Download RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARANATAKA.
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. NAME OF THE CANDITATE
AND ADDRESS
: MR BASKARAN.N,
First year M.Sc Nursing,
Mysore road kambipura,
Bangalore.
2. NAME OF THE INSTITUTION
: Rajarajeswari College of Nursing
3. COURSE OF STUDY & SUBJECT
: 1st year Ms.c Nursing
4. DATE OF ADMISSION
: 31-10-09
5. TITLE OF THE TOPIC
: A COMPARATIVE STUDY TO DETERMINE
THE EFFECTIVENESS OF CONTINUOUS
VERSUS INTERMITTENT
PHOTOTHERAPY IN REDUCTION OF
LEVEL OF BILURUBIN AMONG BABIES
WITH HYPERBILURUMINIEA IN
SELECTED HOSPITAL AT
BANGALORE.
6. BRIEF RESUME OF INTEND WORK
INTRODUCTION
Phototherapy is safe and effective in neonatal hyperbilirubinemia. Despite its worldwide
application, specific questions regarding methods of optimizing efficacy remain unanswered. Turning
the infant is believed to increase the efficacy of phototherapy and this practice was routinely used in
approximately half of neonatal departments in a recent survey. some degree of jaundice or
hyperbilirubinemia occurs in most newborns. Severe neonatal hyperbilirubinemia is associated with
kernicterus, a rare condition characterized by athetoid spasticity, gaze and visual abnormalities, and
sensory-neural hearing loss in survivors. It may also be associated with mental retardation1.
A 2003 review concluded that kernicterus has a mortality of at least 10% and a
morbidity of at least 70%.The true incidence of kernicterus is unknown because it is not a mandatory
reportable disease. However, a 2001 Joint Commission Sentinel Event Alert stated that cases of
kernicterus have continued to be reported in recent years. Efforts have been made by clinicians and
investigators to eliminate this rare disease by instituting system-level measures to screen for
hyperbilirubinemia and prevent the occurrence of kernicterus.3–5 Most notable among these is a set of
clinical practice guideline concerning the management of hyperbilirubinemia in infants of at least 35
weeks gestation published by the American Academy of Pediatrics2.
The 2004 guideline emphasizes the attention to risk factors associated with hyperbilirubinemia,
close follow-up of at-risk infants, and the use of phototherapy and exchange transfusion to decrease the
level of hyperbilirubinemia as appropriate. Bilirubin and its photo isomers in the biological fluids of a
hyperbilirubinaemic newborn infant before and during phototherapy were analyzed by a recently
improved HPLC method. In the serum, the percentages of and bilirubin in the total bilirubin
concentration before phototherapy were approximately 10% and on average increased over 1.5-fold at 2
hrs after initiation of phototherapy3.
The percentage of the (Ecyclobilirubin in the serum bilirubin was under 1 %. In the bile,
the mean concentration of bilirubin, derived mainly from bilirubin, nearly tripled during phototherapy.
The Ecyclobilirubin concentration in the bile was very low before phototherapy, increased nearly tenfold at 3 h after initiation of phototherapy, and was 5- to 6-fold as high as that of bilirubin. In the urine,
upon exposure to light, the urinary concentration of Ecyclobilirubin is apparently equivalent to half of
the biliary concentration of bilirubin and one-fifth of that of Ecyclobilirubin. It was concluded that
during phototherapy of neonatal hyperbilirubinaemia the structural photo isomer Ecyclobilirubin
predominates considerably over the geometric photo isomer Phototherapy has emerged as the most
widely form of therapy for the treatment and prophylaxis of neonatal unconjugated hyperbilirubinemia4.
Original article maturity, presence or absence of hemolysis, or degree of skin pigmentation
phototherapy appears to be safe given the decades of experience with its use in the United States and
Europe and the lack of reported serious long-term side effects of short term phototherapy thus far The
initial report from the Collaborative Study on the Effectiveness and Safety of Phototherapy, undertaken
under the auspices of the National Institute of Child Health and Human Development, demonstrated that
infants receiving phototherapy require significantly fewer exchange transfusions. Furthermore,
subsequent follow-up studies revealed no adverse outcome in the neonates who received phototherapy
in the neonatal period Phototherapy can be used either as therapy or as prophylaxis. Two different
mechanisms have been proposed to explain the action of phototherapy in reducing serum bilirubin
concentrations in newborn infants; photoisomerization and photo oxidation. Compared with the
photoisomerization pathway, the oxidation mechanism appears to play a very minor role in photo
catabolism of unconjugated bilirubin in vivo Clinical studies comparing intermittent to continuous
phototherapy have yielded conflicting results.5
6.1 NEED FOR STUDY:
Signs of Neonatal Jaundice are seen within the first three days of birth in 80% of preterm
babies and 60% of full-term infants. The Journal of pediatrics reports a retrospective study, which
observed that the incidence of Jaundice is higher in breast- fed babies than in the formula- fed ones.
