Transcutaneous bilirubin nomogram for the first 144 hours in Thai neonates.

Objectives: To develop an hour-specific transcutaneous bilirubin (TcB) nomogram for Thai neonates and to compare the ability of this nomogram with that of Bhutani's total serum bilirubin (TSB) nomogram for prediction of significant hyperbilirubinemia requiring phototherapy.Methods: Healthy Thai neonates, gestational age ≥35-week-gestation and birth weight ≥2000 grams were enrolled. Neonates who could not attend the postdischarge follow-up at our center were excluded. TcB measurements were routinely performed at 6 am and 6 pm using JM103 transcutaneous bilirubinometer until the neonates were discharged or received phototherapy. TcB levels were also measured at least once during 24-72 hours after discharge and thereafter depending on the pediatricians' decision. The nomogram was developed from the TcB data during age 12-144 hours of neonates who did not require phototherapy. The TcB values that obtained predischarge or before receiving phototherapy of all neonates were used to determine the predictive ability of this nomogram and Bhutani's TSB nomogram.Results: A total of 1071 neonates were included. Two hundred forty-one neonates (22.5%) required phototherapy. The nomogram was constructed using 4834 hour-specific TcB values. It provided a good prediction with the area under curve (AUC) of 0.89. The 75th percentile tract revealed sensitivity and negative predictive value (NPV) of 87.1 and 95.4% while that of the 40th percentile tract were 97.9 and 98.5% respectively. When Bhutani's nomogram was used, the AUC was 0.84. The sensitivity and NPV of the 75th percentile tract were 56.4 and 88.2%, and for the 40th percentile tract were 97.1 and 98.0% respectively.Conclusion: The newly developed TcB nomogram revealed slightly better predictive ability than Bhutani's TSB nomogram for term and late preterm Thai neonates who were the population with high prevalence of significant hyperbilirubinemia. The 40th percentile curve of both nomograms should be considered as an appropriate cut-off level for prediction.

Accuracy of the Bilicare™ transcutaneous bilirubinometer as the predischarge screening tool for significant hyperbilirubinemia in healthy term and late preterm neonates.

Background: The Bilicare™ is a new device that measures transcutaneous bilirubin (TcB) level at the ear pinna. There are only few studies which have evaluated its accuracy in clinical practice.Objective: This study aims to determine the accuracy of Bilicare™ as a predischarge screening tool in late preterm and term neonates and to define the optimal cutoff point for determining the need to measure total serum bilirubin (TSB).Methods: The 35 weeks' gestation or more and healthy neonates who underwent predischarge TSB measurement were enrolled. Bilicare™ TcB was measured within 30 minutes of blood sampling. Paired TcB and TSB data were analyzed.Results: We collected 214 paired samples. Mean age (SD) at TcB measurement was 57.17 (7.47) hours. Mean TSB (SD) was 9.79 (2.83) mg/dL. TcB showed a significant correlation with TSB (r = 0.84, r2 = 0.7). The mean difference (SD) between TcB and TSB was 0.7 (0.21) mg/dL (95%CI 0.49-0.91). TcB tended to overestimate TSB level at the TSB values of <12 mg/dL but underestimate at the higher TSB level. The accuracy of using TcB values to detect neonates who required phototherapy was 92.5%. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 78.3, 94.2, 62.1, and 97.3%, respectively. If TcB +3 mg/dL was applied as a cutoff point, the sensitivity, specificity, PPV, and NPV were 100, 53.9, 20.7, and 100%, respectively.Conclusions: Bilicare™ TcB and TSB measurements were well correlated. The TcB level +3 mg/dL could detect all neonates who had significant hyperbilirubinemia requiring phototherapy during their birth hospitalization.

Health professionals' views of newborn pulse oximetry screening in a midwifery-led maternity setting. "It's a good thing to do, but fund it!"

