Evaluation of transcutaneous bilirubinometer (DRAEGER JM 103) use in Zimbabwean newborn babies

Abstract

Background

Acute Bilirubin Encephalopathy in the neonatal period is a major cause of permanent disability. Effective screening and surveillance are essential in the newborn period to enable timely management. Noninvasive transcutaneous bilirubin devices have been successfully used for screening in many settings. We evaluated the accuracy of the Draeger JM 103 (Medical Systems, USA) for estimating serum bilirubin in Zimbabwean newborns.

Methods

Paired transcutaneous (forehead and sternum) and serum bilirubin measurements were compared on 283 infants consecutively recruited between 01 August and 30 November 2015 at Harare Hospital Neonatal Unit. Using serum bilirubin as gold standard, Pearson Correlation Coefficient (r) was calculated for the two transcutaneous measurement sites. Linear regression plots of transcutaneous versus serum estimates were performed. Comparison was made between preterm and term babies. Specificity, sensitivity, positive predictive value and negative predictive value of the JM103 were calculated including ROC curves to assess the accuracy of the diagnostic tests.

Results

Fifty-five percent of the babies were male. Median gestational age was 38 weeks (range 28–42). One hundred and fifteen (41%) were preterm. Median postnatal age was 3 days (range 0–10). Serum bilirubin ranged 85–408 μmol/l, transcutaneous bilirubin sternum; 170–544 μmol/l and forehead; 119–510 μmol/l. Correlation between serum and transcutaneous bilirubin (sternum) was 0.77 and between serum and transcutaneous (forehead) was 0.72. Preterm babies correlation for sternum was 0.77 and forehead was 0.75. Term babies correlation for sternum was 0.76 and forehead was 0.70. The sensitivity for the sternum site was 76%, specificity 90%, Positive Predictive Value of 70 and Negative Predictive Value 92. Sensitivity for forehead site was 62%, specificity 95% with a Positive Predictive Value of 80 and Negative Predictive Value of 90. Bland-Altman plot of serum versus transcutaneous measurements showed agreement between the tests. The ROC curves showed that the accuracy of the two diagnostic tests were good with no significant difference between the two, p = 0.2954.

Conclusion

The study demonstrated a strong positive correlation for both sternum and forehead sites with serum bilirubin in this Zimbabwean population of African origin. However, the sternum is a better site for identifying babies with jaundice compared to forehead. The Draeger JM-103 can be used to screening for neonatal jaundice in this population.