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DOI: 10.1542/peds.2011-1494; originally published online September 26, 2011;2011;128;e1046Pediatrics

Vinod K. Bhutani and the Committee on Fetus and NewbornInfant 35 or More Weeks of Gestation

Phototherapy to Prevent Severe Neonatal Hyperbilirubinemia in the Newborn

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TECHNICAL REPORT

Phototherapy to Prevent Severe Neonatal

Hyperbilirubinemia in the Newborn Infant 35 or MoreWeeks of Gestation

abstractOBJECTIVE:To standardize the use of phototherapy consistent with the American Academy of Pediatrics clinical practice guideline for themanagement of hyperbilirubinemia in the newborn infant 35 or moreweeks of gestation.

METHODS:Relevant literature was reviewed. Phototherapy devicescurrently marketed in the United States that incorporate uorescent,halogen, ber-optic, or blue light-emitting diode light sources wereassessed in the laboratory.

RESULTS: The efcacy of phototherapy units varies widely because of differences in light source and conguration. The following character-istics of a device contribute to its effectiveness: (1) emission of light in the blue-to-green range that overlaps the in vivo plasma bilirubin ab-sorption spectrum ( 460490 nm); (2) irradiance of at least 30

Wcm 2 nm 1 (conrmed with an appropriate irradiance meter cal-ibrated over the appropriate wavelength range); (3) illumination of maximal body surface; and (4) demonstration of a decrease in totalbilirubin concentrations during the rst 4 to 6 hours of exposure.

RECOMMENDATIONS (SEE APPENDIX FOR GRADING DEFINITION):Theintensity and spectral output of phototherapy devices is useful in pre-dicting potential effectiveness in treating hyperbilirubinemia (group Brecommendation). Clinical effectiveness should be evaluated beforeand monitored during use (group B recommendation). Blocking thelight source or reducing exposed body surface should be avoided(group B recommendation). Standardization of irradiance meters, im-provements in device design, and lower-upper limits of light intensityfor phototherapy units merit further study. Comparing the in vivo per-formance of devices is not practical, in general, and alternative proce-dures need to be explored. Pediatrics 2011;128:e1046e1052

Vinod K. Bhutani, MD, and THE COMMITTEE ON FETUS ANDNEWBORN

KEY WORDSphototherapy, newborn jaundice, hyperbilirubinemia, light treatment

ABBREVIATIONLEDlight-emitting diode

This document is copyrighted and is property of the AmericanAcademy of Pediatrics and its Board of Directors. All authorshave led conict of interest statements with the AmericanAcademy of Pediatrics. Any conicts have been resolved througha process approved by the Board of Directors. The AmericanAcademy of Pediatrics has neither solicited nor accepted anycommercial involvement in the development of the content of this publication.

The guidance in this report does not indicate an exclusivecourse of treatment or serve as a standard of medical care.Variations, taking into account individual circumstances, may beappropriate.

www.pediatrics.org/cgi/doi/10.1542/peds.2011-1494

doi:10.1542/peds.2011-1494

All technical reports from the American Academy of Pediatricsautomatically expire 5 years after publication unless reafrmed,

revised, or retired at or before that time.

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright 2011 by the American Academy of Pediatrics

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II. STANDARDS FORPHOTOTHERAPY DEVICES

Methods for reporting and measuringphototherapy doses are not standard-ized. Comparisons of commerciallyavailable phototherapy devices thatuse in vitro photodegradation tech-niques maynot accurately predict clin-ical efcacy. 2 A recent report exploredan approach to standardizing and

quantifying the magnitude of phototherapy delivered by various devices. 3

Table 1 lists technical data for some of the devices marketed in the UnitedStates. 3 Factors to consider in pre-scribing and implementing photother-apy are (1) emission range of the lightsource, (2) the light intensity (irradi-ance), (3) the exposed (treatable)body surface area illuminated, and (4) the decrease in total bilirubin concentration. A measure of the effectivenessof phototherapy to rapidly congure the bilirubin molecule to less toxic pho- toisomers (measured in seconds) isnot yet clinically available.

