Evaluation of the benefits and efficacy of light emitting diode (LED) device with respect to conventional fluorescent tube phototherapy device in neonatal hyper bilurubenimia in near term and full term neonates

Murmu M.C.1, Das L.2, Suneer C.M.3

1Dr. Mangal Charan Murmu, Assistant Professor, 2Dr. Leena Das, Associate Professor, 3Dr.Suneer C.M., Resident Physician, all authors are affiliated with Department of Pediatrics, S C B Medical College, Cuttack, Odisha, India

Address for Correspondence: Dr. Mangal Charan Murmu, E-mail: mangal74murmu@yahoo.co.in

Abstract

Introduction: Neonatal jaundice is a common, in most cases a benign problem in neonates. About 60% of term and 80% of preterm babies develop jaundice during the first week of life. About 5-10% of all newborns need phototherapy for this commonest morbidity in neonatal life. The commonly used light sources are special blue fluorescent tubes, compact fluorescent tubes and halogen spotlights. In recent years a new type of light source light emitting diodes (LED) has been incorporated into phototherapy. Methodology: Hospital based prospective and observational study.The study was done over a period of two years in SNCU, NICU and Newborn ward, department of paediatrics, S.C.B. Medical College, Cuttack from September2014 to August 2016. Investigation were done in the department of pathology, biochemistry and central laboratory. Results: The duration of phototherapy was shorter in patients who received LED phototherapy than those treated with conventional phototherapy. The children receiving LED phototherapy has less weightloss compared to conventional photo therapy. There is 12% extra loss of weight during phototherapy in children with conventional phototherapy. Rebound hyperbilirubenimia was more in children treated with LED phototherapy.About 12% babies developed rebound hyperbilirubenimia in those treated with LED Phototherapy as compared to 8 % of conventional phototherapy. Side effects are more in conventional phototherapy. Conclusion: LED is safe rescue treatment for severe neonatal hyperbilirubenimia and its implementation reduce the failure of phototherapy and need for exchange transfusion.

Keywords: Phototherapy, Kernicterus,Hyperbilirubinemia

Manuscript received: 18th April 2017, Reviewed: 28th April 2017
Author Corrected: 7th May 2017, Accepted for Publication: 14th May 2017

Introduction

Hyperbilirubenimia is defined as the increase in serum bilirubin level in circulation. Jaundice attributable to physiological immaturity of neonates to handle increased bilirubin production is termed as physiological jaundice. Visible jaundice usually appears between 24 to 72 hours of life. TSB (Total Serum Bilirubin) levels usually rises in term infants to a peak level of 12 to 15 mg/dl by 3 Days of life and than fall. In preterm babies, the peak level occurs on the 3to 7 days of age and TSB can rise over 15mg/dl.Pathological jaundice is said to be present when TSB concentrations are not in physiological jaundice range, which is defined arbitrarily and loosely as more than 5mg/dl on first day, 10mg/dl on second day and 12 -13 mg/dl thereafter in term neonates. Any bilirubin value of 17mg/dl or more should be evaluated for the cause and possible intervention, such as phototherapy [7,8]. About 60% of term and 80% of preterm babies develop jaundice during the first week of life [1,2]. About 5-10% of all newborns need phototherapy for this commonest morbidity in neonatal life [3]. Premature babies have much higher incidence of neonatal jaundice requiring therapeutic intervention more commonly than the term newborns [4]. Although the outcome for the majority is benign, infaints with untreated, severe hyper bilirubenimia(defined as serum bilirubin level>20mg/dl)can develop signs of Acute billirubin encephalopathy (ABE). Management of hyperbillirubenimia includes detection of at risk neonates, investigating the cause of pathological hyperbillirubenimia, deciding the thresholds for starting and stopping treatment and follow-up of neonates with severe hyperbillirubinemia [5].

