CADTH RAPID RESPONSE REPORT: SUMMARY OF ......transcutaneous bilirubin measurements in well newborns. Additionally, three evidence-based guidelines were identified. Additional references

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CADTH RAPID RESPONSE REPORT: SUMMARY OF ABSTRACTS

Transcutaneous Bilirubin Measurements in Newborns: Clinical and Cost-Effectiveness, and Guidelines

SUMMARY OF ABSTRACTS Transcutaneous Bilirubin Measurements in Newborns 2

Authors: Calvin Young, Lorna Adcock

Cite As: Transcutaneous bilirubin measurements in newborns: clinical and cost -ef f ectiveness, and guidelines. Ottawa: CADTH; 2017 Nov . (CADTH rapid

response report: summary of abstracts).

Acknowledgments:

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Research Questions

1. What is the clinical effectiveness and diagnostic accuracy of transcutaneous bilirubin measurements in newborns?

2. What is the cost-effectiveness of transcutaneous bilirubin measurements in newborns compared with serum bilirubin measurements?

3. What are the evidence-based guidelines regarding transcutaneous bilirubin measurements in newborns?

Key Findings

One health technology assessment report, one systematic review with meta-analysis, one

randomized controlled trial, 21 non-randomized studies, and one economic evaluation were

identified regarding the clinical effectiveness, diagnostic accuracy, or cost-effectiveness of

transcutaneous bilirubin measurements in well newborns. Additionally, three evidence-

based guidelines were identified.

Methods

A limited literature search was conducted on key resources including PubMed, The

Cochrane Library, University of York Centre for Reviews and Dissemination (CRD)

databases and a focused Internet search. No methodological filters were applied to limit

retrieval by publication type. The search was limited to English language documents

published between November 1, 2013 and November 7, 2017.

Selection Criteria

One reviewer screened citations and selected studies based on the inclusion criteria

presented in Table 1.

Table 1: Selection Criteria

Population Well newborns (under 10 days of age), in hospital

Intervention Transcutaneous devices for measuring bilirubin (e.g., Philips BiliChek, Minolta Jaundice Meter , Drager JM-03)

Comparator Q1-Q2: Serum bilirubin measurements Q3: No comparator required

Outcomes Q1: Clinical effectiveness; Diagnostic accuracy (i.e., sensitivity and specificity) Q2: Cost-effectiveness Q3: Evidence-based guidelines

Study Designs Health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, non-randomized studies, economic evaluations, evidence-based guidelines


Results

Rapid Response reports are organized so that the higher quality evidence is presented first.

Therefore, health technology assessment reports, systematic reviews, and meta-analyses

are presented first. These are followed by randomized controlled trials , non-randomized

studies, economic evaluations, and evidence-based guidelines.

One health technology assessment report, one systematic review with meta-analysis, one

randomized controlled trial, 21 non-randomized studies, and one economic evaluation were

identified regarding the clinical effectiveness, diagnostic accuracy, or cost-effectiveness of

transcutaneous bilirubin measurements in well newborns. Additionally, three evidence-

based guidelines were identified.

Additional references of potential interest are provided in the appendix.

Overall Summary of Findings

One health technology assessment (HTA) report,1 one systematic review (SR) with meta-

analysis,2 one randomized controlled trial (RCT),

3 21 non-randomized studies (NRS),

4-24

and one economic evaluation25

were identified regarding the clinical effectiveness,

diagnostic accuracy, or cost-effectiveness of transcutaneous bilirubin (TcB) measurements

in well newborns. Detailed study characteristics are provided in Table 2.

The identified HTA1 concluded that although TcB devices can safely predict neonatal

hyperbilirubinemia they cannot be used as a replacement for total serum bilirubin

measurements (TSB). The SR with meta-analysis2 revealed no significant differences

between TcB and TSB nomograms, suggesting either can be used to identify subsequent

significant hyperbilirubinemia. The conclusions made by the authors of the 23 individual

studies varied greatly.3-25

Fifteen of these studies suggested TcB measurements were well

correlated to serum bilirubin measurements or provided clinical benefit,3,5,7-11,14-19,23

while

seven studies concluded TcB tended to overestimate or underestimate serum bilirubin,

resulting in low levels of correlation.4,6,12,13,21-22,24

Three evidence-based guidelines26-28

were identified regarding transcutaneous bilirubin

measurements in well newborns. One guideline,28

published by the National Institute for

Health and Care Excellence, recommends measuring transcutaneous bilirubin in babies