A. Light Wavelength

The visible white light spectrumranges from approximately 350 to 800nm. Bilirubin absorbs visible lightmost strongly in the blue region of thespectrum ( 460 nm). Absorption of

light transforms unconjugated biliru-bin molecules bound to human serumalbumin in solution into bilirubin pho- toproducts (predominantly isomers of bilirubin). 2,4,5 Because of the photo-physical properties of skin, the mosteffective light in vivo is probably in theblue-to-green region ( 460490nm). 2 The rst prototype phototherapydevice to result in a clinically signi-cant rate of bilirubin decrease used ablue (B) uorescent-tube light sourcewith 420- to 480-nm emission. 6,7 Moreeffective narrow-band special bluebulbs (F20T12/BB [General Electric,Westinghouse, Sylvania] or TL52/20W[Phillips]) were subsequently used. 8,9

Most recently, commercial compactuorescent-tube light sources and de-vices that use LEDs of narrow spectralbandwidth have been used. 914 Unlessspecied otherwise, plastic covers or

optical lters need to be used to re-move potentially harmful ultravioletlight.

Clinical Context

Devices with maximum emissionwithin the 460- to 490-nm (blue-green)region of the visible spectrum areprobably the most effective for treat-ing hyperbilirubinemia. 2,4 Lights withbroader emission also will work, al-

though not as effectively. Special blue(BB) uorescent lights are effectivebut should not be confused with whitelights painted blue or covered withblue plastic sheaths, which should notbe used. Devices that contain high-intensity gallium nitride LEDs withemission within the 460- to 490-nm re-gions are also effective and have a lon-ger lifetime ( 20 000 hours), lowerheat output, low infrared emission,and no ultraviolet emission.

B. Measuring Light Irradiance

Light intensity or energy output is de-ned by irradiance and refers to thenumber of photons (spectral energy) that are delivered per unit area (cm 2 )of exposed skin. 1 The dose of phototherapy is a measure of the irradiancedelivered for a specic duration andadjusted to the exposed body surfacearea. Determination of an in vivo dose-response relationship is confoundedby the optical properties of skin and the rates of bilirubin production andelimination. 1 Irradiance is measuredwith a radiometer (Wcm 2 ) or spec- troradiometer ( Wcm 2 nm 1 ) overa given wavelength band. Table 2 com-pares the spectral irradiance of someof the devices in the US market, asmeasured with different brands of me-

TABLE 2 Maximum Spectral Irradiance of Phototherapy Devices (Using Commercial Light Meters at Manufacturer Recommended Distances) Compared to Clear-Sky Sunlight

Light Meter [Range, Peak] Footprint Irradiance, ( W/cm2 /nm a )

Halogen/Fiberoptic Fluorescent LED Sunlight

BiliBlanket Wallaby (Neo) PEP Bed Martin/PhilipsBB

neoBLUE PortaBed @ Zenith on8/31/05

II III

@ Contact @ Contact @ 10 cm @ 25 cm @ 30 cm @ 10 cm Level Ground

BiliBlanket Meter II [400520, 450 nm] 34 28 34 40 69 34 76 144Bili-Meter, Model 22 [425475, 460 nm] 29 16 32 49 100 25 86 65 **

Joey Dosimeter, JD-100 [420550, 470 nm] 53 51 60 88 174 84 195 304 **

PMA-2123 Bilirubin Detector a (400520, 460 nm) 24 24 37 35 70 38 73 81GoldiLux UVA Photometer, GRP-1b [315400, 365 nm] 0.04 0.04 0.04 0.04 0.04 0.04 0.04 2489

Data in Table 2 were tested and compiled by Hendrik J. Vreman (June 2007 and reveried December 2010).** Irradiancepresentedto thismeter exceeded itsrange. Measurementwas madethrough a stainless-steelscreen thatattenuatedthe measured irradianceto 57%,which wassubsequentlycorrected by this factor.a Solar Light Company, Inc., Glenside, PA 19038.b Oriel Instruments, Stratford, CT 06615 and SmartMeter GRP-1 with UV-A probe. GRP-1 measures UV-A light as W/cm2 . No articial light source delivered signicant ( 0.04 W/cm2 ) UV-Aradiation at the distances measured.



