fototERAPI NEONATAL JAUNDICE

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EVIDENCE CENTREEVIDENCE R EPORT

Series 2003: Therapy

Phototherapy in the home for jaundiced neonates.

Simon French


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Centre for Clinical EffectivenessMonash Institute of Health Services ResearchMonash Medical CentreLocked Bag 29Clayton VIC 3168Australia

Telephone: +61 3 9594 7505Fax: +61 3 9594 7552Email: [email protected] (quote author of report)URL: http://www.med.monash.edu.au/healthservices/cce/

December 2003

SUMMARY STATEMENT

Disclaimer – please refer to Appendix 1 for information.

Copyright – please refer to Appendix 1 for information.

Publication of materials – please use the following format when citing this article:

French, S (2003). Phototherapy in the home for jaundiced neonates. (The Centre forClinical Effectiveness), Available: http://www.med.monash.edu.au/healthservices/cce

[Accessed:Access date…]

Form Version – B.2002.01.05.1

Centre for Clinical Effectiveness – Evidence Report 2

mailto:[email protected]://www.med.monash.edu.au/healthservices/cce/http://www.med.monash.edu.au/healthservices/ccehttp://www.med.monash.edu.au/healthservices/ccehttp://www.med.monash.edu.au/healthservices/cce/mailto:[email protected]


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REQUESTIs conducting phototherapy for jaundiced neonates in the home associated with adverseeffects compared to phototherapy conducted in the hospital?

REQUESTED BYMinnesha Yasmine , Resource Midwife, Women’s and Children’s Program, MonashMedical Centre.

SUMMARY OF FINDINGS:• No high quality evidence was located that compares home phototherapy to

hospital phototherapy in neonates with jaundice.

• The evidence located was methodologically flawed, but concluded that homephototherapy was a safe and effective alternative to hospital phototherapy.

METHODOLOGY

Search StrategyThe Centre for Clinical Effectiveness defines the ‘best available evidence’ as that researchwe can identify that is least susceptible to bias.

First, we search for systematic reviews, evidence based clinical practice guidelines andhealth technology assessments. Then we identify diagnostic studies with independent

blind comparison of an appropriate spectrum of consecutive patients, who haveundergone both the diagnostic test and the reference standard. If we identify sound,relevant material of this type, the search stops. Otherwise, our search strategy broadensto include studies that are more prone to bias, less generalisable, or have othermethodologic difficulties. While we cite observational and case series studies, narrativereviews and consensus statements in our reports, we do not critically appraise them.These studies can produce accurate results but they are generally too prone to bias toallow determination of their validity beyond their immediate setting.

Details of Evidence Request

Patients (Subjects): Jaundiced neonates.Intervention: Phototherapy conducted in the home.

Comparator: Phototherapy conducted in the hospital.

Outcomes: Resolution of jaundice, adverse effects, breastfeeding rates,bonding.

Search terms(see Appendix 2 for exact search strategy)

Patient (Subject): Infant, newborn, neonate, jaundice, hyperbilirubinaemia.

Intervention: Phototherapy, biliblanket, UV light, home care services.



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Resources SearchedWe searched the following databases and internet websites for English language articles:

Resource Issue or Access Date

Australasian Medical Index (Informit) 17 November 2003

CINAHL (OVID) 1982 to November Week 1 2003

Cinch (Informit) 17 November 2003

The Cochrane Library (Online) 17 November 2003

EBM Reviews (OVID):

• Cochrane Database of Systematic Reviews 3 rd Quarter, 2003

• Database of Abstracts of Reviews of Effectiveness 3 rd Quarter, 2003

• Cochrane Controlled Trials Register 3 rd Quarter, 2003

Google (Online) 18 November 2003

MEDLINE (OVID) 1966 to October Week 5 2003

National Guideline Clearinghouse 17 November 2003

MEDLINE ® In-Process 17 November 2003

PubMED (Online) 17 November 2003

Refinements, Searching & Reporting Constraints

We applied the following inclusion and exclusion criteria to the articles retrieved:

Inclusion Criteria

• Subjects in study must be neonates with jaundice.

