Synopsis Phototherapy in Jaunic

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COMPARISON OF CONTINUOUS WITH INTERMITTENT PHOTOTHERAPY

IN THE TREATMENT OF NEONATAL JAUNDICE


Introduction

Yellow discoloration of the skin and sclera that results from accumulation of bilirubin in the skin
and mucous membrane was named as jaundice. It is the commonest clinical condition requiring
medical attention in the newborn babies1. It affects 60% of term and 80% of preterm infants. In
our area jaundice neonatorum affects 39.7 babies per 1000 live births 2,3. This unconjugated
bilirubin is a product of heme-protein catabolism, and its raised levels are potentially neuro toxic.
Irrespective of the cause of jaundice, the aim of therapy is to prevent unconjugated bilirubin
related neurotoxicity4. Phototherapy is the main stay of treatment of neonatal jaundice 5. It acts by
converting unconjugated bilirubin to more polar stereoisomer, which are less neurotoxic (cannot
cross blood brain barrier) and can easily be excreted in bile and urine 6. The effectiveness of
phototherapy depends upon the light energy emitted in the effective range of wavelengths, the
distance between the light source and the skin, and the surface area of the baby exposed to the
light7. Photoisomerization is a rapid process, in a study it was found that significant amount of
4Z, 15E photo isomers were formed in 15 minutes. Phototherapy can be applied both in
continuous and intermittent fashion. In a study, comparing intermittent and continuous
phototherapy, it was found that there is no significant difference in the efficacy of continuous
and intermittent phototherapy7. The continuous phototherapy may suppress the circadian rhythm.
The circadian rhythmicity is affected by the sensory environment. In utero, the circadian rhythm
of the fetus is well-stabilized at the end of the second trimester. The neural mechanisms to
respond to a circadian light stimulus are developed early in the third trimester 8. After birth, the
diurnal rhythm of infants is not well established due to various reasons, especially in infants
admitted to the neonatal intensive care unit (NICU) with continuous lighting or in the ones under
phototherapy lamps9.

A randomized controlled trial was conducted by Khaliq et al on 258 patients (Abdul Khaliq,
2016)10. Mean age of the patients was 3.89±1.83(p=.91) days, the mean baseline bilirubin was
17.56mg/dl±1.42 (p=.36). For the group A babies, the mean difference between the baseline and
follow-up bilirubin was 4.78mg/dl±1.20(p=.32). For the group B babies, the mean difference
between the baseline and follow-up bilirubin was 4.63mg/dl±1.18(p=.32). The difference
between the mean age on admission, mean baseline bilirubin, mean follow-up bilirubin, and the
mean decrease in serum bilirubin for both the groups A and B was statistically not significant.

Zhou S et al conducted a retrospective analysis of 307 patients with neonatal hemolytic


jaundice(Zhou, Wu, Ma, Zhang, & Liu, 2019)11. A total of 165 children treated with continuous blue
light irradiation were the continuous phototherapy group, including 89 males, and 76 females,
average age 5.87±0.65 days, average weight 3.92±0.27 kg. A total of 142 children treated with
intermittent blue light irradiation were the intermittent phototherapy group, with 74 males, and
68 females, average age 5.79±0.84 days, average weight 3.88±0.38 kg. Before treatment, there
was no significant difference in serum bilirubin levels between the continuous and the
intermittent phototherapy groups (P>0.050). There was no significant difference in serum
bilirubin levels between the continuous and the intermittent phototherapy groups at 24, 48 and 72
h after treatment (P>0.050).

Few studies were conducted in our region on comparison of both techniques; This study is aimed
to determine the local results of both intermittent and continuous phototherapy techniques. It will
help in decrease adverse effects associated with phototherapy and will be more helpful in mother
and baby bond. It will also help in treating more children within limited resources.

Objective

To compare the fall in serum bilirubin after 36 hours of intermittent versus continuous
phototherapy in the treatment of jaundice neonatorum.

Operational definition:

Neonatal Jaundice: Yellow discoloration of eyes or body at 2nd day of life to 10th day of life

Serum Bilirubin: serum bilirubin level of more than 10mg/dl in term neonates measured in the
laboratory.

Intermittent phototherapy: means observing on-off schedule 24 hours on and 12 hours off.
One hour on and 30 minutes off for each session of phototherapy application.

Continuous phototherapy: means observing on-off schedule 30 hours on and 6 hours off. Two
hours on and 24 minutes off for each session of phototherapy application.

Outcome: will be measured by measuring mean difference in serum bilirubin in both groups
from baseline to after 36 hours phototherapy.

Hypothesis: Intermittent phototherapy is equally effective in terms of fall in bilirubin level for
treatment of neonatal jaundice as compared to continuous phototherapy.

Materials and Methods:

Study design:

Randomized controlled trial

Setting:

Department of Paediatric Medicine, Nishter Hospital, Multan.

Duration:
Six months after approval of synopsis.