OBJECTIVE: To understand from health professionals who care for newborns their views on the introduction of pulse oximetry screening for the detection of hypoxaemia in a midwifery-led maternity setting. Although oximetry screening for newborns is internationally accepted, national screening is not yet introduced in New Zealand. In this context, we drew on maternity carers' reflections during a feasibility study of oximetry screening to provide perspectives on barriers and enablers to universal screening. METHODS: Data were generated from nine focus groups during five months of 2018 in two north island regions of New Zealand. Participants' (n = 45) opinions about the use of oximetry screening in newborns were analysed thematically using an inductive approach. FINDINGS: Overall, participants stated pulse oximetry screening was easy to do, non-invasive, and worthwhile. Midwives were reassured by screening that provided evidence of either a healthy baby or a need for urgent review. From participants' reports, we identified three themes: (1) oximetry screening for newborns is reassuring, practical and worthwhile; (2) midwifery services workload expectations and under-resourcing will hinder universal screening, and (3) location of the baby at the time of screening could impede universal access. CONCLUSION AND IMPLICATIONS FOR PRACTICE: Midwives viewed implementing a national pulse oximetry screening programme as sensible but problematic unless resourced and funded appropriately. Policymakers should view the concerns of midwives about human and physical resources as significant and account for the need to resource this screening programme appropriately as a priority before implementation.

A Novel Icterometer for Hyperbilirubinemia Screening in Low-Resource Settings.

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.

Transcutaneous bilirubinometer use and practices surrounding jaundice in 150 California newborn intensive care units.

OBJECTIVES: Transcutaneous bilirubin measurements (TcBs) provide a noninvasive method for screening infants for hyperbilirubinemia and have been used extensively in term and late preterm newborns in well baby nurseries, offices, and outpatient clinics. Several studies have also demonstrated the utility of TcBs as a screening tool for infants > 28 weeks' gestation and their ability to reduce the need for blood sampling. The objectives of this study are to identify how often TcBs are used among California Newborn Intensive Care Units (NICUs) in preterm, late preterm and term infants, and other aspects of jaundice management. METHODS: We conducted a survey on TcB use and practices relating to jaundice management in 150 California NICUs between April and October 2016. RESULTS: TcB screening is routinely used in 28% (42/150) of NICUs. Only 7% (11/150) of NICUs use TcB in preterm infants < 28 weeks. Practice varied similarly across NICU levels of care. Among the subset of NICUs that responded to questions related to phototherapy and screening practices, prophylactic phototherapy was used in 38% (23/59) and 90% (55/61) screened for glucose-6-phosphate dehydrogenase deficiency based on race, ethnicity, and/or family history. CONCLUSION(S): Despite studies validating the accuracy of TcB in preterm infants > 28 weeks, only 28% of California NICUs routinely use TcB devices. TcB screening in infants < 28 weeks gestation is not widely used and no recommendation can be made in this regard until there is more experience with its application using a standardized protocol in these infants and on a large scale.

Neonate auditory brainstem response repeatability with controlled force gauge bone-conducted stimulus delivery.

OBJECTIVE: The feasibility and repeatability of neonate auditory brainstem responses (ABRs) with a controlled hand-held applied force gauge for bone-conducted stimulus delivery was examined. DESIGN: A repeated measures test-retest design was employed. STUDY SAMPLE: Participants were 27 healthy neonates. A 4000 Hz bone-conducted CE-Chirp octave band stimulus evoked the ABRs. Intra- and intertester conditions were employed with a prototype hand-held applied force gauge (Etymotic Research) attached to the superior aspect of the bone vibrator. The bone vibrator was placed in a superoposterior auricular position and held manually. The force gauge displayed a desired coupling force via an LED light indicator. RESULTS: Three sets of replicated ABRs were recorded from all neonates: initial test and retest with one tester (i.e. intratester 1 and 2) and final test with a second tester (i.e. intertester). No significant differences in intra- or intertester ABR wave V latencies or amplitudes were found (p > 0.05). Coefficients of reliability (Cronbach's α) were .95 and .43 for wave V latencies and amplitudes, respectively. CONCLUSIONS: A hand-held applied force gauge may be a reliable means of delivering controlled bone-conducted stimuli in ABR assessments in neonates and infants.

Clinical utility of transcutaneous bilirubinometer (TcB) in very low birth weight (VLBW) infants.

