in African Neonates.

BACKGROUND: Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable. We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin. However, its relative safety and efficacy as compared with conventional phototherapy are unknown. METHODS: We conducted a randomized, controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large, urban Nigerian maternity hospital. The primary end point was efficacy, which was defined as a rate of increase in total serum bilirubin of less than 0.2 mg per deciliter per hour for infants up to 72 hours of age or a decrease in total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy; we prespecified a noninferiority margin of 10% for the difference in efficacy rates between groups. The need for an exchange transfusion was a secondary end point. We also assessed safety, which was defined as the absence of the need to withdraw therapy because of hyperthermia, hypothermia, dehydration, or sunburn. RESULTS: We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy. Filtered sunlight was efficacious on 93% of treatment days that could be evaluated, as compared with 90% for conventional phototherapy, and had a higher mean level of irradiance (40 vs. 17 µW per square centimeter per nanometer, P<0.001). Temperatures higher than 38.0°C occurred in 5% of the infants receiving filtered sunlight and in 1% of those receiving conventional phototherapy (P<0.001), but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion. CONCLUSIONS: Filtered sunlight was noninferior to conventional phototherapy for the treatment of neonatal hyperbilirubinemia and did not result in any study withdrawals for reasons of safety. (Funded by the Thrasher Research Fund, Salt Lake City, and the National Center for Advancing Translational Sciences of the National Institutes of Health; Clinical Trials.gov number, NCT01434810.).

Management of late-preterm and term infants with hyperbilirubinaemia in resource-constrained settings.

Hyperbilirubinaemia is a ubiquitous transitional morbidity in the vast majority of newborns and a leading cause of hospitalisation in the first week of life worldwide. While timely and effective phototherapy and exchange transfusion are well proven treatments for severe neonatal hyperbilirubinaemia, inappropriate or ineffective treatment of hyperbilirubinaemia, at secondary and tertiary hospitals, still prevails in many poorly-resourced countries accounting for a disproportionately high burden of bilirubin-induced mortality and long-term morbidity. As part of the efforts to curtail the widely reported risks of frequent but avoidable bilirubin-induced neurologic dysfunction (acute bilirubin encephalopathy (ABE) and kernicterus) in low and middle-income countries (LMICs) with significant resource constraints, this article presents a practical framework for the management of late-preterm and term infants (≥ 35 weeks of gestation) with clinically significant hyperbilirubinaemia in these countries particularly where local practice guidelines are lacking. Standard and validated protocols were followed in adapting available evidence-based national guidelines on the management of hyperbilirubinaemia through a collaboration among clinicians and experts on newborn jaundice from different world regions. Tasks and resources required for the comprehensive management of infants with or at risk of severe hyperbilirubinaemia at all levels of healthcare delivery are proposed, covering primary prevention, early detection, diagnosis, monitoring, treatment, and follow-up. Additionally, actionable treatment or referral levels for phototherapy and exchange transfusion are proposed within the context of several confounding factors such as widespread exclusive breastfeeding, infections, blood group incompatibilities and G6PD deficiency, which place infants at high risk of severe hyperbilirubinaemia and bilirubin-induced neurologic dysfunction in LMICs, as well as the limited facilities for clinical investigations and inconsistent functionality of available phototherapy devices. The need to adjust these levels as appropriate depending on the available facilities in each clinical setting and the risk profile of the infant is emphasised with a view to avoiding over-treatment or under-treatment. These recommendations should serve as a valuable reference material for health workers, guide the development of contextually-relevant national guidelines in each LMIC, as well as facilitate effective advocacy and mobilisation of requisite resources for the optimal care of infants with hyperbilirubinaemia at all levels.

Why is kernicterus still a major cause of death and disability in low-income and middle-income countries?

Neonatal jaundice is predominantly a benign condition that affects 60%-80% of newborns worldwide but progresses to potentially harmful severe hyperbilirubinaemia in some. Despite the proven therapeutic benefits of phototherapy for preventing extreme hyperbilirubinaemia, acute bilirubin encephalopathy or kernicterus, several low-income and middle-income countries (LMIC) continue to report high rates of avoidable exchange transfusions, as well as bilirubin-induced mortality and neurodevelopmental disorders. Considering the critical role of appropriate timing in treatment effectiveness, this review set out to examine the contributory factors to the burden of severe hyperbilirubinaemia and kernicterus based on the 'three delays model' described by Thaddeus and Maine in the 91 most economically disadvantaged LMICs with Gross National Income per capita ≤US$6000 and median human development index of 0.525 (IQR: 0.436-0.632). Strategies for addressing these delays are proposed including the need for clinical and public health leadership to curtail the risk and burden of kernicterus in LMICs.

Addressing the burden of neonatal hyperbilirubinaemia in countries with significant glucose-6-phosphate dehydrogenase deficiency.

UNLABELLED: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an established worldwide risk factor for severe hyperbilirubinaemia. This literature review examined the pattern and management of severe hyperbilirubinaemia in low- and middle-income countries (LMICs) where G6PD deficiency was 10% or more and found that it was frequently associated with neonatal mortality and, or, neurodevelopmental disorders. CONCLUSION: Low- and middle-income countries need to pay urgent attention to G6PD deficiency to curtail the preventable burden of jaundice-related morbidity, mortality and disability.