(gestational age ≥ 35 weeks) who are over 24 hours old. If the transcutaneous

bilirubinometer measurement indicates a bilirubin level greater than 250 micromol/litre, the

guideline recommends measuring the serum bilirubin to check the result and to guide

treatment decisions. The second guideline27

was an update by Wan et al., approved by the

Ministry of Health Malaysia in 2014, to a previous publication. This guideline states that

transcutaneous bilirubinometers may be used in the assessment of neonatal jaundice. This

guideline also contained information on the treatment and prevention of neonatal jaundice.

Finally, the third guideline28

by Wilkinson et al. made a “weak recommendation” to support

screening for hyperbilirubinemia in newborn infants using transcutaneous bilirubin

measurement, early serum bilirubin measurement, or a combination of these methods to

prevent severe complications.


Table 2: Summary of Included Studies on the Clinical Effectiveness, Diagnostic Accuracy,

or Cost-effectiveness of Transcutaneous Bilirubin Measurements in Well Newborns

First Author, Year

Study Characteristics

Intervention Comparator Outcomes Conclusions

Health Technology Assessments

Institute of Health Economics, 2013

1

39 primary studies included

SR and critical appraisal conducted

Economic analysis performed

TcB screening

TSB

Visual assessment

Comparison between TcB devices

Diagnostic accuracy

Procedure-related adverse events

Incidence of significant neonatal hyperbilirubinemia

Cost-effectiveness

The BiliCheck and JM-103 devices provided a rapid, non-invasive, point-of-care test for predicting neonatal hyperbilirubinemia that appeared to be safe

TcB screening cannot replace TSB due to the potential for both overestimation and underestimation of TSB values

TcB was useful as a valid screening tool to determine the need for a confirmatory TSB test

The cost-effectiveness of TcB screening was uncertain

Systematic Reviews and Meta-Analyses

Yu, 20142

MA performed

14 studies included

N=NR

TcB nomograms

TSB nomograms

Predictive value for significant hyperbilirubinemia

MA revealed no difference in the predictive abilities of TcB and TSB nomograms

The authors stated that this result should be taken with caution due to methodological limitations of the studies included in this SR

Randomized Controlled Trials

van den Esker-Jonker, 2016

3 Hospitalized

jaundiced neonates (gestational age ≥ 32 weeks)

N=430

TcB to determine need for TSB

Visual and clinical assessment to determine need for TSB

Number of blood samples before phototherapy

Peak of bilirubin value

Indications for phototherapy

Exchange transfusion

Length of hospitalization

The number of blood draws was significantly reduced (by 38.5%) in the TcB group

There were no significant differences in other outcomes of interest between groups

The authors concluded TcB was safe, feasible, and resulted in a decrease in the number of blood draws


First Author, Year



Non-Randomized Studies

Fine, 20174

Preterm and term infants

N=NR

TcB measurement

TSB measurement

Sensitivity and specificity of TcB

“Median TcB b ias was 2.6 and 2.5 mg dl

-1 for term

and preterm infants in the

first 3 days of life, respectively. However, median b ias was 2.2 mg dl

-

1 for preterm infants at 4 to

7 days of life. TcB in

preterm infants predicted high-intermediate or high-risk TSB with 94% sensitivity and 56% specificity. TcB screening protocols developed for term infants can be used for late preterm infants in the first 3 days of life.”

