|Year : 2017 | Volume
| Issue : 2 | Page : 99-102
Efficacy of different types of phototherapy units on neonatal hyperbilirubinemia
Krishna M Adhikari1, Sheila S Mathai2, Sathya M Moorthy3, Naveen Chawla4, Sandeep Dhingra1
1 Department of Pediatrics, Armed Forces Medical College, Pune, India
2 Director, INM, Mumbai, Maharashtra, India
3 Executive Officer, INHS Asvini, Mumbai, Maharashtra, India
4 Department of Pediatrics, SRM University Medical College, Chennai, Tamil Nadu, India
|Date of Web Publication||13-Feb-2018|
Dr. Sandeep Dhingra
Department of Pediatrics, Armed Forces Medical College, Pune - 411 040, Maharashtra
Source of Support: None, Conflict of Interest: None
Context: Phototherapy is the mainstay of treatment for about 3% of neonates in India who develop significant jaundice in phototherapy range. New devices have been introduced in the market over the past few years. Aims: To compare the efficacy of three types of phototherapy machines, namely Blue and White, Compact Fluorescent Lamp, and Light Emitting Diode type. Settings and Design: A non-randomized prospective interventional study conducted in a tertiary care hospital of Western India. Material and Methods: Ninety neonates with phototherapy range hyperbilirubinemia were assigned into three groups of 30 neonates each to receive phototherapy using one of the three types of phototherapy machines. Need for exchange transfusion, total serum bilirubin (TSB) at 24 hours post-phototherapy and side effect profile were recorded. Decision to stop phototherapy was based on acceptable reduction of serum bilirubin to below phototherapy range. Statistical analysis used: Medcalc® Version 220.127.116.11 Software was utilised. Comparison of mean TSB was done using one way ANOVA. P-value of <0.05 was considered significant. Results: Baseline parameters, TSB at 24 hour post-phototherapy and at the point of stopping phototherapy in the three groups was not significantly different. None of the babies required exchange transfusion or stopping of therapy. Transient rash was the most commonly observed side effect. Conclusions: The three types of phototherapy equipment studied were comparable in efficacy as measured by need for exchange transfusion and mean TSB values at 24 hrs post-phototherapy. The side effect profile was similar and was not significant enough to stop phototherapy.
Keywords: Hyperbilirubinemia, Phototherapy, Newborn jaundice
|How to cite this article:|
Adhikari KM, Mathai SS, Moorthy SM, Chawla N, Dhingra S. Efficacy of different types of phototherapy units on neonatal hyperbilirubinemia. J Mar Med Soc 2017;19:99-102
| Introduction|| |
More than half of normal newborns present with clinical jaundice sometime during the 1st week of life. About 3% of all hospital-born babies in India develop significant jaundice, with total serum bilirubin (TSB) levels more than 15 mg/dl. Majority of them have unconjugated hyperbilirubinemia and are otherwise healthy. They need to be monitored closely because bilirubin is potentially toxic to the central nervous system and can lead to bilirubin encephalopathy and subsequently kernicterus, with devastating, permanent neurodevelopmental handicaps. Fortunately, current interventions make such severe sequelae rare.
Phototherapy is a useful method for treating neonatal hyperbilirubinemia because it is easily available and devoid of complications of double volume exchange transfusions. The efficacy of phototherapy depends on the irradiance, the wavelength of the light used and the surface area exposed. Hospital-based studies in the United States have shown that 5–40 infants per 1000 term and late-preterm infants receive phototherapy before discharge from the nursery and that an equal number are readmitted for phototherapy after discharge.,,, Over the last 2 decades, there has been a constant endeavor to develop ways to increase the efficacy of phototherapy and at the same time reduce the side effects and disadvantages to nursing personnel. Compact fluorescent lamp (CFL) and light-emitting diode (LED) phototherapy units have been available in the Indian market for the last few years while the traditional phototherapy machines using special blue standard length tube lights have been available for many decades. We conducted this study to test the efficacy of various phototherapy units used in our Neonatal Intensive Care Unit (NICU).
| Subjects and Methods|| |
This study was carried out in a tertiary care hospital of Maharashtra. It was an interventional study in which 3 groups of neonates with hyperbilirubinemia were assigned sequentially to different types of phototherapy machines for treatment. Ethical clearance for the study was taken from the Institutional Ethics Committee. A convenience sample of 90 babies was selected, based on the workload related to phototherapy in the hospital where the study was carried out. The study population comprised of neonates with hyperbilirubinemia in phototherapy range admitted or detained in a tertiary care NICU setup. All neonates with indirect hyperbilirubinemia in phototherapy range requiring phototherapy as per AAP guidelines , were included in this study. Exclusion criteria included birth weight <2000 g, gestational age <35 weeks, babies with direct hyperbilirubinemia defined as serum conjugated bilirubin level more than 20% of total bilirubin, sick babies, babies on intravenous fluids/medications and birth injuries (large cephalhematoma, fractures).