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ters. Often, radiometers measurewavelengths that do notpenetrateskinwell or that are far from optimal forphototherapyand, therefore, maybe of little value for predicting the clinicalefcacy of phototherapy units. A direct

relationship between irradiance and the rate of in vivo total bilirubin con-centration decrease was described in the report of a study of term healthyinfants with nonhemolytic hyperbiliru-binemia (peak values: 1518 mg/dL)using uorescent Philips daylight(TL20W/54, TL20W/52) and special blue(TLAK 40W/03) lamps.15,16 The AmericanAcademy of Pediatrics has recom-mended that the irradiance for inten-

sive phototherapy be at least 30Wcm 2 nm 1 over the waveband in-

terval 460 to 490 nm. 1 Devices that emitlower irradiance may be supple-mented with auxiliary devices. Muchhigher doses ( 65 Wcm 2 nm 1 )might have (as-yet-unidentied) ad-verse effects. Currently, no singlemethod is in general use for measur-ing phototherapy dosages. In addition, the calibration methods, wavelengthresponses, and geometries of instru-ments are not standardized. Conse-quently, different radiometers mayshow different values for the samelight source. 2

Clinical Context

For routine measurements, cliniciansare limited by reliance on irradiancemeters supplied or recommended by the manufacturer. Visual estimationsof brightness and use of ordinary pho- tometric or colorimetric light metersare inappropriate. 1,2 Maximal irradi-ance can be achieved by bringing thelight source close to the infant 1; how-ever, this should not be done with hal-ogen or tungsten lights, because theheat generated can cause a burn. Fur- thermore, with some xtures, increas-ing the proximity may reduce the ex-posed body surface area. Irradiancedistribution in the illuminated area

(footprint) is rarely uniform; measure-ments at the center of the footprintmay greatly exceed those at the pe-riphery and are variable among phototherapy devices. 1 Thus, irradianceshould be measured at several sites

on the infants body surface. The idealdistance and orientation of the lightsource should be maintained accord-ing to the manufacturers recommen-dations. The irradiance of all lamps de-creases with use; manufacturersmay provide useful-lifetime estimates,which should not be exceeded.

C. Optimal Body Surface Area

An infants total body surface area 17

can be inuenced by the dispropor- tionate head size, especially in themore preterm infant. Complete (100%)exposure of the total body surface tolight is impractical and limited by useof eye masks and diapers. Circumfer-ential illumination (total body surfaceexposure from multiple directions)achieves exposure of approximately80% of the total body surface. In clini-cal practice, exposure is usually pla-nar: ventral with overhead lightsources and dorsal with lighted mattresses. Approximately 35% of the totalbody surface (ventral or dorsal) is ex-posed with either method. Changing the infants posture every 2 to 3 hoursmay maximize the area exposed tolight. Exposed body surface area treated rather than the number of de-vices (double, triple, etc) used is clini-cally more important. Maximal skinsurface illumination allows for a moreintensive exposure and may requirecombined use of more than 1 phototherapy device. 1

Clinical Context

Physical obstruction of light by equip-ment, such as radiant warmers, headcovers, large diapers, eye masks thatenclose large areas of the scalp, tape,electrode patches, and insulating plastic covers, decrease the exposed skin

surface area. Circumferential phototherapy maximizes the exposed area.Combiningseveral devices, such as u-orescent tubes with ber-optic pads orLED mattresses placed below the in-fant or bassinet, will increase the sur-

face area exposed. If the infant is in anincubator, the light rays should be per-pendicular to the surface of the incu-bator to minimize reectance and lossof efcacy. 1,2

