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Neonatal jaundice





                         hyperbilirubinaemia. At the threshold  value of 1.8 ppm, it showed 86% sensitivity, 80%
                         specificity, 40% PPV and 97% NPV. [EL II]

                         Evidence summary
                         ETCOc levels  were measured at  various  times  and their accuracy evaluated with  various
                         threshold values in two studies with EL II. While one study reported ETCOc to have a PPV of
                         40% and  NPV of 97%, the other study reported 13% PPV and 96%  NPV for subsequent
                         hyperbilirubinaemia.  The  second  study  also  found  no  additional  benefit  from  combining  this
                         test with pre-discharge laboratory serum bilirubin levels.

                         GDG translation from evidence
                         Although ETCOc shows good negative predictive value, it is not routinely available and does
                         not accurately predict neonatal hyperbilirubinaemia.
                         Recommendations

                         See the end of Section 4.2.
                         Umbilical cord direct antiglobulin (Coombs’) test (DAT)

                         Description of included studies
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                         One study  with EL II and four EL III studies 38-40;42  from the USA 41;42 , Norway,  Taiwan  and
                               39
                         Turkey  examining the predictive ability of the DAT have been included but no meta-analysis
                         was possible as the studies used different criteria for defining hyperbilirubinaemia.
                         Review findings
                                                    41
                         In the first study, from the USA,  universal DAT was evaluated with reference to ETCOc, and its
                         accuracy in predicting hyperbilirubinaemia was then assessed. The study population included
                         660 babies (mean gestational age 38.9 ± 1.4 weeks, mean birthweight 3267 ± 480 g) admitted
                         consecutively to the postnatal ward of a tertiary hospital. In all cases, cord blood was collected
                         and DAT was conducted by the gel test. In positive cases,  the baby was investigated for
                         haemolytic disease. The reference standard for haemolysis was ETCOc measured in all babies at
                         12 ± 6 hours and again at 24 ± 6 hours. Significant haemolysis was defined as ETCOc ≥ 95th
                         centile. Since maternal cigarette smoking was shown to influence ETCOc, measurement results
                         were given separately for babies of non-smoking and smoking mothers. Bilirubin measurement
                         (transcutaneous bilirubin in the  majority  with  subsequent serum bilirubin if required) was
                         performed in all babies at the time of hospital discharge or  earlier if clinically indicated.
                         Hyperbilirubinaemia  was  defined  as  a  bilirubin  reading  ≥ 75th  centile  on  the  Bhutani
                         nomogram.  Blinding of outcome assessors was not specified.  More than 80% of the study
                         population was black. The DAT was positive in 3.5% of babies (23 of 659). In babies of non-
                         smoking  mothers,  DAT  could  predict  haemolysis  (ETCOc  levels  ≥ 3.2 microlitre/litre)  with  a
                         sensitivity of 38.5% and specificity of 98.5%, while in babies of all mothers it showed a
                         sensitivity of 8.5% and  specificity of 97.6% in  detecting haemolysis (ETCOc levels
                         ≥ 2.5 microl/litre). The accuracy of DAT in predicting hyperbilirubinaemia was evaluated and
                         compared with that of high ETCOc levels. A positive DAT showed a sensitivity of 14.7% while
                         ETCOc showed 27.9%  sensitivity in predicting subsequent hyperbilirubinaemia in babies of
                         non-smoking mothers. The specificity of DAT compared with ETCOc was 98.2% and 97.9%,
                         respectively. [EL II]
                         The  second  study,  from  the  USA,   evaluated  selective  DAT  and  cord  blood  bilirubin
                                                         42
                         measurement  in  predicting  hyperbilirubinaemia.  The  study  population  included  91  ABO
                         incompatible  babies in a state-sponsored neonatal  programme;  Rhesus  incompatible babies
                         were excluded. Demographic information on gestational age, birthweight, gender and ethnicity
                         was not provided. Cord blood was obtained from all babies of group O mothers, and bilirubin
                         estimations were carried out at 12, 24, 36 and 48 hours of life in cases of ABO incompatibility.
                         The cord blood bilirubin threshold for a positive test was a measurement > 68 micromol/litre.
                         Babies with serum bilirubin levels > 273 micromol/litre between 12 and 36 hours were classed
                         as severely hyperbilirubinaemic. Blinding of outcome assessors  was not specified. DAT was


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