• Study must compare phototherapy conducted in the home to phototherapyconducted in the hospital.

• Outcomes measured must include resolution of jaundice and adverse events.

Exclusion Criteria

• Level IV study, narrative review.

• Article not received by 22 nd December.



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RESULTS: From the resources searched, we identified 40 potentially relevant articles. If it was notclear from the abstract, we obtained the full text of these articles to determine theirrelevance. After examination of the 40 articles, 37 studies were excluded for the reasonsoutlined in Table 1.

Table 1. Reasons for exclusion of studies identified in the search strategy.

Reason for exclusion Number

Case series (Level IV) 10

Narrative reviews, letters and commentaries 19

Incorrect comparator 4

Article not received by 22 nd December 4

Total 37

The 3 articles that met the inclusion criteria were all cohort studies (Table 2). Two wereprospective studies and one was retrospective.

Table 2. Study designs of included articles

Study Design Number included

Systematic reviews or meta-analyses 0

Randomised controlled trials 0

Prospective cohort studies 2

Retrospective cohort studies 1

Total 3

Based on our refinements, searching and reporting constraints we are reasonablyconfident these articles represent the most relevant findings published to date.

Findings

Three studies met the inclusion criteria. All of these studies were conducted in the UnitedStates, two in the Salt Lake City region. All three studies were at least 10 years old. Allthe studies compared home phototherapy to hospital phototherapy.

Overall ResultsFor one study (James 1993), the primary outcome was the rate of mothers that ceasedbreast feeding during the treatment period. The other two studies (Eggert 1985, Slater1984) measured decrease in bilirubin levels as their primary outcome.

In the study by James (1993), a much high proportion of mothers stopped breast feedingin the hospital group than the home group (42% vs 9%, p


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In the two studies that measured daily decrease in bilirubin, there was no significantdifference between those neonates treated at home and those that were treated in thehospital.

In two of the studies, no complications were reported in either group, and in one study(Eggert 1985) six of the mothers (10%) reported only mild complications. In the study

by Slater (1984), one infant treated at home was a considered a treatment failure. Theauthors stated that this case demonstrated an issue of concern with home treatment,questioning whether bilirubin values rise fast enough to produce kernicterus before thenext home visit by the supervising health practitioner occurs.

In all three studies, home treatment took longer. In all studies, home treatment wascheaper.

Research MethodologyTwo of the included studies were prospective comparative studies and the remainingstudy was a retrospective comparative study (James 1994). All of the studies wereconducted in the United States. Each study compared hospital phototherapy to

supervised home phototherapy.

Focused AppraisalAll the studies were observational studies and the investigators had influence over whichgroup patients were allocated to. There are inherent biases in this type of study designfor intervention studies.

None of the studies performed a random allocation of patients to the intervention groups.This is problematic when testing an intervention. Only one of the studies (Slater 1984)described how a subject was allocated to home or hospital phototherapy. There may beother differences between the groups, other than the difference in intervention provided.For example, in the study by James (1993), mothers may have chosen home

phototherapy specifically because they wanted to continue breast feeding, whereas thehospital group mothers may not have wanted to continue breast feeding. Randomisationof neonates to home or hospital phototherapy would reduce this possible bias.

None of the studies blinded the assessor who determined the outcome of the neonates.Blinding increases the validity of a study by removing the possibility that the assessor isinfluenced by the intervention to which the patient is allocated.

The setting for all of the studies was the United States, which may not be generalisableto the Australian setting. Protocols and practices may vary from hospital to hospital andcountry to country.

All the studies employed a small sample size. Only one study (Eggert 1985) was of morethan 100 infants. A small sample size results in decreased generalisability. Also, whenthere is no difference between the groups, as for all three of these studies, it may be thatthe sample was not large enough to detect any difference (Type II Error).