Common risk factors for pathological unconjugated jaundice include blood group incompatibility, glucose-6-phosphate dehydrogenase enzyme deficiency, prematurity, instrumental delivery and non-optimal breastfeeding. A direct relationship between severe unconjugated hyperbilirubenimia and neurological damage has been demonstrated. Acute bilirubin encephalopathy is caused by the toxic effects of unconjugated bilirubin on the central nervous system. A morbidity which if untreated, may progress rapidly to advanced manifestations such as opisthotonous and seizures. Intervention such as exchange blood transfusion and phototherapy aim at reducing the serum bilirubin in order to prevent bilirubin brain toxicity [9].Understanding the dose response effect and other factor that influence the way light works to lower the bilirubin levels has led to the effective use of phototherapy and has eliminated the need of exchange transfusion in all most all jaundiced infaints [11]. The efficacy of phototherapy depends upon wavelength irradiance, exposed body surface area, distance of photo therapy and duration of exposure. Intensive phototherapy is provided by use of high levels of irradiance in the 430to 490 nm band (usually 30 µW/cm sq/nm or higher) delivered to as much of infant’s body surface area as possible [14]. The commonly used light sources are special blue fluorescent tubes, compact fluorescent tubes and halogen spotlights [13,14].In recent years a new type of light source light emitting diodes (LED) has been incorporated into phototherapy. LEDs are power efficient, portable device with low heat production so that it can be placed very close to the skin of the baby without any apparent untoward effects. They are durable light sources with average life span of 20,000 hours [17]. Blue LEDs have a narrow spectral band of high intensity monochromatic light that overlaps the absorption spectrum of bilirubin [17]. The unique characteristics of LEDs make them attractive light source for an optimal phototherapy unit.

The present study is to evaluate efficacy of LED phototherapy in comparison with conventional phototherapy in the management of neonatal hyperbillirubinemia and to compare its side effects and ability to prevent exchange transfusion, to compare the comfort level of staff during photo therapy.
Aim-To evaluate the benefits and efficacy of light emitting diode (LED) with respect to conventional fluorescent tubes phototherapy device in management of neonatal hyperbilirubinemia in term and near term newborns.
Objectives- To evaluate the benefits of LED phototherapy as compared to conventional photo therapy in decreasing serum total bilirubin level and duration of treatment with unconjugated hyperbilirubinemia during the first 28 days of life.

Sample Size- 200 Newborn babies

Selection of Babies- All the newborn babies who were admitted in the neonatal wards of paediatrics department at S C B Medical College& SVPPGIP, Cuttack, full filling the inclusion criteria were examined & investigated in detail and necessary data was noted in a pre-designed Performa.

Inclusion criteria
1. Gestational age >35 weeks
2. Birth weight >2kg
3. Post natal age less than/equal to 28 days

Exclusion criteria
1. Gestational age <35 weeks
2. Birth weight <2kg
3. Newborns with ABO or Rh incompatibility (Pathological jaundice)
4. Neonates without sepsis & birth asphyxia
5. Babies more than 28 days of life

Materials and Methods

This study is Hospital based prospective and observational study.The study was done over a period of two years in SNCU, NICU andNewborn wardof department of paediatrics, S.C.B. Medical College, Cuttack from September 2014 to August 2016.Investigation were done in the department of pathology, biochemistry and central laboratory .

All the babies were appropriate for gestational age (AGA) and with normal finding on physical examination. Babies with normal blood count and peripheral smear, no evidence of blood group isoimmunisation, negative direct coomb test (DCT), normal reticulocyte count and normal enzyme activities are taken for study.

Out of two hundred newborns, 100 newborns are treated with conventional phototherapy (Group 1). were taken by assessing the values with hour specific Bhutani’s nomogram. Visible icterus was evaluated by using Kramer’s rule. The skin colour of baby was elicited by using Felix Von Luschan skin colour scale. All the neonates were followed till the baby was present in the hospital i.e. recovery or discharged otherwise (LAMA/DAMA/DEATH)

The newborns are placed in open cribs undressed except for diaper and had eyes covered, interrupted only for feeding, cleaning and blood test. In both groups distance of baby from phototherapy unit was matched. Conventional phototherapy was utilised in group 1 at a distance of 40cm. LED device was also kept at distance of 40cm. The conventional fluorescent phototherapy unit we used is NEOTECH, MEDITRIX phototherapy unit. The LED system is BRILLIANCE LED SYSTEM, D REV PHOENIX Obelis s a, Boulevard General wahs 53,1030 brussels.