The study group consisted of 90 consecutive babies with hyperbilirubinemia fulfilling the inclusion criteria. They were divided into 03 groups according to the mode of phototherapy to which they were assigned. Thirty neonates were assigned to each mode of phototherapy viz. Blue-White Standard Length Tubelight Phototherapy (B&W), CFL phototherapy, and LED phototherapy. B&W phototherapy machine was manufactured by Meditrin instruments, India and had 4 blue and 2 white tube lights (TL 20W/52BB ®, Phillips India). CFL and LED phototherapy machines were manufactured by Zeal Medical, India.
As only one machine each was available under the three categories, namely, Blue–White, CFL, and LED, babies were allocated to the mode of therapy sequentially based on the availability of the machine at the beginning of therapy. For all the babies, detailed antenatal and perinatal history were recorded. Birth history, weight, gestational age, sex, mode of delivery, and age at the start of phototherapy in hours of life were recorded. Need for phototherapy in babies with clinically significant jaundice (Kramer's score) was decided after estimation of total bilirubin by transcutaneous bilirubin (TcB) measurement using JH20-1A transcutaneous jaundice meter marketed by Meditrin India, which was reconfirmed by laboratory values sent simultaneously at the beginning of therapy. Bilirubin estimation in the laboratory was done using automatic analyzer model Dimension ® EXL ™ 200, manufactured by Siemens, Germany. Parents were counseled regarding the need for phototherapy and the method being used based on criteria developed by AAP.,
Repeat measurements while on phototherapy for monitoring the response to treatment was carried out by using non-invasive transcutaneous bilirubinometer every 6 h and minimally invasive micro-bilirubinometer (Twin Beam Micro-bilimeter, Ginevri, Italy) 12 hourly. Reticulocyte count, peripheral smear for evidence of hemolysis, serum albumin levels, blood group of the baby if the mother was Rh negative or O +ve (for ABO incompatibility), Glucose-6-phosphate dehydrogenase (G6PD) deficiency, direct coomb's test (DCT), etc., were done as per the clinical situation.
During phototherapy, TcB reading was taken on two predefined areas, one each on forehead and chest (over 2nd intercostal space) which were covered with carbon patch. The mean was taken for calibration against the standard chart provided by the manufacturer. The Fluxmeter measurements (equipment provided by Meditrin, India) were taken at the level of the baby at three different points. Flux delivered was taken as average of values recorded 12 hourly from the three points. The decision to stop phototherapy was based on bilirubin level falling in the nonphototherapy range as per AAP charts , based on TcB measurements which was corroborated by laboratory measurements.
The primary outcome measured was need for exchange transfusion. Secondary outcomes studied were mean serum bilirubin values at 24 h of phototherapy, mean serum bilirubin value at the point of decision to stop (end of phototherapy), and side effect profile.
Statistical analysis was done using by Medcalc®, Ostend, Belgium. One-way ANOVA was used for comparison of mean between the groups. The difference between two mean values was analyzed using Student's t-test. The significance is taken as P < 0.05.
| Results|| |
There was no significant difference between the three groups of babies with respect to birth weight, gestational age, gender distribution and hemoglobin at initiation of phototherapy (one-way ANOVA, P > 0.05). Age at initiation of phototherapy (hrs of life) was also not significantly different among the three groups (one-way ANOVA, P > 0.05). Duration of phototherapy given also did not differ significantly between the groups (one-way ANOVA, P > 0.05).
Mean flux delivered by the CFL and B and W therapy unit was significantly higher in comparison to that delivered by LED group (P <0.005). However, it is pertinent to mention that all three devices delivered flux in the intensive range (>30 μW/nm/cm 2) [Table 1].
|Table 1: Summary statistics of patient characteristics and comparison between groups|
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When mean bilirubin value was compared between the three groups at the initiation of phototherapy, no significant difference in the value was observed. This applies to the measurement of TcB, TSB by laboratory as well as by microbilirubinometer (one-way ANOVA, P > 0.05). The mean value of total bilirubin obtained after 24 h in all the three groups was not significantly different (one-way ANOVA, P > 0.05). Likewise, there was no significant difference in the mean bilirubin value at the point of decision to stop phototherapy (end of therapy) between the three groups (one-way ANOVA, P > 0.05) [Table 2].
|Table 2: Summary statistics and analysis of serum bilirubin values among three groups|
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None of the babies in the three groups required exchange transfusion, and all the babies were successfully treated with one of these devices and discharged. Side effect profile noted among the babies was minor and transient and did not necessitate stopping of therapy. Side effect profile noted is given in [Table 3].
| Discussion|| |
Phototherapy has been evaluated in a number of randomized trials conducted from the 1960s through the early 1990s., Although these trials helped to establish the efficacy of phototherapy, fewer studies have been done on the relatively higher light doses used today. There are various phototherapy light sources used in routine clinical practice with manufacturers claiming better efficacy with the newer lights such as CFL, LED, etc. If availability is not the limiting factor, then the most effective light source with least side effects would be preferable for babies with significant hyperbilirubinemia. With this fact in mind, the present study was undertaken to compare the efficacy of different phototherapy devices.