OBJECTIVE: This is a comprehensive study designed to evaluate the clinical usefulness of transcutaneous bilirubinometry (TcB) in very low birth weight (VLBW) newborns of African American (AA) descent. METHODS: TcB was conducted at the anterior superior iliac spine (ASIS), temporal region and sternum within 2 h of total serum bilirubin (TSB) measurements in newborns born at ≤32 weeks' gestation prospectively. Average (AVG) TcB levels were also calculated. The relationships between TSB and TcB levels were analyzed using non-parametric Spearman bivariate correlations, a Bland-Altman plot procedure and a decision tree (DT) analysis. RESULTS: One hundred newborns and 555 TSB data points were available. Eighty-nine percent of the newborns were AA. A significant correlation (P<0.0001) was observed between TSB and TcB values obtained at the ASIS (r=0.73), sternum (0.73), temporal region (0.61) and AVG (0.77). The Bland-Altman plot revealed a good agreement between AVG TcB values and TSB values. A DT analysis indicated that AVG TcB was also found to be the most significant predictor of TSB values in both the no phototherapy (PT) and biliblanket subgroups. CONCLUSION: TcB can be used reliably in VLBW AA newborns in the absence of overhead PT. The use of TcB in monitoring jaundice in VLBW newborns would help decrease the number of blood draws and cost of care.

Effect of Phototherapy on the Reliability of Transcutaneous Bilirubin Devices in Term and Near-Term Infants: A Systematic Review and Meta-Analysis.

BACKGROUND: Transcutaneous bilirubin (TcB) devices are commonly used for screening of hyperbilirubinemia in term and near-term infants not exposed to phototherapy. However, the accuracy of TcB devices in infants exposed to phototherapy is unclear. OBJECTIVES: To conduct a systematic review of studies comparing TcB devices with total serum bilirubin (TSB) in infants receiving phototherapy or in the postphototherapy phase. METHODS: MEDLINE, EMBASE, Cochrane Library, CINAHL and Scopus databases (from inception to May 8, 2014) were searched. Additional citations were identified from the bibliography of selected articles and from the abstracts of conference proceedings. The studies were included if they compared TcB results with TSB in term and near-term infants during phototherapy or after discontinuation of phototherapy. Two reviewers independently assessed studies for inclusion, and discrepancies were resolved with consensus. Risk of bias was assessed using the QUADAS-2 tool. RESULTS: Fourteen studies were identified. The pooled estimates of correlation coefficients (r) during phototherapy were: covered sites 0.71 (95% CI 0.64-0.77, 11 studies), uncovered sites 0.65 (95% CI 0.55-0.74), 8 studies), forehead 0.70 (95% CI 0.64-0.75, 12 studies) and sternum 0.64 (95% CI 0.43-0.77, 5 studies). Two studies also provided results as Bland-Altman difference plots (mean TcB-TSB differences -29.2 and 30 µmol/l, respectively). The correlation coefficient improved marginally in the postphototherapy phase (r = 0.72, 95% CI 0.64-0.78, 4 studies). CONCLUSION: We found a moderate correlation between TcB and TSB during phototherapy with a marginal improvement in the postphototherapy phase. Further research is needed before the use of TcB devices can be recommended for these settings.

Comparison of the transcutaneous bilirubinometers BiliCare and Minolta JM-103 in late preterm and term neonates.

OBJECTIVES: To assess the agreement of transcutaneous bilirubin (TcB) measurement with the Bilicare™ System in comparison to TcB measured with JM-103™ and total serum bilirubin (TSB). METHODS: Caucasian infants with gestational age ≥35 weeks with non-hemolytic jaundice received TcB measurement with both Bilicare™ and JM-103™ devices. TSB was also obtained in infants at risk of phototherapy. RESULTS: We studied 458 infants measuring TcB with Bilicare™ and JM-103™, correlating the results and with TSB. The mean difference ± 2SD between Bilicare™ and JM-103™ TcB was 2.02 ± 4.46 mg/dL and decreased from 2.88 ± 3.17 to 1.20 ± 4.55, and to -0.95 ± 4.58 mg/dL at mild, moderate and high TcB values, respectively. CONCLUSIONS: Bilicare™ and JM-103™ TcB measurements are well correlated, but Bilicare™ over-estimates TcB for mild and moderate values and under-estimates it for high values compared to JM-103™. This could increase the prescription of TSB measurements for less serious cases and decrease them in the most worrisome.

Predictive value of cord blood bilirubin for hyperbilirubinemia in neonates at risk for maternal-fetal blood group incompatibility and hemolytic disease of the newborn.