D. Rate of Response Measured byDecrease in Serum BilirubinConcentration

The clinical impact of phototherapyshould be evident within 4 to 6 hours of

initiation with an anticipated decreaseof more than 2 mg/dL (34 mol/L) inserum bilirubin concentration. 1 Theclinical response dependson the ratesof bilirubin production, enterohepaticcirculation, and bilirubin elimination; the degree of tissue bilirubindeposition 15,16,18 ; and the rates of thephotochemical reactions of bilirubin.Aggressive implementation of phototherapy for excessive hyperbiliru-binemia, sometimes referred to as thecrash-cart approach, 19,20 has beenreported to reduce the need for ex-change transfusion and possiblyreduce the severity of bilirubinneurotoxicity.

Clinical Context

Serial measurements of bilirubin con-centration are used to monitor the ef-fectiveness of phototherapy, but thevalue of these measurements can beconfounded by changes in bilirubinproduction or elimination and by asudden increase in bilirubin concentration (rebound) if phototherapy isstopped. Periodicity of serial measure-ments is based on clinical judgment.

III. EVIDENCE FOR EFFECTIVEPHOTOTHERAPY

Light-emission characteristics of phototherapy devices help in predicting

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their effectiveness (group B recom-

mendation) (see Appendix) . The clini-cal effectiveness of the device shouldbe known before and monitored dur-ing clinical application (group B rec-ommendation). Local guidelines (in-structions) for routine clinical useshould be available. Important factors that need to be considered are listed inTable 3. Obstructing the light sourceand reducing the exposed body sur-face area must be avoided (group Brecommendation).

These recommendationsare appropri-ate for clinical care in high-resourcesettings. In low-resource settings theuse of improvised technologies and af-fordable phototherapy device choicesneed to meet minimum efcacy andsafety standards.

IV. SAFETY AND PROTECTIVEMEASURES

A clinician skilled in newborn careshould assess the neonates clinicalstatus during phototherapy to ensureadequate hydration, nutrition, and temperature control. Clinical improve-ment or progression of jaundiceshould also be assessed, includingsigns suggestive of early bilirubin en-cephalopathy such as changes insleeping pattern, deteriorating feed-ing pattern, or inability to be consoledwhile crying. 1 Staff should be educated

regarding the importance of safely

minimizing the distance of the phototherapy device from the infant. Theyshould be aware that the intensity of light decreases at the outer perimeterof the light footprint and recognize theeffects of physical factors that couldimpede or obstruct light exposure.Staff should be aware that photother-apy does not use ultraviolet light and that exposure to the lights is mostlyharmless. Four decades of neonatal

phototherapy use has revealed noserious adverse clinical effects innewborn infants 35 or more weeks of gestation. For more preterm infants,who are usually treated with prophy-lactic rather than therapeutic phototherapy, this may not be true. In-formed staff should educate parentsregarding the care of their newborninfant undergoing phototherapy. De-vices must comply with general

safety standards listed by the Inter-national Electrotechnical Commis-sion. 21 Other clinical considerationsinclude:

a. Interruption of phototherapy: Aftera documented decrease in bilirubinconcentration, continuous expo-sure to the light source may be in- terrupted and the eye mask re-moved to allow for feeding andmaternal-infant bonding. 1

b. Use of eye masks: Eye masks to pre-vent retinal damage are used rou- tinely, although there is no evidence to support this recommendation.Retinal damage has been docu-mented in the unpatched eyes ofnew-

born monkeys exposed to photother-apy, but there are no similar dataavailable from human newborns, be-cause eye patches have always beenused. 2224 Purulenteye discharge andconjunctivitis in term infants havebeen reported with prolonged use of eye patches. 25,26

c. Use of diapers: Concerns for thelong-term effects of continuousphototherapy exposure of the re-productive system have beenraised but not substantiated. 2729 Di-apers may be used for hygiene butare not essential.

