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1. “A Study On The Effect Of Phototherapy On Various Hematological
And Biochemical Parameters In Neonatal Hyperbilirubinemia In A
Tertiary Care Centre”
DEPARTMENT OF PAEDIATRICS
CHIRAYU MEDICAL COLLEGE AND HOSPITAL,BHOPAL (MP)
Principal Investigator: Guide:
Dr. PRIYANSHI SHRIVASTAVA, Dr. Jaishree Ambhore ,
P.G Resident 1st Year, Professor & HOD,
Department of Paediatrics, Department of Paediatrics,
Chirayu Medical College and Hospital,Bhopal Chirayu Medical College and Hospital,
Bhopal Bhopal

2. INTRODUCTION
 Neonatal Hyperbilirubinemia is a common clinical problem encountered during
the neonatal period.
 It occurs due to excessive formation of unconjugated (indirect bilirubin) and
inability of neonatal liver to rapidly clear it from blood.

3.  High serum bilirubin levels can be toxic for central nervous system
development and may cause behavioral and neurological impairment
(Kernicterus) even in term newborns. Pathological jaundice may also lead to
deafness, cerebral palsy and/or mental retardation. [1]
 The treatment options for jaundice includes phototherapy , exchange
transfusion, and pharmacological treatment like phenobarbitone, intravenous
immunoglobulins (IVIG), metallo-porphyrins etc.[2]

4.  Phototherapy is one of the most effective way available in preventing the
neurotoxic complications of indirect hyperbilirubinemia .It causes change in
the structure of bilirubin and resulting isomers like lumirubin which is the
water soluble form & it radially excreted in bile and urine .Phototherapy is
safe, but is only used when needed (usually for two to three days after which
the baby’s liver takes over).[3]

5.  The side effects of phototherapy are loose stools, hyperthermia,
dehydration, fluid loss, skin rash ,photo retinitis, low platelet count,
increased red cell osmotic fragility, bronze baby syndrome, riboflavin
deficiency and DNA damage.[4,5]

6.  A lesser known side effect, but potential complication of phototherapy is
electrolyte imbalance like hyponatremia, hypocalcemia, hypokalemia.
Early screening, quality of Neonatal care and timely intervention can improve
outcome of neonatal hyperbilirubinemia in neonates. So the purpose of this
study is to access effect of Phototherapy on various hematological and
biochemical parameters in Neonatal Hyperbilirubinemia[6,7,8,9].

7. RESEARCH QUESTION
 Does phototherapy affect biochemical and
hematological parameters of neonates suffering from
hyperbilirubinemia?

8. AIM:
• To Asses the effect of Phototherapy on various
Hematological and biochemical parameters in
Neonatal Hyperbillirubinemia.

9. OBJECTIVE
1.To asses the effect of Phototherapy on various Hematological and Biochemical
parameters in Neonatal Hyperbilirubinemia.
2. To compare the changes in various hematological and biochemical parameters
including complete blood count, total bilirubin, direct bilirubin, indirect
bilirubin, serum electrolyte(sodium, potassium, calcium), urea and creatinine
levels in plasma/serum of pre and post Phototherapy.

10. METHOD/PROCEDURE
1. STUDY DESIGN: Comparitive,Cross Sectional, Descriptive Study.
2. STUDY SETTING: The study will be conducted in Neonatal Intensive Care Unit in the
Department of Paediatrics , Chirayu Medical College and Hospital, Bhopal, Madhya
Pradesh, India, after approval by ethics committee over a period of 18 months.
3. STUDY SIZE: The sample required for the study is 50 neonates admitted in NICU
requiring Phototherapy during a designated study period i.e, March 2023 to August 2024.
The sample size is calculated to be 50 with an estimation at 95% confidence interval &
10% margin of error and taking prevelance 11% from previous study[10].
4. DURATION OF STUDY: 18 months after approval from Institutional Ethics Committee.

11. ❖INCLUSION CRITERIA
1.The study will include all those inborn and outborn neonates who will be
admitted to receive Phototherapy for 24-48 hours duration during study
period paediatric department at Chirayu Medical College and Hospital,
Bhopal, (M.P).
❖EXCLUSION CRITERIA
1. Birth Asphyxia
2. Neonatal Septicemia
3. Respiratory Distress Syndrome
4. Major or Life threatening Congenital Malformation
5. Icterus in the range requiring Exchange Transfusion
6. Conjugated Hyperbilirubinemia

12. METHOD/PROCEDURE:
1.Written Informed consent will be taken from all the parents/guardians of the
neonates delivered in the Institution and out born neonates requiring
Phototherapy for 24 hours duration.
2.The neonates meeting the inclusion criteria will be chosen.
3.The venous sample will be collected aseptically during the course of
phototherapy in Plain and EDTA vial in Neonatal intensive care unit at the
Department of Paediatrics.

13. 5. The sample will be sent for analyses by the department of biochemistry and
pathology respectively.
6. The hematological and biochemical parameters will checked (first sample)
at the start of phototherapy and after discontinuation of phototherapy(second
sample).