A few babies in each group were given treatment for bilirubin in phototherapy range after initial discharge from the postnatal ward or NICU. This is not surprising given the present trend of early discharge of babies to home. Comprehensive postdischarge follow-up for all the babies is provided at the hospital where the study was carried out, thus picking up cases with hyperbilirubinemia requiring phototherapy.
The mean flux delivered by all 3 phototherapy units was much above the values defined as intensive therapy. Flux delivered by B&W equipment and CFL device was significantly higher than the LED device. However, this did not lead to a significant difference in the duration of phototherapy or level of bilirubin at 24 h and at the end of phototherapy. A study by Chang et al. showed that high intensity LED device was much more effective than conventional phototherapy. However, Cochrane review done in 2011 comparing 6 studies did not establish increased efficacy of LED device over other modes of phototherapy.
The primary outcome measure of the study was the need for exchange transfusion. The fact that no baby required exchange transfusion in this study irrespective of equipment used is an indicator of similar efficacy of all equipment in the treatment of neonatal hyperbilirubinemia. It is not prudent to comment on the superiority of one equipment over the other given the small sample size of the present study. The American Academy of Pediatrics, currently recommends special blue fluorescent lamps or LED lights as these have been found to be effective in various clinical studies.,
Studies have shown that, when phototherapy was withheld, 36% of the infants with birthweight <1500 g required exchange transfusions. When phototherapy was used, 2 of 833 such babies required exchange transfusions. Although the findings of these studies are limited to low birth weight babies, no exchange transfusion during the entire study period in the present study is a testimony to the efficacy of phototherapy for control of hyperbilirubinemia, irrespective of the type of equipment used. However, adequate care needs to be instituted to ensure delivery of constant and effective irradiance with frequent clinical and noninvasive monitoring of bilirubin while using this equipment.
Laboratory assessment of serum bilirubin values was obtained at initiation and end of phototherapy. Noninvasive TcB was carried out while monitoring the effect of phototherapy. TcB can give reliable results before the initiation of phototherapy. However, the results cannot be relied on once the skin surface is exposed to few hours of irradiance. Various modalities such as measuring the values from covered areas of skin behind the eye pad are recommended to increase the reliability of the assay. In our study, the transcutaneous values were taken from a small patch of unexposed area covered with a black carbon paper on the forehead and at the second left intercostal space. The initial and the final bilirubin value before the cessation of phototherapy were comparable with no significant difference in serum bilirubin between laboratory and TcB values among all the three group of babies. TcB being noninvasive was useful for monitoring bilirubin while on phototherapy and the comparable laboratory values were supportive.
The adverse effect profile noted in the babies was similar in all the three groups with rash being the predominant side effect. All rashes were self-limiting and disappeared spontaneously, though it caused significant concerns in the mother. Periodic reinforcement to mothers and staff by the residents about the necessity of regular temperature monitoring and timely feeding of babies while on phototherapy reduced the incidence of both hyperthermia and dehydration. Since the study excluded babies with birthweight <2000 g and sick babies, it was possible to ensure exclusive breastfeeding for all the neonates in the study.
Certain shortcomings of the present study need to be considered for improvement during subsequent studies. We resorted to a sample size of 30 in each group as the center where the study was conducted had an annual load of about 80–90 babies requiring phototherapy. Sample size calculation using a statistical parameter could have improved external validity of our findings. More number of phototherapy equipment under each category could have ensured effective randomization. Measurement of rate of fall of bilirubin could have strengthened the study further. Larger multicentric studies are recommended with randomization before concrete recommendations on the superiority of one phototherapy device over the other are offered.
| Conclusion|| |
There was no difference in the efficacy of the three devices used for administering phototherapy as estimated using the primary outcome. The mean change in bilirubin level at 24 h as well as at the end of therapy did not show any significant difference between the 3 modes of phototherapy. Ensuring effective flux, adequate feeding, and constant monitoring, all the 3 phototherapy devices could be used to treat hyperbilirubinemia without significant adverse effects. Larger trials are needed to offer recommendations on advantages and superiority of one equipment over the other.
Financial support and sponsorship
This study was financially supported by Office of DGAFMS as an AFMRC project.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]
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