The irradiance of phototherapy units at surface are measured at the level of face, xiphoid and knees by photoradiometer.(THOR MULTIESTER MOD3620FANEM BRASIL). Laboratory examinations included total and direct serum bilirubin at the time of enrolment, blood groups of the newborn and the mother , blood test for hemolysis , unusually shaped red cell, or evidence of infection and test for G6PD deficiency.Venous sampling for serum bilirubin is done at 8, 24 and 48 hours. The values are compared with transcutaneous bilirubin level which is taken using a DRAGER-JM103 transcutaneous bilirubinometer over the covered area. Axillary body temperature was measured every 4 hours.

The present study is an attempt to evaluate the efficacy of LED Phototherapy with respect to conventional phototherapy and the benifits like preventing exchange transfusion, decreasing side effects and its role in management of neonatal hyperbilirubenimia.

Observation

Table-1: Gestatinal age and sex distribution in our study (n =200)

Gestational age

Boy baby

Girl baby

Total

Late pre term

12

20

32

Term

108

60

168

Total

120

80

200

Out of two hundred newborn 168(84%) were term and remaining were late preterm as shown in table 1. Boy baby were 120 (60%) and girl baby were 80 (40%) with a boy to girl ratio 1.5:1

Table-2: Postnatal age of presentation to hospital and day of onset of jaundice

Day of life

Admission ( no of babies)

Onset of jaundice(no of babies )

Less than 24 hours

nil

nil

24-48 hours

68 (34%)

50(25%)

More than 48 hours

132 (66%)

150 (75%)

The mean age of presentation to hospital 51.89+/- 4.5 hours with a majority 132 (66%) babies brought to the hospital after 48 hrs of post natal life followed by 68 (43%) babies admitted between 24-48 hours as shown in table 2. Most of the babies developed jaundice after 48 hours, 150 cases (75%), 50 cases (25%) developed jaundice between 24-48 hours. There is no case with jaundice developed less than 24 hours.

Table -3: Kramer’s grading at the time of admission

Kramer’s stage

number of babies

III

14

Iv

102

v

84

Total

200

At presentation 102 (51%) babies had Kramer stage IV for jaundice followed by 84(42%) with stage V jaundice and remaining 14 (7%) have stage III jaundice.

Table-4: Demographical, clinical and laboratory characteristics

Parameter

Conventional group

LED Group

Mean gestational age in week

38.76 +/-1.13

38.38+/-1.14

Gestational age range in week

35-41

35-41

Mean weight at initiation of phototherapy in grams

2772+/-227

2719+/-282

Mean weight at stoppage f phototherapy in grams

2610+/-197

2576+/-276

Mean weight loss in grams

161+/-110

142+/-41

Mean post natal age at admission in hours

52.22+/-4.8

51.56+/-4.2

Mean postnatal age at development of jaundice in hours

52.58+/-5.10

52.84+/-3.74

Mean time of initiation of phototherapy in hours

52.58+/-5.10

52.84+/-3.74

Mean initial bilirubin in mg /dl

17.38+/-1.17

18.88+/-1.04

Mean biliribin at 8 hour in mg/dl

16.80+/-1.44

15.06+/-1.73

Mean biliribin at 24 hour in mg/dl

16+/-2.17

14.62+/-1.73

Mean biliribin at 48 hour in mg/dl

14.88+/-3.99

12.48+/-2.80

Mean biliribin at stoppage in mg/dl

12.92+/-3.6

12.26+/-2.84

Mean duration

60.68+/-16.9

50+/-2.58

Fall of bilirubin in mg dl/hr

0.058+/-0.03

0.137+/-0.04

Relative change in bilirubin at 8hour (%/hr)

0.41+/-0.2

1.2+/-0.5

Relative change in bilirubin at 48hour (%/hr)

0.29+/-0.3

0.7+/-0.3

Rebound jaundice in number

8

12

Relative change in bilirubin at 8hour (%/hr)

20

6

Mean irradiance (µW/cm square /nm)

18.04+/-1.40

36.34+/-1.13

Side effect in number

20

12

Comfort Likerts scale

20 %

80%

As shown the table LED over score conventional florescent phototherapy in each and every respect.

