phototherapy rather than replace it The present trial hasmanner1Slu - PDF document

phototherapy rather than replace it. The present trial hasmanner.1.Slusher TM, Olusanya BO, Vreman HJ, Brealey AM,2.Harrison S, Nowak M, Devine S, Saunders V, Smith A,IMS, BHU, Varanasi, India.2030 through the recently launched India Newborn ActionPlan – the Indian version of the Every Newborn ActionPlan – at a global level. However, there is a huge distancein Indian conditions as factors such as the differences insunlight during different times of the year can affect thestudy’s outcomes. There are hardly any community-basedIndia. This leads to difficulty in priority setting of this issueunder the RMNCH+A strategy. The researchers haveHowever, it will require trained health workers to carryon this initiative successfully. Public health is aboutbehavior change. Ensuring an effective communitystrategies will be required to make this approach effective.Community-based efficacy and feasibility studies inthousands of children suffering from neonatal Copyright of Indian Pediatrics 2015 For personal use only. Not for bulk copying or unauthorized posting to listserv/websites. 5.Slusher TM, Olusanya BO, Vreman HJ, Wong RJ, Brearley6.Slusher TM, Vreman HJ, Olusanya BO, Wong RJ, Brearley7.Olusanya BO, Imam ZO, Mabogunje CA, Emokpae AA,8.The Cochrane Collaboration’s Tool for Assessing Risk of9.Salih FM. Can sunlight replace therapy units in the10.Weather Statistics for Lagos (Nigeria). Available from:11.Brandão DC, Draque CM, Sañudo A, de Gusmão Filho FA,12.Mohammadizadeh M, Eliadarani FK, Badiei Z. Is the light-13.Tridente A, De Luca D. Efficacy of light-emitting diode14.American Academy of Pediatrics Subcommittee on L MATHEWPGIMER, Chandigarh, India.dr.joseph.l.mathew@gmail.comlower serum bilirubin levels to safe limits. Althoughsettings at affordable costs, the performance of these unitsleaves much to be desired due to low irradiance (energyoutput) or erratic electric supply. Due to this, manyIn this randomized controlled trial (RCT), Slusher,,phototherap

y for the treatment of neonatalhyperbilirubinemia in term and late-preterm newborns in aNigerian hospital. Authors found filtered sunlight aseffective as conventional phototherapy for the treatmentHowever, no newborn was withdrawn from the study forreasons of safety. Interestingly, authors found much higheradvocate its use due to doubtful efficacy and safetyultraviolet radiation [2]. There are also issues ofweather, and its use during winter months when the risk ofhypothermia is high. The present study has refuted some ofequally effective and safe. The authors used special filmlight. Unlike conventional phototherapy, where a newbornrequires separation from mother to receive phototherapy,filtered sunlight has the advantage of maintaining mother-infant interaction with all its attendant benefits, if a largeenough canopy is used to accommodate the mother-newborn dyad. This is a low cost technology and has otheruse of energy source which is essentially free, and also eco-friendly. By virtue of its nature, filtered sunlight cannot beneeded to assess its impact in other settings. A limitation oflevels below 15 mg/dL. Whether filtered sunlight will beequally effective at higher bilirubin values or rapidly risingbilirubin levels needs to be studied further. At highThis occurred in 13% of newborns in present trial. Thusconventional phototherapy is not going to disappear. The Copyright of Indian Pediatrics 2015 For personal use only. Not for bulk copying or unauthorized posting to listserv/websites. would create a spurious impression of greater efficacy inficacy inThis ‘spurious’ superiority is itself doubtful because therewas overlap between the 95% confidence intervals,suggesting comparable effects.fects.measured, there was greater incidence of hyper- andof counter measures. This suggests that routine clinical usefor adverse effects and facilities to correct these. This mayA finding that was not sufficiently emphasized is thatphototherapy after daylight hours [3]. Th