d. Other protective considerations:Devices used in environments withhigh humidity and oxygen mustmeet electrical and re hazardsafety standards. 21 Phototherapy iscontraindicated in infants with con-

genital porphyria or those treatedwith photosensitizing drugs. 1 Pro-longed phototherapy has been asso-ciated with increased oxidant stressand lipid peroxidation 30 and riboa-vin deciency. 31 Recent clinical re-ports of otheradverse outcomes (eg,malignant melanoma, DNA damage,and skin changes) have yet to be val-idated. 1,2,32,33 Phototherapy does notexacerbate hemolysis. 34

V. RESEARCH NEEDS

Among the gaps in knowledge that re-main regarding the use of photother-apy to prevent severe neonatal hyper-bilirubinemia, the following are among the most important:

1. The ability to measure the actualwavelength and irradiance deliveredby a phototherapy device is urgentlyneeded to assess the efciency of

TABLE 3 Practice Considerations for Optimal Administration of Phototherapy

Checklist Recommendation Implementation

Light source (nm) Wavelength spectrum in 460- 490-nmblue-green light region

Know the spectral output of the lightsource

Light irradiance( Wcm 2 nm 1 )

Use optimal irradiance: 30Wcm 2 nm 1 within the 460- to

490-nm waveband

Ensure uniformity over the lightfootprint area

Body surface area (cm2

) Expose maximal skin area Reduce blocking of l ightTimeliness of

implementationUrgent or crash-cart intervention for

excessive hyperbilirubinemiaMay conduct procedures while

infant is on phototherapyContinuity of therapy Briey interrupt for feeding, parental

bonding, nursing careAfter conrmation of adequate

bilirubin concentration decreaseEfcacy of intervention Periodically measure rate of response

in bilirubin load reductionDegree of total serum/plasma

bilirubin concentration decreaseDuration of therapy Discontinue at desired bilirubin

threshold; be aware of possiblerebound increase

Serial bilirubin measurementsbased on rate of decrease



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phototherapy inreducing total serumbilirubin concentrations.

2. The safety and efcacy of home phototherapy remains a researchpriority.

3. Further delineation of the short-and long-term consequences of ex-posing infants with conjugated andunconjugated hyperbilirubinemia to phototherapy is needed.

4. Whether use of phototherapy re-duces the risk of bilirubin neurotox-icity in a timely and effective man-ner needs further exploration.

SUMMARY

Clinicians and hospitals should ensure that the phototherapy devices they usefully illuminate the patients body sur-

face area, have an irradiance level of 30 Wcm 2 nm 1 (conrmed withaccuracy with an appropriate spectralradiometer) over the waveband of ap-proximately 460 to 490 nm, and areimplemented in a timely manner. Stan-

dard procedures should be docu-mented for their safe deployment.

LEAD AUTHORVinod K. Bhutani, MD

COMMITTEE ON FETUS AND NEWBORN,20102011Lu-Ann Papile, MD, ChairpersonJill E. Baley, MDVinod K. Bhutani, MDWaldemar A. Carlo, MDJames J. Cummings, MDPraveen Kumar, MD

Richard A. Polin, MDRosemarie C. Tan, MD, PhDKristi L. Watterberg, MD

FORMER COMMITTEE MEMBERDavid H. Adamkin, MD

LIAISONSCAPT Wanda Denise Bareld, MD, MPH

Centers for Disease Control and Prevention William H. Barth Jr, MD American College of

Obstetricians and Gynecologists Ann L. Jefferies, MD Canadian Paediatric

Society Rosalie O. Mainous, PhD, RNC, NNP National

Association of Neonatal Nurses Tonse N. K. Raju, MD, DCH National Institutes

of Health Kasper S. Wang AAP Section on Surgery

CONSULTANTSM. Jeffrey Maisels, MBBCh, DScAntony F. McDonagh, PhDDavid K. Stevenson, MDHendrik J. Vreman, PhD