Table-5: Gestational age of study group

Gestational age in weeks

TYPE

N

MEAN

(week)

Std. deviation

Std. Error mean

t and p value

LED

100

38.38

1.14

0.101

t=1.67

df=97.99

p=0.098

Conventional

100

38.76

 1.135

0.101

 

In this study we allotted 100 newborn babies to LED group with an average gestational age of 38.38+/- 1.14 weeks and 100 to conventional group with average gestational age of 38.76+/-1.135 weeks. Gestational age is compared by dividing the babies into two groups LED and conventional and independent t test was applied to find out the statistical difference. The test shows gestational age did not have any statistical difference in child with LED and conventional phototheray.

Table- 6: Post natal age of admission

postnatal

Type

N

Mean hours

Std. deviation

Std. Error mean

t and p value

Age

In hours

LED

100

51.56

4.200

0.594

t=0.726

df=95.93

p=0.470

Conventional

100

52.22

4.871

0.689

We allotted 100 newborn babies each into LED and Conventional phototherapy group with LED group having mean post natal age of admission 51.56 +/-4.20 hours and conventional group having mean postnatal age of 52.22+/-4.87 hours. Postnatal age was compared in both the groups and the statistical difference was measured by independent t test. It shows that the postnatal age had no statistical difference in both the age group.

Table-7: Time of initiation, stoppage and duration of phototherapy

Time

LED

Conventional

difference

t and p value

Time of initiation in hours

52.84

52.58

0.260

t=0.290

df =89.95

p=0.772

Time of stoppage in hours

102.84

113.26

10.420

t=4.091

df =54.076

p=0.002

Duration of phototherapy in hours

50

60.68

10.680

t=4.413

df =51.291

 

p=0.001

p=0.001
There is no statistical difference in the time of phototherapy ( t=0.290 , p=0.772) but there is significant statistical difference in the time of stoppage (t=4.091 , p=0.001) and duration ( t=4.313, p=0.001) of phototherapy in both the groups.

Table-8: Fall of bilirubin during phototherapy
    

Hrs of phototherapy

Type

N

Mean

Std. deviation

Std. Error mean

t and p value

Bilirubin at initiation (mg/dl)

LED

100

18.8

1.043

0.147

t=6.748

df=96.614

p=0.081

Conventional

100

17.9

1.176

0.166

Bilirubin at 8hrs (mg/dl)

LED

100

15.06

1.038

0.147

t=1.034

df=89.01

p=0.03

Conventional

100

16.80

1.443

0.204

Bilirubin at 48hrs (mg/dl)

LED

100

12.48

2.808

0.397

t=3.485

df=88.129

p=0.001

Conventional

100

14.88

3.978

0.563

Bilirubin at stoppage (mg/dl)

LED

100

12.26

2.841

0.402

t=4.088

df =92.779

p=0.1

Conventional

100

12.92

3.619

0.512

Fall of bilirubin (mg/dl/hr)

LED

100

0.137160

0.045698

0.006462

 t=9.713

df=91.725

P=0.002

Conventional

100

0.058122

0.034963

0.004944

The mean bilirubin at initiation of phototherapy is 18.8+/- 1.04 mg/dl in LED group and 17.9+/-1.17 mg/dl in conventional group and bilirubin level at 8 hours is 15.06+/-1.04mg/dl in LED group and 16.80+/-1.44mg /dl in conventional group, while the bilirubin at 48 hours is 12.48+/-2.80mg/dl in LED group and 14.88+/-3.97 mg/dl in conventional group. The bilirubin at stoppage is 12.26+/-2.841mg/dl and 12.92+/-3.619mg/dl in both groups. The fall of bilirubin is 0.1371+/-0.0456mg/dl/hour in LED group and 0.0581+/-0.004mg/dl/hr in conventional group. There is no significance difference in the case of bilirubin at initiation and bilirubin at stoppage since the p value is more than 0.05 as seen in the bilirubin at 8 ,48 hours;and the fall of bilirubin shows a definite statistical difference between LED and conventional group (p value<0.05).

