Page 253 - 16Neonatal Jaundice_compressed

Appendix H: Evidence tables

Bibliographic details Study type & Patient characteristics Test, Reference Standard, Results Reviewers Comments
Evidence level Threshold for a positive test
Diagnostic determined by best obstetric estimate 1. End-tidal CO measurement 6 hours and 96 + 12 hours
Year: 2001 study/cohort and enrolled serially from 9 clinical corrected for inhaled CO (ETCOc) 120/1370 (8.8%) Baseline data presented for
sites (4 domestic and 5 international) at 30 ± 6 hours (threshold value: total group
Country: USA Evidence Level: II within the first 36 hours of life. value > population mean) Comparison of ETCOc levels between
(1370 (72.3%) completed the
32 n = 1895 Group 1 vs Group 2 (mean ± SD) study)
Mean BW: Not reported 2. TSB at 30 ± 6 hours (threshold 1.45 ± 0.47 ppm vs 1.81 ± 0.59 ppm (P
th
Mean GA: Not reported value: TSB = 75 centile) Test & Reference test described
Gender: Males = 49% < 0.001) in detail
Ethnicity: Timing of various TSB Diagnostic accuracy of ETCOc, TSB and Reference test a standard one
Asian/Pacific Islander = 38.9% measurements: combined test in predicting Blinding – Not reported
White = 33.1% Data not given for calculating
Black = 16.4% a) at 30 ± 6 hours for all babies hyperbilirubinaemia - derived from ROC TP, FP, FN, and TN.
Hispanic = 3.9% (Test) curves - (at 30 ± 6 hours) Confounding factors adjusted
Other = 7.7% b) between 24 - 84 hours only on for during modelling
clinical grounds ETCOc (threshold > population mean)
Exclusion: c) at 96 ± 12 hours for all babies Sensitivity: 92/120 (76.7%)
babies requiring admission to NICU, d) till 168 hours as per study Specificity: 635/1250 (50.8%)
severe congenital anomalies, protocol PPV: 92/707 (13.0%)
babies in incubators, NPV: 635/663 (95.8%)
pulmonary disease requiring oxygen
or any form of ventilatory support, Reference standard: Lab TSB TSB (threshold > 75 centile) after
th
with BW < 850 g, confirmed hyperbilirubinaemia th
and respiratory rates = 10 or = 100 excluding babies with TSB > 95 centile at
breaths/min. Hyperbilirubinaemia was defined < 36 hours
th PPV: 16.7%
th
Babies with age-specific TSB = 95 as Age-specific lab TSB = 95 NPV: 98.1%

centile
centile either at < 24 hours, at Combined test
30 ± 6 hours, at 24–84 hours or at PPV: 6.4%
Analysis: NPV: 99.0%
96 ± 12 hours exited the study after Logistic regression analysis models
giving test samples. performed for prediction of
th
Also babies with TSB < 40 centile hyperbilirubinaemia with ETCOc
at 96 ± 12 hours exited. and TSB at 30 ± 6 hours using
multiple variables (bruising, type of
feeding, BW, race, maternal
diabetes, type of labor, gender,
infection, PIH, parity, maternal
blood type and Rh status)

Okuyama H; Study Type: Full-term infants with GA = 37 weeks Test: Group 1 vs Group 2 Unselected population but
Diagnostic study and BW = 2500 g. End-tidal CO measurement No statistical differences between the two small sample size
Year: 2001 corrected for inhaled CO (ETCOc) groups for sex, GA, mode of delivery,
Evidence Level: II n = 51 every 6 hours during the first Apgar score at 1 min, age at peak TcB, and Test & Reference test described
Country: mean BW 3108 ± 327 g, mean GA 72 hours. (different threshold feeding type. adequately
Japan values at different age) Reference test a standard test

199