Neonatal hyperbilirubinaemia: a global perspective.

Background: Each year an estimated 2.6 million newborns die, mainly from complications of prematurity, neonatal infections, and intrapartum events. Reducing these deaths requires high coverage of good quality care at birth, and inpatient care for small and sick newborns. In low- and middle-income countries, standardised measurement of the readiness of facilities to provide emergency obstetric care has improved tracking of readiness to provide care at birth in recent years. However, the focus has been mainly on obstetric care; service readiness for providing inpatient care of small and sick newborns is still not consistently measured or tracked. Methods: We reviewed existing international guidelines and resources to create a matrix of the structural characteristics (infrastructure, equipment, drugs, providers and guidelines) for service readiness to deliver a package of inpatient care interventions for small and sick newborns. To identify gaps in existing measurement systems, we reviewed three multi-country health facility survey tools (the Service Availability and Readiness Assessment, the Service Provision Assessment and the Emergency Obstetric and Newborn Care Assessment) against our service readiness matrix. Findings: For service readiness to provide inpatient care for small and sick newborns, our matrix detailed over 600 structural characteristics. Our review of the SPA, the SARA and the EmONC assessment tools identified several measurement omissions to capture information on key intervention areas, such as thermoregulation, feeding and respiratory support, treatment of specific complications (seizures, jaundice), and screening and follow up services, as well as specialised staff and service infrastructure. Conclusions: Our review delineates the required inputs to ensure readiness to provide inpatient care for small and sick newborns. Based on these findings, we detail where questions need to be added to existing tools and describe how measurement systems can be adapted to reflect small and sick newborns interventions. Such work can inform investments in health systems to end preventable newborn death and disability as part of the Every Newborn Action Plan.

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Service readiness for inpatient care of small and sick newborns: what do we need and what can we measure now?

BACKGROUND: Severe neonatal hyperbilirubinemia (>20 mg/dL) affects ∼1 million infants annually. Improved jaundice screening in low-income countries is needed to prevent bilirubin encephalopathy and mortality. METHODS: The Bili-ruler is an icterometer for the assessment of neonatal jaundice that was designed by using advanced digital color processing. A total of 790 newborns were enrolled in a validation study at Brigham and Women’s Hospital (Boston) and Sylhet Osmani Medical College Hospital (Sylhet, Bangladesh). Independent Bili-ruler measurements were made and compared with reference standard transcutaneous bilirubin (TcB) and total serum bilirubin (TSB) concentrations. RESULTS: Bili-ruler scores on the nose were correlated with TcB and TSB levels (r = 0.76 and 0.78, respectively). The Bili-ruler distinguished different clinical thresholds of hyperbilirubinemia, defined by TcB, with high sensitivity and specificity (score ≥3.5: 90.1% [95% confidence interval (CI): 84.8%–95.4%] and 85.9% [95% CI: 83.2%–88.6%], respectively, for TcB ≥13 mg/dL). The Bili-ruler also performed reasonably well compared to TSB (score ≥3.5: sensitivity 84.5% [95% CI: 79.1%–90.3%] and specificity 83.2% [95% CI: 76.1%–90.3%] for TSB ≥11 mg/dL). Areas under the receiver operating characteristic curve for identifying TcB ≥11, ≥13, and ≥15 were 0.92, 0.93, and 0.94, respectively, and 0.90, 0.87, and 0.86 for identifying TSB ≥11, ≥13, and ≥15. Interrater reliability was high; 97% of scores by independent readers fell within 1 score of one another (N = 88). CONCLUSIONS: The Bili-ruler is a low-cost, noninvasive tool with high diagnostic accuracy for neonatal jaundice screening. This device may be used to improve referrals from community or peripheral health centers to higher-level facilities with capacity for bilirubin testing and/or phototherapy.

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A novel icterometer for hyperbilirubinemia screening in low-resource settings

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.

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

Background: The ability of mothers to correctly detect jaundice in their newborns is largely unknown. The objective was to ascertain the ability of mother to correctly detect the presence of significant jaundice in her newborn. Materials and Methods: This cross-sectional study was conducted in a tertiary care hospital in eastern India from February 2015 to July 2016. All inborn neonates more than 34 weeks' gestation were included. Congenital malformations, perinatal asphyxia, neonatal sepsis, readmission after discharge, and isoimmunization were excluded. A total of 505 inborn newborns were independently assessed by the mother and the treating pediatrician for significant jaundice every day till discharge. Each newborn underwent total serum bilirubin estimation on suspicion of significant jaundice by either of the two or at discharge, whichever was earlier. Results: The sensitivity, specificity, positive predictive value (PPV), and negative predictive value of maternal detection of significant jaundice was 51.47%, 88.33%, 39.29%, and 92.12%, respectively. Conclusion: Mothers have poor sensitivity and PPV to detect significant neonatal jaundice in the Indian population.

Maternal ability to correctly detect significant jaundice in Indian neonates

Aim

To determine whether home-use icterometry improves parental recognition of neonatal jaundice, early care seeking and treatment to minimize risks of bilirubin encephalopathy.



Methods

Cluster-randomised controlled trial of community-level icterometry used at home by mothers in Chi Linh, Vietnam. Rural health-care workers identified and enrolled term newborns. Post-partum mothers received jaundice education and icterometry instructions and were cluster-randomised by commune. Cases received icterometers (icterometer group (IG)) and controls did not (control group (CG)). Subjects received mobile telephone calls from post-natal days 2–7 to determine maternal recognition by visual inspection and icterometer detection of jaundice (≥3.0 on five-point scale). Mothers without telephones, premature newborns ( 5 days were excluded.



Results

Three hundred fifty-two subjects were enrolled (183 IG and 169 CG), of whom 11 (3.4%) were lost to telephone follow-up. Jaundice was recognised and/or detected in 94 (27%) of all newborns. Icterometry helped 11 mothers (6%) detect neonatal jaundice that was not visually recognised by IG mothers. Detection by IG mothers was not statistically greater than CG mothers (P = 0.09). Follow-up care seeking was 8% in both groups (P = 0.2), and 11% of jaundiced newborns received treatment (9% IG vs. 16% CG, P = 0.3). Newborns who received care had bilirubin measurements that averaged 257 μmol/L IG vs. 322 μmol/L CG (P = 0.3). There were no deaths.



Conclusions

In this pilot study, home-use icterometry may help improve parental detection of jaundice in rural Vietnam. However, larger studies are necessary to determine the changes in recognition, care seeking and treatment.

Mitchell N Luu

Papers

Home-use icterometry in neonatal hyperbilirubinaemia: Cluster-randomised controlled trial in Vietnam.