4

Jain, 20175

Healthy, term, appropriate for gestational age neonates

N=500

TcB at 24 and 48 hours of age

TSB at 72 hours of age

Sensitivity

Specificity Predictive values

TcB cut-off values of 7 mg/dL at 24 hours and 10 mg/dL at 48 hours were identified as the most effective in predicting subsequent hyperbilirubinemia

The authors concluded 24 hour and 48 hour TcB values were good predictors of subsequent hyperbilirubinemia (24 hour value had stronger predictive ability)

Jones, 20176

Newborns

N=178

TcB measurement (with JM-105 and BiliChek devices)

TSB measurement

TcB/TSB correlation

The highest TcB/TSB correlation with the JM-105 device was achieved on the sternum, with an overall correlation value of 0.93

TcB accuracy varied among races

In 5% of measurements, TcB with JM-105 on the sternum underestimated TSB by ≥2 mg/dL

Nahar, 20177

Late preterm and term newborns (gestational age ≥ 35 weeks)

N=160

TcB measurement

TSB measurement

Mean difference of TcB and TSB

Sensitivity Specificity

Accuracy

A sensitivity of 77%, specificity of 88%, and accuracy of 82% were obtained using a TcB cut off value of 15 mg/dl

The authors concluded TcB can reduce the


First Author, Year



need for TSB in neonates

Olusanya, 2017

8 Infants with

paired TcB and TSB measurements

N=1,011

TcB measurement

TSB measurement

Predictive performance of TcB

TcB demonstrated NPVs of 99.0-99.9% and PPVs of 7.7-15.5% across all criteria

TcB was effective in identifying infants that do not require phototherapy. However, it may identify a high proportion of false positives

Yamana, 20179

Japanese newborns (gestational age ≥ 35 weeks)

N=82

TcB measurement (with BiliCare system)

TSB measurement

TcB measurement (with JM-105)

TcB/TSB correlation


TcB significantly correlated with TSB

TcB measured at the scaphoid fossa or conchal cavity were more reliable than those at the earlobe

Alsaedi, 201610

Healthy, jaundiced Saudi term newborns

N=665

TcB measurement

TSB measurement

TcB/TSB correlation

Sensitivity

Specificity PPV

NPV

TcB sensitivity and specificity to predict TSB during the first 72 hours of life were estimated at 83% and 71%, respectively

A PPV of 63% and a NPV of 87% were reported

The authors concluded TcB measurement provided accurate estimates of TSB values

Kitsommart, 2016

11 Healthy late

preterm and term infants

N=114 paired samples (from 93 infants)

TcB measurement(with BiliCare system)

TSB measurement


Sensitivity

NPV

“The BiliCare(TM) demonstrated good performance with positive b ias for the screening of jaundice in healthy late preterm or term infants. However, if adopted, proper cut-off levels should be chosen because of sub -optimal device precision.”

11

Olusanya, 2016

12 Black African

neonates N=2,107 paired

samples (from 1,553 infants)

TcB measurement (with JM-105 and BiliChek devices)

TSB measurement

Divergence between TcB and TSB values

Both the BiliChek and the JM-103 devices overestimate TSB in black African neonates, which may result in unnecessary treatments

JM-103 device was associated with higher


First Author, Year



levels of overestimation than the BiliChek device

Pratesi, 201613

Late preterm and term Caucasian infants with non-hemolytic jaundice (gestational age ≥ 35 weeks)

N=458

TcB measurement (with BiliCare)

TcB measurement (with JM-105)

TSB measurement

Mean difference of TcB between devices

TcB measurements with both devices were well correlated

BiliCare tended to over-estimate TsB for mild and moderate values and under-estimate it for high values compared to JM-103

Comparison between TcB and TSB were not made in the abstract

Afjeh, 201514

Neonates weighing ≥ 1,800 g (gestational age ≥ 35 weeks)

N=613

TcB measurement

TSB measurement

TcB/TSB correlation

PPV

TcB demonstrated a PPV of 81% for the diagnosis of hyperbilirubinemia

A correlation coefficient of 72% was observed between TcB and TSB

Authors highly recommended TcB to be performed routinely due to high incidence of hyperbilirubinemia in neonates

Mahram, 2015

15 Neonates

admitted to hospital because of neonatal indirect jaundice

N=256

TcB measurement (with KJ-8000 device)

TSB measurement

TcB/TSB correlation

Sensitivity

Specificity

TcB/TSB correlation was observed to be 0.82

Sensitivity and specificity were found to be 0.844 and 0.842, respectively

The authors concluded that TcB can be used as a reliable tool to bilirubin in neonates

Taylor, 201516

Neonates admitted to participating newborn nurseries

N=8,319

TcB measurement

TSB measurement


TcB/TSB correlation

The mean difference between TcB and TSB values was 0.84 mg/dL

Mean difference between TcB and TSB values was higher in African-American newborns