OBJECTIVE: To determine the predictive ability of cord blood bilirubin (CBB) for hyperbilirubinemia in a population at risk for maternal-fetal blood group incompatibility and hemolytic disease of the newborn. STUDY DESIGN: This is a single center retrospective case-control study. Cases received phototherapy; controls did not. Cases were matched 1:3 to controls by gender and treating physician. Inclusion criteria included: ≥35 weeks gestation, CBB, and one or more total serum bilirubin (TSB) concentrations. The primary outcome was CBB. Secondary outcomes were a TSB >75th percentile, length of stay, and neonatal intensive care unit admission. The prognostic ability of CBB for phototherapy and TSB >75th percentile was assessed using area under the receiver operating characteristic (ROC) curve. Logistic regression analyses were performed to determine predictors for phototherapy and TSB >75th percentile. RESULT: When compared to controls (n = 142), cases (n = 54) were more likely to have a positive Coombs' test (82% vs. 41% , p <  0.001) and TSB >75th percentile (85% vs. 21% , p <  0.001). When compared to controls, cases had a higher mean (±SD) CBB (2.5 ± 0.5 vs. 1.8 ± 0.4 mg/dL, p <  0.001). The area under the ROC curve (±SEM) for CBB for phototherapy and TSB >75th percentile was 0.87 ± 0.03 (p <  0.001, 95% CI 0.82, 0.93) and 0.87 ± 0.03 (p <  0.001, 95% CI 0.82, 0.92), respectively. CONCLUSION: In this study, the mean CBB concentration was higher in neonates who received phototherapy compared to those who did not. CBB concentrations may help predict severe hyperbilirubinemia and phototherapy in a population at risk for hemolytic disease of the newborn.

Transcutaneous bilirubin levels in newborns <35 weeks' gestation.

OBJECTIVE: In infants <35 weeks' gestation, we sought to define the transcutaneous bilirubin (TcB) levels at which a total serum bilirubin (TSB) level suggesting the need for phototherapy is unlikely to occur and a TSB measurement can, therefore, be avoided. STUDY DESIGN: Nursing staff performed 896 TcB measurements within 1 h of a TSB on 225 neonates 26 0/7-34 6/7 weeks' postmenstrual age (PMA). Generalized linear models were fit with generalized estimating equations (GEEs) to model the probability of having a TSB level at or above the phototherapy initiation cutpoint as a function of the TcB; these methods allow for multiple tests per infant. RESULTS: The mean difference between TcB and TSB measurements was <1 mg dl(-1) for each PMA category. When the TcB was at least 3 mg dl(-1) below the TSB cutpoint for phototherapy, there was a ⩾98% probability that the TSB was not at, or above, the recommended phototherapy level. The single exception to this was a phototherapy level of 6 mg dl(-1) for infants of 28 0/7-29 6/7 weeks' PMA, where a TcB of 4 mg dl(-1) below the phototherapy level (ie a TcB ⩽2 mg dl(-1)) was necessary to achieve ⩾98% probability. CONCLUSION: Our data support the use of routine TcB screening for infants 28-34 6/7 weeks' gestation. TcB screening in the neonatal intensive care unit can identify infants who require a TSB to confirm or exclude the need for phototherapy.

Can transcutaneous bilirubinometry safely guide phototherapy treatment of neonatal jaundice in Malawi?

OBJECTIVES: To assess the correlation between total serum bilirubin (TSB) and transcutaneous bilirubin (TcB) values in Malawian newborn infants, and to investigate whether TcB can be used safely to guide phototherapy treatment in the absence of TSB results. METHODS: 128 newborn jaundiced infants were studied in the neonatal nursery at Queen Elizabeth Central Hospital, Blantyre. Paired TSB and TcB measurements (from forehead and sternum) were compared using the linear regression and Bland-Altman methods. Clinical decisions based on TcB results were compared with those based on 'gold standard' TSB results. RESULTS: For infants not under phototherapy, the lowest TcB reading (from forehead or sternum) gave the strongest correlation with TSB: r = 0·83 for term infants and r = 0·71 for premature infants. For infants undergoing phototherapy, the highest TcB reading gave the strongest correlation with TSB: r = 0·66 for term infants and r = 0·71 for premature infants. TcB values overestimated the degree of jaundice. For infants not under phototherapy, the mean (SD) bias and imprecision of TcB was 25 (72) µmol/L for term infants and 37 (73) µmol/L for premature infants. For infants under phototherapy, the mean bias and imprecision was 30 (79) µmol/L for term infants and 44 (77) µmol/L for premature infants. For infants not under phototherapy, using the lowest TcB reading to guide treatment decisions (n = 167) had good sensitivity (91%) and specificity (90%). For infants undergoing phototherapy, using the highest TcB reading to guide treatment decisions (n = 129) had good sensitivity (94%), but lower specificity (36%). CONCLUSIONS: TcB can be used to safely guide phototherapy treatment in a resource-poor setting.