STAFFJim Couto, MA

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Quantum yields for laser photocyclizationof bilirubin in the presence of human se-rum albumin: dependence of quantum yieldon excitation wavelength. Photochem Pho- tobiol . 1989;50(3):305319

3. Vreman HJ, Wong RJ, Murdock JR, Steven-son DK. Standardized bench method forevaluating the efcacy of phototherapy de-vices. Acta Paediatr . 2008;97(3):308316

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6. Cremer RJ, Perryman PW, Richards DH. In-uence of light on the hyperbilirubinaemiaof infants. Lancet . 1958;1(7030):10941097

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12. Seidman DS, Moise J, Ergaz Z, et al. A newblue light-emitting phototherapy device: aprospective randomized controlled study. J Pediatr . 2000;136(6):771774

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15. Tan KL. The nature of the dose-response re-lationship of phototherapy for neonatal hy-perbilirubinemia. J Pediatr . 1977;90(3):448452

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18. Jhrig K, Jhrig D, Meisel P. Dependence of the efciency of phototherapy on plasmabilirubin concentration. Acta Paediatr Scand . 1982;71(2):293299

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Shapiro SM. Clinical report from the pilotUSA Kernicterus Registry (1992 to 2004). J Perinatol . 2009;29(suppl 1):S25S45

20. Hansen TW, Nietsch L, Norman E, et al. Re-versibility of acute intermediate phase bili-rubin encephalopathy. Acta Paediatr . 2009;98(10):16891694

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webstore/webstore.nsf/Artnum_PK/42737.Accessed December 21, 2010

22. Ente G, Klein SW. Hazards of phototherapy. N Engl J Med . 1970;283(10):544545

23. Messner KH, Maisels MJ, Leure-DuPree AE.Phototoxicity to the newborn primate ret-ina. Invest Ophthalmol Vis Sci . 1978;17(2):178182

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25. Paludetto R, Mansi G, Rinaldi P, SaporitoM, De Curtis M, Ciccimarra F. Effects of

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APPENDIX Denition of Grades for Recommendation and Suggestion for Practice

Grade Denition Suggestion for Practice

A This intervention is recommended. There is a high certainty that the net benet is substantial Offer and administer this interventionB This intervention is recommended. There is a moderate certainty that the net benet is

moderate to substantialOffer and administer this intervention

C This intervention is recommended. There may be considerations that support the use of thisintervention in an individual patient. There is a moderate to high certainty that the netbenet is small

Offer and administer this intervention only if other considerations support thisintervention in an individual patient

D This intervention is not recommended. There is a moderate to high certainty that theintervention has no net benet and that the harms outweigh the benets

Discourage use of this intervention

I The current evidence is insufcient to assess the balance of benets against and harms of this intervention. There is a moderate to high certainty that the intervention has no netbenet and that the harms outweigh the benets. Evidence is lacking, of poor quality, orconicting, and the balance of benets and harms cannot be determined

If this intervention is conducted, the patientshould understand the uncertainty about the balance of benets and harms

US Preventive Services Task Force Grade denitions, May, 2008 (available at www.uspreventiveservicestaskforce.org/3rduspstf/ratings.htm) .

http://www.uspreventiveservicestaskforce.org/3rduspstf/ratings.htmhttp://pediatrics.aappublications.org/http://pediatrics.aappublications.org/http://pediatrics.aappublications.org/http://pediatrics.aappublications.org/http://pediatrics.aappublications.org/http://www.uspreventiveservicestaskforce.org/3rduspstf/ratings.htm


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DOI: 10.1542/peds.2011-1494; originally published online September 26, 2011;2011;128;e1046Pediatrics

Vinod K. Bhutani and the Committee on Fetus and NewbornInfant 35 or More Weeks of Gestation

Phototherapy to Prevent Severe Neonatal Hyperbilirubinemia in the Newborn

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