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.

Use of Transcutaneous Bilirubin to Determine the Need for Phototherapy in Resource-Limited Settings.

BACKGROUND: Routine and timely determination of total serum bilirubin (TSB) remains a challenge in many resource-limited countries with substantial burden of severe neonatal hyperbilirubinemia. Limited evidence exists on the potential usefulness of transcutaneous bilirubin (TcB) to identify infants who may require phototherapy based on possible treatment criteria in such settings. OBJECTIVE: To compare the number of infants requiring phototherapy across different TSB criteria and determine the predictive performance of TcB under each criterion. METHODS: Infants with paired TcB and TSB measurements in a maternity hospital in Lagos, Nigeria, were assessed for phototherapy based on TSB criteria by the American Academy of Pediatrics (AAP), National Institute for Health and Clinical Excellence (NICE) UK, and World Health Organization (WHO), and an absolute threshold of ≥12 mg/dL. The predictive performance of TcB across treatment criteria was evaluated with receiver operating curve analysis. RESULTS: A total of 1,011 infants with a mean TcB of 10.54 ± 3.19 (range: 2.7-19.9) mg/dL and TSB of 9.63 ± 2.61 (range: 0.3-19.5) mg/dL were assessed. Some 60 (5.9%) infants required phototherapy by 1 or more TSB criteria, with TSB ≥12 mg/dL identifying 55 (91.7%) and AAP 27 (45%) of these infants. All infants identified by the NICE and WHO criteria were equally detected by the AAP criterion. TcB showed negative predictive values of 99.0-99.9%, and positive predictive values of 7.7-15.5% across all criteria. CONCLUSIONS: The number of infants requiring phototherapy varies significantly across treatment criteria. TcB may be useful in identifying infants who do not require phototherapy, but may also identify a high proportion of false positives that is burdensome in resource-limited settings.

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.

Heliotherapy for Neonatal Hyperbilirubinemia in Southwest, Nigeria: A Baseline Pre-Intervention Study.

BACKGROUND: A novel filtered-sunlight phototherapy (FSPT) device has been demonstrated to be safe and efficacious for treating infants with neonatal jaundice in resource-constrained tropical settings. We set out to provide baseline data for evaluating the clinical impact of this device in a referral pediatric hospital. METHODS: We reviewed the medical records of infants admitted for neonatal hyperbilirubinemia in an inner-city Children's Hospital in Lagos, between January 2012 and December 2014 to determine the pattern, treatment and outcomes during the pre-intervention period. Factors associated with adverse outcomes were identified through multivariable logistic regression. RESULTS: Of the 5,229 neonatal admissions over the period, a total of 1,153 (22.1%) were admitted for neonatal hyperbilirubinemia. Complete records for 1,118 infants were available for analysis. The incidence of acute bilirubin encephalopathy (ABE) and exchange transfusion (ET) were 17.0% (95% CI: 14.9%-19.3%) and 31.5% (95% CI: 28.8%-34.3%) respectively. A total of 61 (5.5%, 95% CI: 4.3%-6.9%) of the jaundiced infants died. Weight on admission, peak total serum bilirubin (TSB), sepsis and exposure to hemolytic products were predictive of ABE, while age on admission, peak TSB, ABO incompatibility and ABE were predictive of ET. Rhesus incompatibility, asphyxia, exposure to hemolytic substances and ABE were associated with elevated mortality risk, while ET was a protective factor. Lack of routine irradiance monitoring and steady energy supply were frequent challenges for conventional blue-light phototherapy. CONCLUSIONS: Severe hyperbilirubinemia is associated with high rates of ABE and ET in this setting, and remains a significant contributor to neonatal admissions and mortality. To be impactful, FSPT, complemented with improved diagnostic facilities, should effectively curtail jaundice-related adverse outcomes in this and comparable settings.

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.).

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.