Reliability of transcutaneous bilirubin devices in preterm infants: a systematic review.

BACKGROUND AND OBJECTIVE: Transcutaneous bilirubin (TcB) devices are widely used for the estimation of serum bilirubin levels in term and near-term infants. Our objective was to review the diagnostic accuracy of TcB devices in preterm infants. METHODS: Medline, Embase, Cochrane library, Cumulative Index to Nursing and Allied Health Literature, and Scopus were searched (from database inception date until December 2012). Additional citations were identified by using the bibliographies of selected articles and from conference proceedings. The studies were included if they compared TcB with total serum bilirubin in preterm infants before phototherapy and presented data as correlation coefficients or as Bland-Altman difference plots. Data were extracted by 1 reviewer and checked for accuracy by the second reviewer. An assessment tool (quality assessment of diagnostic accuracy studies) was used for risk of bias assessments. RESULTS: Twenty-two studies met the inclusion criteria; 21 studies reported results as correlation coefficients, with pooled estimates of r = 0.83 for each site of measurement. Pooled estimates in infants <32 weeks' gestation were similar to the overall preterm population (r = 0.89 [95% confidence interval: 0.82-0.93]). For the 2 commonly used TcB devices (ie, JM103 and BiliCheck), the results were comparable at the forehead site, although the JM103 device exhibited better correlation at the sternum. Analysis of the Bland-Altman plots (13 studies) revealed negligible bias in measurement at the forehead or sternum site by using either the JM-103 or BiliCheck device; however, the JM-103 device exhibited better precision than the BiliCheck (SD for TcB - total serum bilirubin differences: 24.3 and 31.98 µmol/L, respectively). CONCLUSIONS: The TcB devices reliably estimated bilirubin levels in preterm infants and could be used in clinical practice to reduce blood sampling.

ABR in newborns: effects of electrode configuration, stimulus rate, and EEG rejection levels on test efficiency.

OBJECTIVE: This study investigated the effect of electrode configuration, stimulus rate, and EEG rejection level on the efficiency of ABR testing in babies. DESIGN: ABR to click stimuli at 40 dB nHL were simultaneously recorded from two electrode configurations, ipsilateral mastoid to high forehead (Mi-Fh) and nape to high forehead (N-Fh), with two EEG rejection levels (± 5 µV and ± 10 µV). Stimulus rates were between 39.1 and 69.1 per second. Efficiency was measured by confidence in the ABR for a given test time. STUDY SAMPLE: Thirty babies who had passed a targeted newborn hearing screen with ABR thresholds ≤ 40 dB nHL. RESULTS: The N-Fh configuration, as expected, gave on average a larger response amplitude compared to the Mi-Fh configuration but was only marginally significantly better in terms of test efficiency. There was no significant effect of stimulus rate on test efficiency between 39.1/s and 59.1/s. The lower ± 5 µV EEG rejection level was more test efficient. CONCLUSIONS: This study provides some evidence that, for ABR threshold testing in babies, alternatives of ipsilateral mastoid or nape electrode and a range of stimulus rates have little or no effect on test efficiency. The results support the use of low EEG rejection limits.

BiliCheck vs JM-103 in identifying neonates not at risk of hyperbilirubinaemia.