Table-9: Irradiance of phototherapy

Irradiance in µW/cm square /nm

 

Type

N

Mean

Std. deviation

Std. Error mean

T and p value

LED

100

36.3460

1.13573

0.1606

t=71.695

df=93.914

p=0.001

CONVENTIONAL

100

18.0400

1.40349

0.1984

The mean iradiance of LED phototherapy unit is 36.35+/-1.13 where as in conventional fluorescent phototherapy unit is by using THOR 3620 Flux meter. Comparing the irradiance of LED phototherapy unit and conventional fluorescence tube phototherapy unit there is a significant statistical difference ( t=71.69, p=0.0001)

Table-10: Weight loss during phototherapy

 

Type

N

Mean

Std. deviation

Std. Error mean

t and p value

Weight at initiation in grams

LED

100

2719

282.642

39.972

t=1.033

df=93.75

p=0.304

Conventional

100

2772

227.713

32.203

Weight at stoppage in grams

LED

100

2576

276.642

39.123

t=0.750

df=92.618

p=0.478

Conventional

100

2611

197.370

27.912

Weight loss in grams

LED

100

142

41.699

5.897

t=1.069

df=90.658

p= 0.06

Conventional

100

161

110.583

15.639

The weight at initiation in LED group and conventional group is 2719+/-282.64 and 2772+/-227.71g respectively. The weight at stoppage is 2576+/-276.64g and 2611+/-197.37g in both groups. Hence the mean weight loss is 141+/-1.699g and 161+/-110.583g in both group respectively. There is no significant difference regarding the weight of the babies during initiation and stoppage of phototherapy groups ( t =1.033 and p= 0.304, t=0.750 and p=0.06). Even the weight loss is more during conventional phototherapy, there is no definite statistical difference.

Table-11: Rebound hyperbilirubinemia
    

Type

N

Rebound

p and t values

LED

100

12

t=0.887

df=94.30

p=0.38

Conventional

100

8

Out of 100 babies treated with LED Phototherapy 12 babies have rebound hyperbilirubinimia as compared to 8 in conventional phototherapy. There is significant between both group since the p value is 0.38.

Table-12: Failure of Phototherapy
    

TYPE

N

Failure

 

p and t value

LED

100

Exchange transfusion

0

t= 2.107

 

df=79.729

 

p=.003

DSPT

6

Conventional

100

Exchange transfusion

4

DSPT

16

There is total number of 20 failure in conventional phototherapy, sixteen of them going for DSPT and four out of them going for exchange transfusion. In LED group there is only six failures all going for DSPT. There is a significant difference in failure of phototherapy between both group.

Table-13:  Side effect & Staff and parental comfort during phototherapy
            

Type

N

Side effect

t and p value

N=200

t and p value

Staff and parental comfort

LED

100

Hyperthermia 0

t= 1.488

 

 

df=88.136

 

p=0.140

160

t= 2.578

df= 76.658

p=0.012

Hypothermia 2

Burns and rash 4

Dehydration 0

Irritability & crying 6

Conventional

100

Hyperthermia 4

40

Hypothermia 0

Burns and rash 5

Dehydration 1

Irritability & crying 10

The LED group total of about twelve babies developed some side effect while in conventional group about twenty babies developed side effects showing p value 0.140. so there is no significant statistical difference. In LED group there is no case of hyperthermia, while 2 babies developed hypothermia (2%). There are no case of dehydration, while four babies developed rash (4%). In conventional group they developed four cases of hyperthermia (4%), five cases of rashes(5%) and one case of dehydration (1%), irritability and excessive crying is more in conventional (10%) than LED (6%).
Out of total 200 staff (nursingstaff and doctors) 160 favoured LED phototherapy. Here we got the p value 0.012 and is statistically significant.