The correlation between paired TcB/TSB measurements was 0.78

The authors concluded that Tcb measurement provided a reasonable estimate of TSB levels in


First Author, Year



healthy newborns

Afanetti, 201417

Preterm and term infants

N=85

TcB measurement (with Draeger JM-103(R) device)

TSB measurement

Correlation and agreement between TcB and TSB values

“TcB measurements using the Draeger JM-103(R) device correlate

significantly with TSB, regardless of term and skin color. Transcutaneous b ilirubinometry seems to be a safe and cost-effective

screening method for severe hyperb ilirubinemia in newborns of different terms and ethnic origins.”

17

Conceicao, 2014

18 Term newborns

with no hemolytic disease

N=58

TcB measurement (performed on the forehead or sternum with Bilicheck(R) device)

TSB measurement


TcB measurement on the sternum was more effective than when measured on the forehead

Mean TcB values measured on the sternum corresponded well with TSB values

Mazur, 201419

Low-risk newborn infants with normal bilirubin levels N=34

TcB measurement (with JM103 device)

TSB measurement

Differences and limits of agreement between sequential measurements

“We found good agreement between TcB measurements obtained sequentially by a single user and by two different users of the device, as well as between laboratory TSB values in low-risk newborn infants with normal b ilirubin levels. These findings support the use of a noninvasive b ilirubin meter to screen for hyperb ilirubinemia, which

could reduce the amount of b lood obtained invasively from newborns”

19

Mohamed, 2014

20 Healthy term

and near-term newborns

N=141

Plotting TcB values on a transcutaneous nomograms (Fouzas et al. and Maisels and Kring)

Plotting TcB values on a TSB nomogram

Plotting TSB values on a TSB nomogram (Bhutani et al.)

Risk of developing significant hyperbilirubinemia

False negative rate Sensitivity

Specificity

PPV and NPV

Plotting TcB values on a TSB nomogram was associated with higher false negative rate and decreased predictive characteristics


First Author, Year



(Bhutani et al.)

Neocleous, 2014

21 Clinically

jaundiced healthy-term Greek newborns

N=368 paired samples (from 222 infants)

TcB measurement (with BiliCheck device)

TSB measurement

Level of agreement between TcB and TSB values

TcB and TSB values did not correlate well

TcB tended to overestimate TSB with wide 95% limits of agreement

Rylance, 2014

22 Jaundiced

newborn infants

N=128

TcB measurement (from forehead and sternum)

TSB measurement


Sensitivity Specificity

TcB values tended to overestimate the degree of jaundice

A sensitivity of 91% and a specificity of 90% were observed in infants not undergoing phototherapy

For infants undergoing phototherapy, TcB had good sensitivity (94%), but lower specificity (36%)

The authors concluded TcB can be used to safely guide phototherapy in a resource-poor setting

Samiee-Zafarghandy, 2014

23

Newborns of various skin colours

N=451


TSB measurement

Association between TcB and TSB values

TcB underestimated TSB in light and medium skin colours infants and overestimated TSB in dark skin colour

The authors concluded that the JM103 device was a useful screening tool to identify infants in need of TSB, regardless of their skin colour

Simsek, 201424

Healthy Turkish neonates (gestational age ≥ 36 weeks)

N=250


TSB measurement

Correlation between TcB and TSB values


TcB tended to underestimate TSB, with a larger discrepancy at higher TSB values

The mean difference of TcB and TSB was lower in infants not requiring phototherapy than infants that required phototherapy

The JM-103 device is a suitable screening tool to identify jaundiced infants


First Author, Year



and it may reduce the need for TSB measurements

Economic Evaluations

Srinivas, 2016

25 Neonates

admitted only to the Level 1 nursery (gestational age ≥ 37 weeks)

N=552

TcB measurement (with BiliChek(R) meter)

TSB measurement

Correlation between TcB and TSB values

NPV

Potential cost savings

Correlation between TcB and TSB was estimated at 0.69

A NPV of 99.4% was reported

TcB use was associated with a potential cost savings of $1500.00 per 100 patients

The authors concluded TcB can used as a stand-alone test until values are close to phototherapy threshold

MA = meta-analy sis; NPV = negativ e predictiv e v alue; NR = not reported; PPV = positiv e predictiv e v alue; TcB: transcutaneous bilirubin; TSB = total serum bilirubin; RCT

= randomized controlled trial; SR = sy stematic rev iew.