None of the included studies described clear criteria for the diagnosis ofhyperbilirubinemia. This is a problem as it is not possible to know exactly what their casedefinition was. Also, it is not possible to determine a ‘treatment failure’ without anycriteria to go by.



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ConclusionAll three of the included studies concluded that home phototherapy was feasible, safeand effective alternative to hospital phototherapy. However, weaknesses in study designas discussed above necessitate that these conclusions be interpreted with caution. Thereis currently no high level evidence to answer this evidence request. A randomised

controlled trial is required where one group of neonates is allocated to hospitalphototherapy and another is allocated to home phototherapy in order to definitivelyaddress this topic.

EVIDENCE SUMMARIES

FormatEvidence summaries are presented as spreadsheets attached to this report. Eachspreadsheet contains the article citation, details of the study design, patient description,scientific validity of the article, results, pertinent remarks from the study authors and

Centre for Clinical Effectiveness reviewer.



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REFERENCES

ARTICLES CRITICALLY APPRAISED FOR THIS REPORTJames JM, Williams SD & Osborn LM (1993). Discontinuation of breast-feeding infrequentamong jaundiced neonates treated at home. Pediatrics 92(1): 153-5.

Eggert LD, Pollary RA, Folland DS & Jung AL (1985). Home phototherapy treatment ofneonatal jaundice. Pediatrics 76(4): 579-84.

Slater L & Brewer MF (1984). Home versus hospital phototherapy for term infants withhyperbilirubinemia: a comparative study. Pediatrics 73(4): 515-9.

ARTICLES NOT CRITICALLY APPRAISED

Case studies (Level IV)Jackson CL, Tudehope D, Willis L, Law T & Venz J (2000). Home phototherapy forneonatal jaundice--technology and teamwork meeting consumer and service need.Australian Health Review 23(2):162-8.

Hamelin K & Seshia M (1998). Focus on quality. Home phototherapy for uncomplicatedneonatal jaundice. Canadian Nurse 94(1): 39-40.

Madlon-Kay DJ (1998). Evaluation and management of newborn jaundice by midwestfamily physicians. Journal of Family Practice 47(6): 461-4.

Freeman KG (1997). Home phototherapy: shedding light on commencement, newbornvariations, and outcomes. University of Maryland at Baltimore (PhD thesis).

Meropol SB, Luberti AA, De JAR & Weiss JC (1993). Home phototherapy: use andattitudes among community pediatricians. Pediatrics 91(1): 97-100.

Kirgis CA, Solon JF & McNeal C (1987). Nursing care of newborns withhyperbilirubinemia. Pediatric Nursing Forum 2(1): 3-8.

Dortch E & Spottiswoode P (1986). New light on phototherapy: home use. NeonatalNetwork Journal of Neonatal Nursing 4(4): 30-4.

Grabert BE, Wardwell C & Harburg SK (1986). Home phototherapy. An alternative toprolonged hospitalization of the full-term, well newborn. Clinical Pediatrics 25(6): 291-4.

Rogerson AG, Grossman ER, Gruber HS, Boynton RC & Cuthbertson JG (1986). 14 yearsof experience with home phototherapy. Clinical Pediatrics 25(6): 296-9.

Ellis J (1985). Home phototherapy for newborn jaundice. Birth 12(3): 15-7.

Narrative reviews, letters and commentariesRichmond G, Brown M & Wagstaff P (2003). Using a home care model to monitor bilirubinlevels in early discharged infants. Topics in Health Information Management 24(1): 39-41.

Melton K & Akinbi HT (1999). Neonatal jaundice. Strategies to reduce bilirubin-inducedcomplications. Postgraduate Medicine 106(6): 167-8.

Woo EK (1998). Biliblanket phototherapy light. Nursing 28(8): 79.

Sater KJ (1995). Color me yellow: caring for the infant with hyperbilirubinemia. Journalof Intravenous Nursing 18(6): 317-25.

Poland RL (1993). Home phototherapy: not seeing the light. Pediatrics 91(1): 147.