Discussion

Out of 200 newborns included in our study , 68(84%) babies were term and remaining 32(16%) babies were late preterm with baby boy being 120 (60 %) and girl baby 80(40%) and M:F ratio 1.5:1 as shown in table 1 .This might not be true as study includes only term and late pre term babies. Recent review by Cochrane includes both term and preterm babies, which is different from our study. The study conducted by Majid Mohammadizadeh [21]in Iran in 2012 includes only preterm neonate. The average age of gestation in babies treated with LED phototherapy is 38.38+/-1.14 weeks and conventional group is 38.76+/-1.13 weeks. Similar results were observed by other authors [28,29]. Table 2 shows the mean age of presentation to the hospital 51.89+/-4.5 hours with majority 132(66% )babies brought to hospital after48 hours of post natal life followed by 68(38%)babies between 24-48 hours[10,]. The average post natal age of presentation in LED group is 51.56+/-4.871 hours, a study by Martin 2007 have similar results [19,20]. There is significant difference in time of stoppage (t=4.091,p=0.002) and duration of photo therapy ( t =4.431,p=0.001) while comparing LED with conventional group as shown in table -10. The study shows duration of phototherapy with LED is much lower. Similar results were observed by other authors [19,21,22,26].

The mean bilirubin at the time of initiation and stoppage was almost similar in two groups, there by indicating that uniform guidelines was followed for starting and stopping of phototherapy. This is in accordance with Kumar et al [28]. LED phototherapy might be useful in treating severe hyperbilirubenimia and there by preventing its complications [19,20,23,24]. The average irradiance of LED in our study is 36.34+/-1.35µW/cm square /nm which was below reported level according to Tan et al [27].

The rebound hyperbilirubinemia is more in LED as compared to conventional, this is against Belma et al[23], Seidman 2003[23]. The weight loss during phototherapy is more in conventional group (161+/-110gms) than LED group (142+/-41.699gms), this is comparable with Kumar et al 2009[28], uras et al 2009[29].The study shows that LED phototherapy re more efficient in preventing failure of phototherapy and exchange transfusion, which is same as study done by kumar et al 2010[19] and martins 2007[21]. Uras et al 2009 studied that there were no failure of phototherapy in both LED     and conventional group [29]. In our study, in LED group 12 percent children developed any type of side effect against a 20 percent of side effects in babies treated with conventional phototherapy, it is similar to study conducted by Kumar 2010[19] and Martins [21]. In our study which is Likert scale study, out of 200 newborn babies treated with phototherapy about 80% show more comfort with LED phototherapy while only 20% opts for conventional phototherapy. It shows a definite statistical difference since more opting for LED phototherapy [p=0.012].The study is similar with study done by Seidman et al [23,24].

Conclusion

Jaundice usually becomes clinically apparent to parents by zone IV and hence need immediate treatment to prevent kernicterus. This can be achieved by institution of proper proper phototherapy more device. LED phototherapy is more efficacious in bringing down the serum bilirubin level. The rate of fall of bilirubin is more with LED phototherapy unit than conventional fluorescent tube phototherapy unit. The maximum fall of billirubin is during initial phase of phototherapy. LED Phototherapy unit have twice the irradiance of conventional phototherapy unit. LED is safe rescue treatment for severe neonatal hyperbilirubenimia and its implementation reduce the failure of phototherapy and need of exchange transfusion. LED phototherapy device has caused less frequent side effects and there was no acute severe side effects. It produces less heat and dehydration so can be placed very close to the newborn. Moreover LED phototherapy unit provide more nursing comfort as compared to the conventional phototherapy unit. Only draw back with of LED with our study it causes rebound jaundice. Hence LED could be a resourceful technique in view of its efficacy and least side effects and cost effectiveness.

Abbreviations

ABE: Acute bilirubin encephalopathy, NIND: Neurological induced neurological dysfunction, C F T: Compact fluorescent tube, DSPT: Double surface phototherapy, g/dl: gram per deci liter, i.e.: that is, LED: light emitting Diode, Kg: kilogram, LAMA: Left against medical advice, N: Number of cases/observation, NNHB: Neonatal hyper bilirubinemia, S: Serum, T S B: Total serum bilirubin, %: percentage, &: and, µmol/L: Micro mol per litre, µW/cm square /nm: micro watt per centimetre square per nanometer

Funding: Nil, Conflict of interest: None initiated.
Permission from IRB: Yes

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How to cite this article?

Murmu M.C, Das L, Suneer C.M. Evaluation of the benefits and efficacy of light emitting diode (LED) device with respect to conventional fluorescent tube phototherapy device in neonatal hyper bilurubenimia in near term and full term neonates. J PediatrRes.2017;4(05):333-342.doi:10. 17511/ijpr.2017.05.08.