References Summarized

Health Technology Assessments

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the-screening-of-neonatal-hyperbilirubinemia


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21. Mohamed I, Blanchard AC, Delvin E, Cousineau J, Carceller A. Plotting transcutaneous

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pilot study. Neonatology. 2014;105(4):306-11.

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22. Neocleous C, Adramerina A, Limnaios S, Symeonidis S, Spanou C, Malakozi M, et al. A

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reliably conservative method of assessing neonatal jaundice. J Matern Fetal Neonatal

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Guidelines and Recommendations

27. Jaundice in newborn babies under 28 days [Internet]. London: National Institute for

Health Care and Excellence (NICE); 2016 Oct. [cited 2017 Nov 20]. (Clinical guideline;

no. 98). Available from: https://www.nice.org.uk/guidance/cg98

See: Transcutaneous b ilirubin screening and risk factors, page 22

28. Wan A, Mat DS, Teh SH, Choo YM, Kutty FM. Management of neonatal jaundice in

primary care. Malays Fam Physician [Internet]. 2016 [cited 2017 Nov 20];11(2-3):16-9.

Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5408871

PubMed: PM28461853

29. Wilkinson J, Bass C, Diem S, Gravley A, Harvey L, Maciosek M, et al. Health care

guideline: preventive services for children and adolescents [Internet]. Bloomington

(MN): Institute for Clinical Systems Improvement; 2013 Sept. Available from:

http://www.doc4teens.com/support-files/adolescent-preventative-services.pdf

See: 23. Hyperb ilirubinemia Screening, page 38

http://www.ncbi.nlm.nih.gov/pubmed/25074981http://www.ncbi.nlm.nih.gov/pubmed/26388591http://www.ncbi.nlm.nih.gov/pubmed/26483074https://www.nice.org.uk/guidance/cg98http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5408871http://www.ncbi.nlm.nih.gov/pubmed/28461853http://www.doc4teens.com/support-files/adolescent-preventative-services.pdf


Appendix — Further Information

Previous CADTH Reports

30. Transcutaneous bilirubin measurements in newborns: clinical and cost-effectiveness,

and guidelines [Internet]. Ottawa: CADTH; 2013 Dec 9 [cited 2017 Nov 20]. (CADTH

rapid response report: summary of abstracts). Available from:

https://www.cadth.ca/transcutaneous-bilirubin-measurements-newborns-clinical-and-

cost-effectiveness-and-guidelines


Alternative Population – Newborns Receiving Phototherapy

31. Nagar G, Vandermeer B, Campbell S, Kumar M. Effect of phototherapy on the reliability

of transcutaneous bilirubin devices in term and near-term infants: a systematic review

and meta-analysis. Neonatology. 2016;109(3):203-12.

PubMed: PM26789390

Alternative Population – Preterm Infants

32. Nagar G, Vandermeer B, Campbell S, Kumar M. Reliability of transcutaneous bilirubin

devices in preterm infants: a systematic review. Pediatrics. 2013 Nov;132(5):871-81.

PubMed: PM24127472


Alternative Population – Newborns Receiving Phototherapy

33. Katayama Y, Enomoto M, Kikuchi S, Takei A, Ikegami H, Minami H, et al.

Transcutaneous bilirubin measurement during phototherapy in term neonates. Pediatr

Int. 2017 Jun;59(6):686-90.

PubMed: PM28118513

34. Murli L, Thukral A, Sankar MJ, Vishnubhatla S, Deorari AK, Paul VK, et al. Reliability of

transcutaneous bilirubinometry from shielded skin in neonates receiving phototherapy: a

prospective cohort study. J Perinatol. 2017 Feb;37(2):182-7.

PubMed: PM27763628

35. Casnocha LL, Matasova K, Zibolen M, Krcho P. Accuracy of transcutaneous b ilirubin

measurement in newborns after phototherapy. J Perinatol. 2016 Oct;36(10):858-61.