BACKGROUND: Transcutaneous bilirubinometry is widely used to predict hyperbilirubinemia by using several devices. The aim of this study was to compare the predictive ability of BiliCheck vs JM-103 in identifying neonates not at risk of significant hyperbilirubinemia, putting the data obtained with the two instruments on our transcutaneous bilirubin nomogram built with the BiliCheck. METHODS: Transcutaneous bilirubin (TcB) measurement was performed when jaundice appeared in newborn babies and/or just before discharge from the hospital. It was performed at the forehead with the two instruments within 5 minutes by two experienced neonatologists, each one blind to the value obtained by the other. Blood samples were drawn to obtain total serum bilirubin (TSB) levels soon after TcB measurements. RESULTS: A total of 627 paired-sample measurements were obtained from 298 newborn babies. Out of the total population studied, 16 newborn babies (5.4%) showed significant hyperbilirubinemia defined as TSB value >17 mg/dL, or as need for phototherapy treatment according to the AAP guidelines. TcB measurements showed false negative results in the first 60 hours of life using both devices. After the 60th hour of life, TcB measurements using both devices successfully predicted newborn babies not at risk of significant hyperbilirubinemia, being the JM-103 more reliable than BC because of fewer false positive results. CONCLUSIONS: Our study shows that both BC and JM-103 can exclude subsequent significant hyperbilirubinemia when the measurements are performed after the 60th hour of life. Nevertheless, the transcutaneous pre-discharge screening should be considered only as the first step, and it has to be followed by a follow-up through the first days after discharge.

How to use: transcutaneous bilirubinometry.

The National Institute for Health and Clinical Excellence neonatal jaundice guidelines recommend checking the bilirubin level in all infants with visible jaundice. The gold standard for this measurement is total serum bilirubin (TSB). Transcutaneous bilirubinometry (TcB) is an alternative to TSB that has been validated for clinical use through extensive study. TcB provides many advantages over TSB including instantaneous measurements without requiring a painful lab draw. For infants >35 weeks gestation, TcB can reliably identify infants at risk for severe hyperbilirubinaemia and can decrease the number of TSB measurements obtained. However, paediatric providers should be aware of limitations in clinical use of TcB including decreasing accuracy at higher bilirubin levels, lack of independently validated nomograms for interpretation and limited research regarding its use during phototherapy.

Comparison of the transcutaneous bilirubinometers BiliCheck and Minolta JM-103 in preterm neonates.

AIM: To investigate the trueness and uncertainty of two transcutaneous bilirubinometers BiliCheck and Minolta JM-103 in preterm infants; establish cut-off values for the transcutaneous bilirubin (TcB) level, indicating the need for total serum bilirubin (TsB) measurement; and estimate how many blood samples could be saved. METHODS: In 133 neonates with gestational ages 28(+0) -34(+6) weeks, 239 measurements of TcB by BiliCheck (TcB(B)) and JM-103 (TcB(M)) and of TsB were performed. RESULTS: Median TsB of the first samples was 160 (range, 53-293) µmol/L, whereas median TcB(B) was 12 µmol/L (8%) lower and TcB(M) 67 µmol/L (40%) lower. TcB(B) underestimated TsB for TsB ≥180µmol/L. All TcB(M) values, except one, underestimated TsB. The underestimation increased with increasing TsB. Multiple regression analysis showed that post-natal age and ethnicity were confounding factors for TcB(M); none were found for TcB(B). The uncertainty was the same for the two instruments. By using cut-off values of 70% of the phototherapy limit for TcB(B) and 35% for TcB(M), the sensitivity of the screening would be 95% and 97%, and 36% and 24% of the blood samples could be saved, respectively. CONCLUSION: TcB determined with JM-103 gave values much lower than those obtained with BiliCheck. The underestimation of TsB increased with increasing concentrations. By using transcutaneous bilirubinometers in preterm neonates, 24-36% of the blood samples could be saved.

ABR-based newborn hearing screening with MB11 BERAphone® using an optimized chirp for acoustical stimulation.