Maternal satisfaction with a novel filtered-sunlight phototherapy for newborn jaundice in Southwest Nigeria.

BACKGROUND: In many resource-limited settings, the availability of effective phototherapy for jaundiced infants is frequently hampered by lack of, or inadequate resources to acquire and maintain conventional electric-powered phototherapy devices. This study set out to ascertain maternal experience and satisfaction with a novel treatment of infants with significant hyperbilirubinemia using filtered sunlight phototherapy (FSPT) in a tropical setting with irregular access to effective conventional phototherapy. METHODS: A cross-sectional satisfaction survey was conducted among mothers of jaundiced infants treated with FSPT in an inner-city maternity hospital in Lagos, Nigeria from November 2013 to March 2014. Mothers' experience during treatment was elicited with a pretested questionnaire consisting of closed and open-ended items. Satisfaction was rated on a five-point Likert scale. Correlates of overall maternal satisfaction were explored with descriptive and inferential non-parametric statistics. RESULTS: A total of 191 mothers were surveyed, 77 (40%) of whom had no prior knowledge of neonatal jaundice. Maternal satisfaction was highest for quality of nursing care received (mean: 4.72 ± 0.55, median: 5[IQR: 5-5]) and lowest for physical state of the test environment (mean: 3.85 ± 0.74, median: 4[IQR: 3-4]). The overall rating (mean: 4.17 ± 0.58, median: 4[IQR: 4-5]) and the observed effect of FSPT on the babies (mean: 4.34 ± 0.58, 4[IQR: 4-5]) were quite satisfactory. FSPT experience was significantly correlated with the adequacy of information received (p < 0.0005), test environment (p = 0.002) and the observed effect of FSPT on the child (p < 0.0005). Almost all mothers (98.4%) indicated willingness to use FSPT in future or recommend it to others, although some (30 or 15.7%) disliked the idea of exposing newborns to sunlight. CONCLUSIONS: Mothers of jaundiced newborns in this population are likely to be satisfied with FSPT where it is inevitable as an alternative to conventional electric-powered phototherapy. Adequate information, good test environment and friendly nursing care must be ensured for satisfactory maternal experience.

Safety and efficacy of filtered sunlight in treatment of jaundice in African neonates.

OBJECTIVES: Evaluate safety and efficacy of filtered-sunlight phototherapy (FS-PT). METHODS: Term/late preterm infants #14 days old with clinically significant jaundice, assessed by total bilirubin (TB) levels, were recruited from a maternity hospital in Lagos, Nigeria. Sunlight was filtered with commercial window-tinting films that remove most UV and significant levels of infrared light and transmit effective levels of therapeutic blue light. After placing infants under an FS-PT canopy, hourly measurements of axillary temperatures, monitoring for sunburn, dehydration, and irradiances of filtered sunlight were performed. Treatment was deemed safe and efficacious if infants were able to stay in FS-PT for $5 hours and rate of rise of TB was ,0.2 mg/dL/h for infants #72 hours of age or TB decreased for infants .72 hours of age. RESULTS: A total of 227 infants received 258 days of FS-PT. No infant developed sunburn or dehydration. On 85 (33%) of 258 treatment days, infants were removed briefly from FS-PT due to minor temperature-related adverse events. No infant met study exit criteria. FS-PT was efficacious in 92% (181/197) of evaluable treatment days. Mean 6 SD TB change was ­0.06 6 0.19 mg/dL/h. The mean 6 SD (range) irradiance of FS-PT was 38 6 22 (2­115) mW/cm2/nm, measured by the BiliBlanket Meter II. CONCLUSIONS: With appropriate monitoring, filtered sunlight is a novel, practical, and inexpensive method of PT that potentially offers safe and efficacious treatment strategy for management of neonatal jaundice in tropical countries where conventional PT treatment is not available.

Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial.

BACKGROUND: Severe neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries, particularly in sub-Saharan Africa. The standard treatment for jaundice using conventional phototherapy (CPT) with electric artificial blue light sources is often hampered by the lack of (functional) CPT devices due either to financial constraints or erratic electrical power. In an attempt to make phototherapy (PT) more readily available for the treatment of pathologic jaundice in underserved tropical regions, we set out to test the hypothesis that filtered sunlight phototherapy (FS-PT), in which potentially harmful ultraviolet and infrared rays are appropriately screened, will be as efficacious as CPT. METHODS/DESIGN: This prospective, non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin (TSB, defined as 3 mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT) who will be randomly and equally assigned to receive FS-PT or CPT for a total of 616 days at an inner-city maternity hospital in Lagos, Nigeria. Two FS-PT canopies with pre-tested films will be used. One canopy with a film that transmits roughly 33% blue light (wavelength range: 400 to 520 nm) will be used during sunny periods of a day. Another canopy with a film that transmits about 79% blue light will be used during overcast periods of the day. The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above 8 µW/cm²/nm. PRIMARY OUTCOME: FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels. Secondary outcome: The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT. CONCLUSION: This novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in poorly-resourced settings without access to (reliable) CPT in the tropics. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01434810.