14. METHODS:
1. Serum Bilirubin
• Total Bilirubin – Azobilirubin/ Dyphylline method in vitros 250 dry chemistry
analyze.
• Indirect Bilirubin – Dual wavelength spectrophotometric analysis in Vitros 250
• Direct Bilirubin- Direct bilirubin is calculated from total and Indirect Bilirubin in
Vitros 250.
2. Creatinine – Enzymatic method (Creatinine Amidohydrolase) in Vitros 250

15. 3. Sodium /Potassium – I selective electrode direct in electrolyte analyzer.
4. Urea – Calculated from blood urea Nitrogen ( BUN) Urea with Indicator is
method and is estimated in vitros 250
5.CBC- Automated CBC analyzer BC 6000 cell counter
6. Serum calcium-5-Nitro-5;methyl NM BAPTA on COBAS Integra 400 plus
chemistry analyzer.
7. Blood Group- Anti Sera method

16. ❖ANALYSIS AND STATISTICAL ASPECT
• Data will be analyzed using appropriate statistical test of significance
and appropriate statistical software like SPSS software as per
requirement.
• p-value < 0.05 will be taken as statistically significant.
 ETHICAL CONSIDERATION
• Study will be started after clearance from the Institutional Ethical
Committee.
• Informed written consent of the patient will be taken.
• Confidentiality of the patients data will be maintained.

17. ❖FINANCIAL IMPLICATION
• There are no financial implications
❖CONFLICT OF INTEREST
• There is no conflict of interest

18. REFRENCES
1.Kemper AR, Newman TB, Slaughter JL, et al. Clinical practice
guideline revision: Management of hyperbilirubinemia in the
newborn infant 35 or more week Gestation. SO Pediatrics.
2022;150(3)
2. Suneja S, Kumawat R, Saxena R. Effect of phototherapy on
various biochemical parameters in neonatal hyperbilirubinaemia: a
clinical insight. Indian J Neonat Med Res. 2018;6(2):PO13-PO18.

19. 3.Ullah S, Rahman K, Hedayati M. Hyperbilirubinemia in neonates: Types,
causes, clinical examinations, preventive measures and treatments: a
narrative review article. Iran J Public Health. 2016;45(5):558-68.
4. Rozario CI, Pillai PS, Ranamol T. Effect of
phototherapy on serum calcium level in term
newborns. Int J Contemp Pediatr. 2017;4:1975-9.
5. Taheri PA, Sajjadian N,Eivazzadeh B. Prevalence of phototherapy induced
hypocalcemia in term neonate. Iran J Pediatr. 2013;23(6):710-1

20. 6. Reddy AT, Bai KV, Shankar SU. Electrolyte changes following
phototherapy in neonatal hyperbilirubinemia. Inter J Sci Res.
2013;6(14):2319-7064.
7. Bezboruah G, Majumder AK. Electrolyte imbalances resulting
from phototherapy in neonatal hyperbilirubinemia. J Dent Med
Sci. 2019;18(8):51-8.

21. 8. Rangaswamy KB, Yeturi D, Gowda ANBL, Krishna C,
Samyuktha. Study of sodium and potassium changes in term
neonates receiving phototherapy. Int J Contemp Pediatr.
2019;6:1076-9.
9.Yadav RK, Sethi RS, Sethi AS, Kumar L, Chaurasia OS. The
evaluation of effect of phototherapy on serum calcium level.
People’s J Sci Res. 2012;5(2):1-4.

22. 10. Bhutani VK, Zipursky A, Blencowe H, Khanna R, Sgro M,
Ebbesen FNeonatal hyperbilirubinemia and Rhesus disease of
the newborn: incidence and impairment estimates for 2010 at
regional and global levels. Pediatr Res, 2013;1: 86–100

23. GANTT CHART
GANTT CHART
TOPIC OF THESIS:" A Study on the Effect of Phototherapy on various Hematological and Biochemical Parameters in Neonatal Hyperbilirubinemia in a Tertiary Care
Centre"
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& IEC Approval
Review of
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Pilot Study
Data Collection
Data Analysis
Write up for
First Draft
Write up for
Second Draft
Submission of
Dissertation

24. • PARTICIPANT INFORMATION SHEET
• TITLE OF THE STUDY :A Study on the Effect of Phototherapy on various Hematological and
Biochemical Parameters in Neonatal Hyperbilirubinemia in a Tertiary Care Centre : A Descriptive Study.
• PATIENT’s NAME-
• INTRODUCTION TO RESEARCH STUDY: We are inviting participants as we are conducting a study on
effect of phototherapy on various hematological and biochemical parameters in neonatal hyperbilirubinemia in
Neonatal Intensive Care Unit.
• PURPOSE OF THE STUDY: The purpose of the study is to assess effect of phototherapy on various
hematological and biochemical parameters in neonatal hyperbilirubinemia.
• WHO CAN TAKE PART: Any patient fulfilling the inclusion criteria
• WHO WILL BE CONDUCTING THE STUDY: Dr. Priyanshi Shrivastava, PG Resident (1st Year).
• MY ROLE/RESPONSIBILITY IN THE STUDY: If you decide to participate as a participant for this
study, you will be apprised and requested to answer all relevant question listed in the questionnaire.
• PARTICIPATION IS VOLUNTARY: Your participation in the study is entirely voluntary and of your own
volition. You are free to join the study. You will have the freedom to withdraw your participation at any point of
time during study. If you withdraw your participation from the study this decision of yours will not affect your
healthcare benefits from institute