OBJECTIVE: At our center, the Maico MB11 BERAphone(®) device is used for newborn hearing screening based on Auditory Brainstem Responses (ABR). In 2006, an optimized chirp stimulus was implemented in the device to increase the reliability and quality of the screening method. In 2002, an automated response detection algorithm had been implemented. This study analyzes the screening results using the MB11 BERAphone(®) device with the implemented chirp stimulus and automated response detection method. METHODS: The data presented were collected in the well-baby nursery as part of the newborn hearing screening program following a two stage screening protocol. To focus the study on the typical routine screening, data from at-risk babies were not included. Overall, data from 6866 babies (3604 males and 3262 females) screened from March 2006 to April 2011 were analyzed in this study. RESULTS: Out of the 6866 babies screened, 6607 passed bilaterally prior to hospital discharge (defined as 1st stage in this hearing screening program). Therefore, the pre-discharge pass rate of the hearing screening with the MB11 BERAphone(®) device was 96.2%. The resulting referral rate was 3.8%. The median test time per ear (excluding time for preparation and data reporting) was 28s with a range of 15-112s (5-95th percentile). The number of infants referred for 2nd stage, post-discharge re-screening was 259. Of this group, 71 passed bilaterally and 188 failed the re-screening in one or both ears. Therefore, including both the pre-discharge and post-discharge screening results, the bilateral pass rate was 97.3% and 2.7% were referred for diagnostic evaluation. Diagnostic testing was performed on all of the 188 infants who were referred. Results showed that 47 of these babies had hearing loss. This equates to a positive predictive value for a refer result of 25%. The observed prevalence of hearing impairment in our population was 0.684%. Diagnostic results for 141 of the referred newborns proved that they had normal hearing. That is, 141 out of 6866 newborns had a false-positive result with the MB11 BERAphone(®) screening. Therefore, the device had a specificity of 97.9%. During the time period of this study, no baby who passed the hearing screening was later found to have hearing impairment, suggesting a sensitivity of 100%. However, due to the limited number of newborns and the short time period after screening for the more recently screened babies, a reliable estimate of the sensitivity cannot be yet made from our program statistics. The theoretical sensitivity of the MB 11 device is 99.9%. CONCLUSIONS: The Maico MB11 BERAphone(®) is a reliable device for auditory brainstem response newborn hearing screening and it provides results within a very short time. Due to the implemented method for automatic detection of ABR, the use of the device does not require an experienced examiner, allowing it to be used by trained technicians in locations outside the department of audiology such as the well-baby nursery.

Investigation of a significant increase in referrals during neonatal hearing screening: a comparison of Natus ALGO Portable and ALGO 3i.

OBJECTIVE: Neonatal hearing screening programs in Flanders and the Netherlands use Natus ALGO screening devices. Since 2006 in Flanders and 2009 in the Netherlands, both programs have replaced the older ALGO Portable devices with the newer ALGO 3i devices. However, in both countries, ALGO 3i devices have a significantly higher rate of referrals than ALGO Portable devices. In Flanders, the refer rate has more than doubled with the switch to ALGO 3i devices. In the Netherlands, screening centers which used ALGO 3i devices also showed a significant increase in referrals. In both countries, the percentage of children diagnosed with permanent hearing loss remained approximately the same. DESIGN: A technical comparison of both device types was carried out to identify possible causes for the increase in referrals. The stimulus output of two ALGO Portable and three ALGO 3i devices was recorded and analysed for stimulus level, spectral properties, and stimulus irregularities. RESULTS: ALGO 3i devices stimulate at a peak level 4.6 dB lower than ALGO Portable devices, have a different stimulus spectrum and show unexplained stimulus irregularities during 4% of the stimulation time. CONCLUSIONS: A number of technical differences were found between both device types which could explain the increase in referrals.

Transcutaneous bilirubin measurement in preterm neonates.

Hyperbilirubinemia is a common problem during neonatal period especially in preterm neonates. Transcutaneous bilirubin measurement (TcB) by special devices had been documented as an effective tool for predicting neonatal jaundice in full term neonate, but for preterm infants the present evidences are controversial. We carried out a prospective study in Shariati Hospital NICU. 126 paired TcB/total serum bilirubin (TSB) measurements were obtained. TcB (on forehead and sternum) were measured using JH2-1A device for every admitted preterm infant who clinically showed jaundice and TSB measurements was obtained within 30 min of TcB. 58 (46%) were male and 68 (54%) were female. The mean gestational age was 31 week and mean birth weight was 1728 ± 60 g. 30 percent of neonates were ill. The mean value obtained by TBS was 8.8 mg/dl and for frontal TcB was 8.2mg/dl and for sternal TcB was 7.4mg/dl. There were good correlation between TBS and TcB and the maximum correlation were seen in 33-37 weeks of gestation and birth weight more than 2500 g with forehead TcB measurement. Healthy preterm infants had significant correlation of TSB and TcB (r=0.56, P<0.001) and ill preterm neonate had r =0.82, P<0.001. The correlation between TBS and TcB with and without phototherapy was r=0.66, P=0.000 and r=0.69, P=0.000 respectively. Although TcB measurement may underestimate TBS but there is significant correlation between TcB and TBS in preterm cases even in ill neonate or who receiving phototherapy. This method can be used for determination of bilirbin level in preterm neonate and reduces the number of blood sampling.