Efficacy of strategies for predicting hyperbilirubinemia NEMC Evidence Report Stanley Ip, MD Division of General Pediatrics and Adolescent Medicine The Floating Hospital for Children Tufts-New England Medical Center
Strategies evaluated • Cord Bilirubin (4 studies, n=1105) • Early Serum Bilirubin (4 studies, n=3105) • End-tidal Carbon Monoxide Concentration (2 studies, n=1421) • Predischarge Risk Index (1 study, 73 cases, 423 controls) • Predischarge Risk Zone, determined by hourspecific bilirubin percentile (1 study, n=2840)
Subjects from 12 studies • U. S. , China, Denmark, India , Israel, Japan, Spain • N: 51 to 2840 • Term only, term and preterm • Breast feeding: 4% to 90% • No Rh, but some included ABO incompatibility • Some received phototherapy
Definitions of Hyperbilirubinemia • TSB >11. 7 mg/dl, >15 mg/dl, >17 mg/dl, >25 mg/dl • TSB >16 mg/dl at 36 hours • TSB >10 mg/dl at day 2, >14 mg/dl at day 3 >17 mg/dl at day 4 and 5 • TSB ≥ 95%tile • Clinical jaundice (6. 4 mg/dl to 19. 3 mg/dl)
Cord Bilirubin Study Sensitivity Specificity Carbonell, 2001 (n=585) ≥ 2. 2 mg/dl predicts TSB ≥ 17 mg/dl day 3 to day 4 22% 95% Knudsen, 1992 (n=132) ≥ 2. 05 mg/dl predicts TSB > 11. 7 mg/dl 71% 68% Risemberg, 1977 (n=91, ABO) >4 mg/dl predicts TSB >16 mg/dl at 36 h 92% 100%
Test Performance of Cord Bilirubin Levels Adapted from Knudsen, 1992 1. 46 mg/dl 1. 75 mg/dl 2. 05 mg/dl 2. 34 mg/dl
Early Serum Bilirubin level • Awasthi, 1998 (n=274) TSB (18/24) > 3. 99 mg/dl predicts TSB>15 mg/dl; sensitivity 69%, specificity 66% • Carbonell, 2001 (n=1563) TSB(24) ≥ 6 mg/dl predicts TSB > 17 mg/dl; sensitivity 100%, specificity 45. 7% TSB (48) ≥ 9 mg/dl predicts TSB > 17 mg/dl; sensitivity 100%, specificity 64. 3% • Seidman, 1999 (n=1177) TSB (24) > 5 mg/dl is associated with 36. 5 O. R. of TSB(day 2) >10, (day 3) >14, (days 4&5) >17
Factors associated with Jaundice Multiple Logistic Analysis by Seidman, 1999 Day 1 TSB (per 1 mg/dl) ∆ in TSB from day 1 to 2 Maternal blood type O Maternal age (per year) Full breastfeeding Day 1 TSB > 5 mg/dl 3. 1 (O. R) 2. 4 2. 9 1. 1 0. 4 36. 5
Variables associated with TSB ≥ 25 mg/dl Multiple Logistic Analysis by Newman, 2000 Early jaundice FH of jaundice Exclusive Breastfeed Bruising Asian Race Cephalohematoma Maternal age ≥ 25 Lower gestational age 7. 3 (O. R. ) 6. 0 5. 7 4. 0 3. 5 3. 3 3. 1 0. 6/week
ROC of Predischarge Risk Index Source: Newman TB, 2000 RI=7 RI=10 • RI=7 RI=10 RI=15 RI=20
End-tidal Carbon Monoxide Concentration Okuyama, 2001 (N=51) ETCOc > 1. 8 ppm at 42 hours predicts TSB > 15 mg/dl sensitivity 86%, specificity 80%, PPV 40%, NPV 97%
Predischarge Risk Zone Bhutani, 1999 Infants who fulfilled inclusion criteria = 13, 003 Study subjects with at least 2 TSB’s (pre and post discharge) = 2840
Distribution of TSB values at selected study epochal periods Bhutani, 1999
Hour Specific TSB Bhutani, 1999
Predischarge Risk Zone Bhutani, 1999
Predischarge Risk Zone • ≥ 75%tile predischarge zone predicts to subsequent ≥ 95%tile; sensitivity 90. 5%, specificity 84. 7%, PPV 21. 6%, NPV 99. 5%
Racial distribution of study population Race Bhutani, 1999 41% NVS (prelim), 2001 15% Asian 4% 5% Hispanic 4% 21% White 43% 58% Other 8% 1% African-American
ROC Curves Comparing ETCOc, STB Alone, and Combined ETCOc and STB at 30± 6 hrs Stevenson, 2001
Stevenson, 2001 Study sites Study size TSB ≥ 95%tile (from Bhutani, 1999) Cleveland 353 20 (5. 7%) Hong Kong 1 303 25 (8. 3%) Stanford 194 19 (9. 8%) Hong Kong 2 167 9 (5. 4%) Jerusalem 1 119 9 (7. 6%) Providence 116 10 (8. 6%) Philadelphia 50 8 (16. 0%) Jerusalem 2 37 8 (21. 6%) Kobe 31 12 (38. 7%) Total 1370 120 (8. 8%)
Summary • Not possible to directly compare the accuracy of various strategies • Higher TSB at an early age is associated with hyperbilirubinemia • Hour-specific nomogram method appears promising (AUC 0. 93) but further validation is needed
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