Murphy BN & Welch R (1992). Home phototherapy for the jaundiced full-term newborn.Journal of Home Health Care Practice 5(1): 26-33.



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Dyk J (1990). Home phototherapy: reliable equipment, family education assure qualitytreatment. Continuing Care 9(9): 44-6.

Fuller J (1990). Home phototherapy. Caring 9(12): 8-11.

Ludwig MA (1990). Phototherapy in the home setting. Journal of Pediatric Health Care4(6): 304-8.

Rose BS (1990). Phototherapy: all wrapped up? Pediatric Nursing 16(1): 57-8.

Savinetti-Rose B, Kempfer-Kline RE & Mabry CM (1990). Home phototherapy with thefiberoptic blanket. The nurse's role in caring for newborns and their caregivers. Journal ofPerinatology 10(4): 435-8.

Greenwald JL (1988). Hyperbilirubinemia in otherwise healthy infants. American FamilyPhysician 38(6): 151-8.

Shibley B (1988). Now newborns can stay home for phototherapy. RN 51(2): 69-71.

Grabert BE (1986). Home phototherapy recommendations questioned. Pediatrics 78(2):373-4.

Hartsell MB (1986). Home phototherapy. Journal of Pediatric Nursing 1(4): 282-3.Sapala S & Belkengren R (1986). Pediatric management problems (neonatal jaundice).Pediatric Nursing 12(4): 301.

Anonymous (1985). American Academy of Pediatrics. Committee on Fetus and Newborn.Home phototherapy. Pediatrics 76(1): 136-7.

DeLoache WR (1985). Stop home phototherapy. Pediatrics 75(5): 987-8.

Roeder BJ & Williams DN (1985). Diagnosis-specific home care. The Park Nicollet model.Postgraduate Medicine 77(2): 79-81.

Incorrect comparator

George P & Lynch M (1994). Ohmeda Biliblanket vs Wallaby Phototherapy System for thereduction of bilirubin levels in the home-care setting. Clinical Pediatrics 33(3): 178-80.

Schuman AJ & Karush G (1992). Fiberoptic vs conventional home phototherapy forneonatal hyperbilirubinemia. Clinical Pediatrics 31(6): 345-52.

Woodall D & Karas JG (1992). A new light on jaundice. A pilot study. Clinical Pediatrics31(6): 353-6.

Van Enk A & de Leeuw R (1987). Phototherapy: the hospital as risk factor. British MedicalJournal Clinical Research Ed 294(6574): 747-9.

Article not received by 22 nd December

Armany K & Egan E (1998). Bili babies bond at home. Nursing Spectrum (New EnglandEdition) 2(19): 13.

Reece E & Iverson LJ (1989). Phototherapy for treatment of neonatal hyperbilirubinemia.Journal of Home Health Care Practice 1(2): 46-54.

Heiser CA (1987). Home phototherapy. Pediatric Nursing 13(6): 425-7.

Parlett CH & Spitzer A (1986). Home phototherapy: keeping baby home. Caring 5(11):56-60



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OUR COMMENTS:Opportunity for bias, weaknessand strength

Opportunity for bias:• No randomisation• Reason why newborns were allocated to the different

treatment groups not explained – may be that motherschose home phototherapy because they wanted to performbreast feeding, therefore bias in primary outcomemeasure.

Weakness/es:• Retrospective• Small sample• Hyperbilirubinaemia not defined

Opportunity for bias:• No randomisa• Reason why n

treatment groWeakness/es:

• Small sample• Treatment me• No blinding o• Hyperbilirub

Centre for Clinical Effectiveness – Evidence Report


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EXPLANATION OF TERMINOLOGY USED IN SPREADSHEET

Level of evidence: A hierarchy of study evidence that indicates the degree to which bias hasbeen eliminated in the study design.

Intervention: A therapeutic procedure such as treatment with a pharmaceutical agent,surgery, a dietary supplement, a dietary change or psychotherapy.