PubMed: PM27279078

36. Radfar M, Hashemieh M, Shirvani F, Madani R. Transcutaneous bilirubinometry in

preterm and term newborn infants before and during phototherapy. Arch Iran Med. 2016

May;19(5):323-8.

PubMed: PM27179163

37. Grabenhenrich J, Grabenhenrich L, Buhrer C, Berns M. Transcutaneous bilirub in after

phototherapy in term and preterm infants. Pediatrics. 2014 Nov;134(5):e1324-e1329.

PubMed: PM25332501

https://www.cadth.ca/transcutaneous-bilirubin-measurements-newborns-clinical-and-cost-effectiveness-and-guidelineshttps://www.cadth.ca/transcutaneous-bilirubin-measurements-newborns-clinical-and-cost-effectiveness-and-guidelineshttp://www.ncbi.nlm.nih.gov/pubmed/26789390http://www.ncbi.nlm.nih.gov/pubmed/24127472http://www.ncbi.nlm.nih.gov/pubmed/28118513http://www.ncbi.nlm.nih.gov/pubmed/27763628http://www.ncbi.nlm.nih.gov/pubmed/27279078http://www.ncbi.nlm.nih.gov/pubmed/27179163http://www.ncbi.nlm.nih.gov/pubmed/25332501


38. Juster-Reicher A, Flidel-Rimon O, Rozin I, Shinwell ES. Correlation of transcutaneous

bilirubinometry (Tcb) and total serum bilirubin (TsB) levels after phototherapy. J Matern

Fetal Neonatal Med. 2014 Sep 30;1-3.

PubMed: PM25234102

Clinical Practice Guidelines – Uncertain Methodology

39. Jaundice and hyperbilirubinemia in the newborn: assessment and management

[Internet]. Winnipeg (MB): Winnipeg Regional Health Authority, 2017 Jan [cited 2017

Nov 20]. Available from: http://www.wrha.mb.ca/extranet/eipt/files/EIPT-035-024.pdf

40. Guidelines for detection, management and prevention of hyperbilirubinemia in term and

late preterm newborn infants [Internet]. Toronto: Canadian Paediatric Society; 2016 Feb

1 [cited 2017 Nov 20]. Available from:

https://www.cps.ca/en/documents/position/hyperbilirubinemia-newborn

41. Queensland maternity and neonatal guideline: neonatal jaundice [Internet]. Brisbane

(AU): Queensland Health; 2012 Nov [cited 2017 Nov 20]. Available from:

https://www.health.qld.gov.au/__data/assets/pdf_file/0018/142038/g_jaundice.pdf

Review Articles

42. Bhardwaj K, Locke T, Biringer A, Booth A, Darling EK, Dougan S, et al. Newborn

bilirubin screening for preventing severe hyperbilirubinemia and bilirubin

encephalopathy: a rapid review. Curr Pediatr Rev. 2017;13(1):67-90.

PubMed: PM28071585

43. Maisels MJ. Transcutaneous bilirubin measurement: does it work in the real world?

Pediatrics. 2015 Feb;135(2):364-6.

PubMed: PM25601975

44. Engle WD, Jackson GL, Engle NG. Transcutaneous bilirubinometry. Semin Perinatol.

2014 Nov;38(7):438-51.

PubMed: PM25282473

45. Muchowski KE. Evaluation and treatment of neonatal hyperbilirubinemia. Am Fam

Physician. 2014 Jun 1;89(11):873-8.

PubMed: PM25077393
http://www.ncbi.nlm.nih.gov/pubmed/25234102http://www.wrha.mb.ca/extranet/eipt/files/EIPT-035-024.pdfhttps://www.cps.ca/en/documents/position/hyperbilirubinemia-newbornhttps://www.health.qld.gov.au/__data/assets/pdf_file/0018/142038/g_jaundice.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/28071585http://www.ncbi.nlm.nih.gov/pubmed/25601975http://www.ncbi.nlm.nih.gov/pubmed/25282473http://www.ncbi.nlm.nih.gov/pubmed/25077393

Documents

CADTH RAPID RESPONSE REPORT: SUMMARY OF ......transcutaneous bilirubin measurements in well newborns. Additionally, three evidence-based guidelines were identified. Additional references