25. • TOTAL STUDY DURATION: The entire duration of study is a period of 18 months i.e.
one year and six months.
• RISKS AND DISCOMFORTS OF THE STUDY: During interview, you have to
disclose only the facts which are related to study and there is no risk to you or your family,
involved in any way.
• BENEFITS OF THE STUDY: The above mentioned study shall benefit in research and
development of medical field by expanding the probability of identifying effect on various
Hematological and Biochemical parameters related to Phototherapy and early intervention.
• PARTICIPATION OF THE STUDY KEPT CONFIDENTIAL : All the information
disclosed during the study will be kept confidential. Your medical records will be only
reviewed by the medical team.
Name of the Principal investigator & Sign- Dr. Priyanshi Shrivastava Date –
PG Resident 1st Year
Department of Paediatrics
Chirayu Medical College and Hospital,Bhopal, M.P.

26. PATIENT CONSENT FORM
I _______________________, am assuring you that I have
all
the knowledge of this medical research and all the doubts
about the research have been resolved to me.
I accept that I have taken part in this research willingly
and I know that if I have any reason I can withdraw from
the research without any lawful liability.
I am aware that they can use my medical history for
another research. I am sure that my identity would be
kept confdential during any research.
I accept that as long as all the information that I have
provided for this research project is used for research
programme, without my objection.
1. Patient’s signature
Date:
Name

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28. PROFORMA
S.No. IPD No.
NAME: AGE/SEX
FATHER/MOTHER NAME: ADDRESS:
BIRTH ORDER: CONTACT NUMBER:
DATE AND TIME OF BIRTH: MODE OF DELIVERY:
BIRTH WEIGHT: DATE AND TIME OF EXAMINATION:
GESTATIONAL AGE:
 BALLARD:
 USG:
APGAR SCORE:
 1 MIN:
 5 MIN:
 10 MIN:
ANTENATAL HISTORY: O/E:
HR:
MOTHER’S AGE RR:
HYPERTENTION[Y/N]: SPO2:
INFANT OF DIABETIC MOTHER[Y/N]: CRT:
H/O DRUG SYSTEMIC EXAMINATION:
H/O TWINS[Y/N]: CVS:
IMMUNISATION STATUS OF MOTHER CNS:
BREASTFEEDING R/S:
NEONATAL HYPERBILIRUBINEMIA P/A:
OTHERS:
INVESTIGATIONS: PRE PHOTOTHERAPY POST PHOTOTHERAPY
HOURS OF LIFE:
SERUM BILIRUBIN
COMPLETE BLOOD COUNT
SERUM CALCIUM
SERUM MAGNESIUM
SERUM POTASSIUM
UREA
CREATININE
BLOOD GROUP

29. DECLARATION AND CHECKLIST
DECLARATION (Please tick as applicable)
I/We certify that the information provided in this application is complete and correct.
I/We confirm that all investigators have approved the submitted version of proposal/related documents.
I/We confirm that this study will be conducted in accordance with the latest ICMR National Ethical Guidelines for Biomedical and
Health Research involving Human Participants and other applicable regulations and guidelines including responsible.
I/We confirm that this study will be conducted in accordance with the Drugs and Cosmetics Act 1940 and its Rules 1945 as amended
from time to time, GCP guidelines and other applicable regulations and guidelines.
I/We will comply with all policies and guidelines of the institute and affiliated/collaborating institutions where this study will be
conducted.
I/We will ensure that personnel performing this study are qualified, appropriately trained and will adhere to the provisions of the EC
approved protocol.
I/We declare that the expenditure in case of injury related to the study will be taken care of.
If applicable,I/We confirm that an undertaking of what will be done with the leftover samples is provided, if applicable.
I/We confirm that we shall submit any protocol amendments, adverse events report, significant deviations from protocols, progress
reports (if required) and a final report and also participate in any audit of the study if needed.
I/We confirm that we will maintain accurate and complete records of all aspects of the study.
I/We will protect the privacy of participants and assure safety and confidentiality of study data and biological samples.
I/We hereby declare that I/any of the investigators, researchers and/or close relative(s), have no conflict of interest (Financial/Non-
Financial) with the sponsor(s) and outcome of study.
I/We have the following conflict of interest (PI/Co-PI):
1.
I/We declare/confirm that all necessary government approvals will be obtained as per requirements wherever applicable.
Name of PI: Dr. Priyanshi Shrivastava Signature; Date- ----------------
Name of Guide: Dr Jaishree Ambhore Signature: Date------------------
Name of HOD: Dr. Jaishree Ambhore Signature: Date-----------------

30. THANK YOU