Randomisation: A process of allocating participants to treatment or control group within acontrolled trial by using a random mechanism, such as coin toss, random number table orcomputer-generated random numbers. Study subjects have an equal chance of being allocatedto an intervention or control group; thus, the two groups are comparable. Randomisationensures that the results are not biased by the selection of particular types of patients toreceive a specific therapy.

Blinding: Blinding or masking is a process used in epidemiological studies and clinical trials inwhich the observers and the subjects have no knowledge as to which treatment groupssubjects are assigned. It is undertaken in order to minimise bias occurring in patient responseand outcome measurement.

All patients accounted for: Once patients are randomly allocated to a specific group andwithdraw before study conclusion, they have to be accounted for in order to ensure thatpatients withdrawing from the study are not significantly different from those continuing in thestudy. The final analysis should be conducted on an intention-to-treat basis, which includes theresults of withdrawn patients in the analysis.

Patients treated equally: To be able to attribute any difference in the observed outcome tothe intervention, study patients need to be treated equally in every way except for theintervention being evaluated.

Similar groups: Baseline characteristics of patients that are also likely to affect results shouldbe evenly distributed between the intervention and control groups. Following properrandomisation, patients’ attributes would be expected to be equally distributed betweengroups.

Validity:

- Of measurement: an expression of the degree to which a measurement measures what itpurports to measure; it includes construct and content validity.

- Of study: the degree to which the inferences drawn from the study are warranted whenaccount is taken of the study methods, the representativeness of the study sample, and thenature of the population from which it is drawn (internal and external validity, applicability,generalisability).

Potential for bias: Bias is a systematic deviation of a measurement from the ‘true’ valueleading to either an over (or under) estimation of the treatment effect. Bias can originate frommany different sources (including allocation of patients, measurement, interpretation,

publication and review of data).

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APPENDIX 1

Copyright© This publication is the copyright of Southern Health. Other than for the purposes andsubject to the conditions prescribed under the Copyright Act 1968 as amended, no part of this

publication may, in any form or by any means (electric, mechanical, microcopying,photocopying, recording or otherwise), be reproduced, stored in a retrieval system ortransmitted without prior written permission. Inquiries should be addressed to Centre forClinical Effectiveness.

DisclaimerThe information in this report is a summary of that available and is primarily designed to givereaders a starting point to consider currently available research evidence. Whilst appreciablecare has been taken in the preparation of the materials included in this publication, the authorsand Southern Health do not warrant the accuracy of this document and deny anyrepresentation, implied or expressed, concerning the efficacy, appropriateness or suitability ofany treatment or product. In view of the possibility of human error or advances of medicalknowledge the authors and Southern Health cannot and do not warrant that the informationcontained in these pages is in every aspect accurate or complete. Accordingly, they are notand will not be held responsible or liable for any errors of omissions that may be found in thispublication. You are therefore encouraged to consult other sources in order to confirm theinformation contained in this publication and, in the event that medical treatment is required,to take professional expert advice from a legally qualified and appropriately experiencedmedical practitioner.

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APPENDIX 2

Search strategy (only MEDLINE search is shown)

Search terms for MEDLINE

1 Infant, Newborn/

2 (neonate or newborn).mp.

3 infant.tw.

4 Or/1-3

5 jaundice$.mp. or JAUNDICE/ or JAUNDICE, NEONATAL/

6 Hyperbilirubinemia/ or Bilirubin/ or bilirubinaemia.mp.

7 5 or 6

8 Home Care Services, Hospital-Based/ Or Home Care Agencies/ OrAccidents, Home/ Or Home.mp. Or Home Nursing/ Or Home Care

Services/9 (phototherapy adj4 home).tw.

10 biliblanket or uv light.tw.

11 ((ultraviolet or uv) adj light).tw.

12 Or/8-10

13 4 and 7 and 11

14 limit 11 to (human and english language)

Similar search terms, appropriately translated, were used in other databases.

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