Sample size12:

Sample size is estimated by using open Epi software using formula for mean difference. Where,
Fall in serum bilirubin after 36 hours in continuous phototherapy group = 4.78±1.2mg/dl.
Fall in serum bilirubin after 36 hours in intermittent phototherapy group = 4.6±1.2mg/dl.
Power of study = 80%
Confidence level = 95%
Sample Size = 1396 (698 in each group)
Inclusion Criteria:
 Full term neonates (≥37weeks) with age >24 hours and ≤10days
 Serum bilirubin level >10mg/dl
 APGAR at 5 minutes greater than 6
Exclusion Criteria:
 Patients on intensive care i.e. ventilator, endotracheal intubation, and peritoneal dialysis.
 Patients with major congenital malformation like cardiac, skeletal, renal, dysmorphism.
 Sepsis (positive blood culture), fits, reluctance to feed.
 Platelets <50000.
Data Collection Procedure
Study will be started after obtaining ethical approval from hospital ethical board. Informed
consents will be taken from the parents, (father/mother, which one available) of those babies
fulfilling the inclusion criterion, and which will be enrolled in the study from the Neonatal unit
of Children Ward. Baseline demographic data like age, gender will be recorded. All neonates
will be randomly allocated in two groups by lottery method. Group A patients will receive
continuous phototherapy for 30 hours and 6 hours off. This time is allocated for feeding and
diaper change. Group B patients will receive intermittent phototherapy (24 hours on and 12
hours off. The on off timing, of phototherapy will be observed by the researcher. Blood samples
will be taken and sent to hospital labs, (on arrival before starting phototherapy, every 12 hours
while on phototherapy, and at 36th hour), by the researcher himself for serum bilirubin levels.
The results will be collected from the lab by the researcher and the serum bilirubin levels will be
noted down in the Proforma. Both the groups will receive phototherapy from apparatus of same
manufacturer and same age. The height of phototherapy light (distance between the light source
and the infant) will be kept similar for both groups. The follow up bilirubin will be measured at
36 hours. Study data will be recorded on predesigned Performa.
Data Analysis:

Data will be analyzed by using SPSS version 23. Mean and SD will be calculated for age,
bilirubin at baseline and after 36 hours and difference in mean bilirubin after follow-up.
Frequency and percentages will be calculated for qualitative variables e,g gender, age and serum
bilirubin. Post stratification independent t test was applied. P value ≤0.05 will be taken as
significant.

References

1. Khaliq A. Comparison of continuous with intermittent phototherapy in the treatment of


neonatal jaundice. J Postgrad Med Inst 2016;30(2): 173-6.
2. lori kenari R, Aziznejadroshan P, Haghshenas Mojaveri M, Hajian Tilaki K. Comparing
the effect of kangaroo mother care and field massage on serum bilirubin level of term
neonates with hyperbilirubinemia under phototherapy in the neonatal ward. Caspian J
Intern Med. 2020;11(1):34-40.
3. Topal I, Mertoglu C, Surucu Kara I. Thiol-disulfide homeostasis, serum ferroxidase
activity, and serum ischemia modified albumin levels in neonatal jaundice. Fetal Pediatr
Pathol . 2019;38(2):138–45.
4. Jalalodini A, Nourian M, Goodarzvand L. The effect of tactile-kinesthetic massage on
transcutaneous bilirubin in term neonates with hyperbilirubinemia care with
phototherapy. Iranian J Nurs Res. 2016;11(5):13–9.
5. Tikmani SS, Warraich HJ, Abbasi F, Rizvi A, Darmstadt GL, Zaidi AK. Incidence of
neonatal hyperbilirubinemia: a population-based prospective study in Pakistan. Trop Med
Int Health 2010;15(5):502-7.
6. Mreihil K, McDonagh AF, Nakstad B, Hansen TW. Early isomerization of bilirubin in
phototherapy of neonatal jaundice. Pediatr Res 2010;67(6):656-9.
7. Boundy EO, Dastjerdi R, Spiegelman D. Kangaroo mother care and neonatal outcomes: a
meta-analysis. Pediatrics .  2016;137(1):e20152238.
8. Goudarzvand L, Dabirian A, Nourian M, Jafarimanesh H, Ranjbaran M. Comparison of
conventional phototherapy and phototherapy along with Kangaroo mother care on
cutaneous bilirubin of neonates with physiological jaundice. J Matern Fetal Neonatal
Med. 2019;32(8):1280–4.
9. Karbandi S, Boskabadi H, Esmaeily H, Kalateh M. Effects of massage on duration of
phototherapy in premature infants admitted to a neonatal intensive care unit. J Babol
Univ Med Sci. 2016;18(1):11–7.
10. Khaliq A. Comparison of continuous with intermittent phototherapy in the treatment of
neonatal jaundice. J Postgrad Med Inst 2016;30(2): 173-6.
11. Zhou S, Wu X, Ma A, Zhang M, Liu Y. Analysis of therapeutic effect of intermittent and
continuous phototherapy on neonatal hemolytic jaundice. Exp Ther Med. 2019
May;17(5):4007-4012. doi: 10.3892/etm.2019.7432. Epub 2019 Mar 22.
12. Khaliq A. Comparison of continuous with intermittent phototherapy in the treatment of
neonatal jaundice. J Postgrad Med Inst 2016;30(2): 173-6
Performa

Name: ______________________________ Date: _______________________


Hospital Reg #: __________________________ Contact:_____________________
Age: ___________________________________ Address:____________________
Gender: ______________________________________________________________

Groups: A/B
i. Bilirubin at Baseline: -----------------------mg/dl
ii. Bilirubin at 36 hours: -----------------------mg/dl
iii. Mean difference after follow up: _________mg/dl

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