is occurredbilirubin than the standard guideline of the AmericanAcademy of Pediatrics [3,14]. This has two importanta larger proportion of infants. Second, the observationand resources to manage sick neonates. This practicallydescribed above. A minor but potentially important pointthis trial. The intention was to measure irradiance oncereported. We would also expect 1876 readings in the268 days) whereas 2959 are reported. These deviationsHow would mothers respond to offering their babiespotential harmful effects of ultraviolet and infra-redradiation. The authors’ previous study [7] suggested a highfive point Likert scale. However in the survey, motherssunlight in particular.well as the presence of backup phototherapy units. ThisThisof ambient sunshine in most parts of India, during most ofthe year; and the potential for constructing filtered sunlighttents at low cost. The issues that could preclude direct This RCT suggests that filtered sunlightmild to moderate neonatal jaundice in terms of efficacyand safety, in the presence of adequate facilities for backupphototherapy and intensive monitoring. These effects wereconventional phototherapy. There are severalviable alternative to conventional phototherapy.1.Bhutani VK. Committee on Fetus and Newborn; American2.Subramanian S, Sankar MJ, Deorari AK, Velpandian T,3.Slusher TM, Olusanya BO, Vreman HJ, Brearley AM,4.Vreman HJ, Slusher TM, Wong RJ, Schulz S, Olusanya Copyright of Indian Pediatrics 2015 For personal use only. Not for bulk copying or unauthorized posting to listserv/websites. beneficial effect of filtered sunlight. This could beexpected to bias the investigators towards the inter-refinements in their study. First, this RCT was designed asin-vitroevidence suggesting superiority of sunlight [9]. Theefficacy (92%) with filtered sunlight. These observationsdifference in efficacy does not automatically mean that thetwo arms have equivalent efficacy. Therefore, in such asetting where an effective treatment (pho

totherapy) is thecomparison), is appropriate. To achieve this, it is requiredto demonstrate that the 95% CI of the treatment effects infor efficacy and 5% for safety in this trial). This generallynecessitates a larger sample size than conventionalefficacy during two months of the year. In general, thedifferent from the other months [10]; however these areone-third of the days. Naturally, a twelve month period ofthe effect of ambient climatic conditions.Despite high overall efficacy (over 90% as per thelower than in other trials of phototherapy [11-13]. Ofcourse, it may not be appropriate to compare efficacymeasurement. The importance of this is that a less-than-. MSequence generationBlock randomization method with variable block sizes (2-10) was used.UnclearAllocation concealmentAllocation was made using serially numbered slips placed in opaque sealedAdequateenvelopes. These were prepared off-site and opened in sequence after efficacyor safety (development of hyper- or hypothermia, dehydration or sunburn).Incomplete outcome dataA total of 447 infants were randomized; 224 in the intervention arm andUncleartreatment; 11 in the intervention arm and 3 in the comparison arm. Thereafter18 and 13 infants respectively could not be evaluated for efficacy suggestingflow chart. Although reasons for attrition are clearly described and appear. This appears to be aremarkable coincidence. The number of randomized infants included in thesafety analysis is unclear. Data analysis is reported to be intention-to-treat.Selective outcome reportingAll outcomes planned a priori have been reportedOther sources of biasNo obvious sources of bias are evident. Copyright of Indian Pediatrics 2015 For personal use only. Not for bulk copying or unauthorized posting to listserv/websites. INDIAN PEDIATRICS1075VOLUME 52__DECEMBER 15, 2015 Filtered Sunlight for Treatment of Neonatal HyperbilirubinemiaITATION Slusher TM, Olusanya BO, Vreman HJ, Brearley AM, Vaucher YE, Lund TC, A randomizedtrial o

f phototherapy with filtered sunlight in African neonates. N Engl J Med. 2015;373:1115-24.DITOR JJJJOOOOUUUURRRRNNNNAAAAL CL CL CL CLLLLUUUUBBBB preterm neonates. The primary end point was efficacy,phototherapy. Authors pre-specified a non-inferioritymargin of 10% for the difference in efficacy rates betweengroups. The need for an exchange transfusion was asecondary end point. Safety, which was defined as thephototherapy. Filtered sunlight was efficacious on 93% of90% for conventional phototherapy, and had a highertransfusion. Authors concluded that filtered sunlight wasEvidence-based Medicine Viewpointused, other issues for effective phototherapy include mean(and not only peak) irradiance, rate of irradiance decay,,This publication [3] reports a non-inferiorityrandomized controlled trial (RCT) comparing filteredsunlight (Intervention) versus conventional photo-therapy(Comparison) in infants with mild to moderate neonatalhyperbilirubinemia (Population) in terms of efficacy andsafety (Outcomes). The authors justified this trial on thepractical difficulties with delivering appropriateprevious research experiments with filtered sunlight. Thesupply, and need to measure irradiance periodically toensure efficacious delivery. These can be challenging inPrior to the RCT, the investigators demonstrated the(blue light) while restricting ultraviolet A and infraredwavelengths [4]. They then published a protocol [5] fortherapy in near-term neonates -term neonates that filtered sunlight was safe and efficacious in suchperiods of omission on account of hyper- or hypothermia.Simultaneously, they also published data from a survey of, they also published data from a survey offor understanding and appraising this RCT [3].Critical appraisal: Tableablehave a high risk of bias. This is mostly because of unclearThe latter could have been relatively easy for the efficacy Copyright of Indian Pediatrics 2015 For personal use only. Not for bulk copying or unauthorized posting to listserv/websites