Asian male babies and Native American ones are reported to be most affected by Neonatal Jaundice.
They are followed by Caucasian infants who in turn are followed by African Neonates.
Babies who are either small or large for gestational age are at an increased risk of developing Neonatal
Jaundice. Large for gestational age babies are seen in mothers with diabetes6
Physiological jaundice is the most common type and effects over 50% of babies. Due to an
immature liver, bilirubin is processed slower. This type of jaundice appears at 2 to 3 days of age and
commonly disappears by 1 to 2 weeks of age. Bilirubin levels are not harmful with this type of jaundice.
Jaundice becomes detectable to the naked eye when the total serum bilirubin level exceeds about 85μmo
(5 mg/100ml) and most babies become visibly jaundiced in the first week of life. Unfortunately the
terminology used in many texts Talks of jaundice being ‘moderate’ when it exceeds 200μmo and
‘severe’ when it exceeds 250μmo on any such definition ‘severe’ jaundice develops in a third of all
breast fed babies in the first week of life! Such lax use of language undoubtedly triggers a lot of
unnecessary investigation7.
Jaundice is only really ‘actionable’ in the otherwise healthy term baby when the level
exceeds 340μmo (20 mg/100ml) and potentially dangerous when it exceeds 43μmo (25 mg/100ml).
Phototherapy would not need to be given so often if it were administered more effectively when given.
The graph shown here documents how the bilirubin level varied over time in a large group of mature
exclusively breast fed babies – most other ‘normative’ charts document the levels seen in a population
where at least a third of the babies were bottle fed. the investigator investigate the prevalence the rate of
hyperbilirubinemia is high. The phototherapy play significant role in reduction of bilurubin in babies
with hyperbilirubinemia. So the researcher has the interest to determine the effectiveness between
continuous and intermittent phototherapy to find the rapid recovery from hyperbilirubinemia8.
6.2 REVIEW OF LITERATURE:
“A study was conducted on effectiveness of intermittent versus continuous
phototherapy in reduction of level of bilirubin among babies with hyperbilirubinemia” at Iran the
objective of this study was to assess effect of phototherapy with babies complication the study was
performed on 114 babies with hyperbilirubinemia. The result concluded that phototherapy cycle of one
hour on and one hour off is as effective as continuous phototherapy in treatment of hyperbilirubinemia9
The study was conducted on “Serum bilirubin kinetics in intermittent phototherapy of
physiological jaundice” at Japan with the objectives of to treat the babies in the easiest way to minimize
hospital duration Thirty four term babies with physiological jaundice were subjected to continuous
phototherapy and to two regimens of intermittent phototherapy. The difference in serum bilirubin
kinetics between the three groups of treated babies was insignificant; a schedule of one in four hours of
irradiation achieved the same treatment effect as continuous phototherapy10.
The study was conducted on Regardless of different protocols of phototherapy, the
Number-Needed-to-Treat (NNT) for prevention of serum bilirubin level exceeding 20 mg/dL ranged
from six to 10 in infants of at least 34 weeks gestation at America This implies that one needs to treat
six to 10 jaundiced neonates with TSB ≥ 15 mg/dL by phototherapy in order to prevent the TSB in one
infant from rising above 20 mg/dL. Phototherapy combined with cessation of breastfeeding and
substitution with formula was the most efficient treatment protocol for infants of at least 34 weeks
gestation with jaundice. Eight studies examined the effect of bilirubin reduction on brainstem auditory
evoked response (BAER). All consistently showed treatments for neonatal hyperbilirubinemia
significantly improved abnormal BAER’s in both healthy jaundiced infants and jaundiced infants with
hemolytic disease Three studies evaluated the effect of phototherapy on visual outcomes. All showed no
short- or long-term (up to 36 months) effect on vision as a result of phototherapy when infants’ eyes
were properly protected during treatment11.
A research was conducted on “bilurubin included cell death during continuous and
intermittent phototherapy and in the dark “at Norway the study objectives is to assess the duration of
intermittent vs. continuous phototherapy, and to assess the bilurubin level during the treatment I.e. cell
death the researchers compared continuous and intermittent light exposure in the presence of bilurubin
with respect the cellular damage. The result showed that continuous and intermittent light exposure
caused the same degree of apoptotic cell death while the cells underwent more necrotic death after
intermittent exposure12.
A research was conducted on “To look for the effect of position changing on bilurubin level
during the continuous and intermittent phototherapy” at Israel the study objective was to assess the
phototherapy with changing position and effect of continuous and intermittent phototherapy They
conducted the pilot study in term infants requiring phototherapy in order to determine the time required
to clear the skin of bilurubin. Balancing time was 150 minutes. They conducted a randomized study
complaining turning the baby in supine position only. They conducted that infants should be nursed
supine during phototherapy infants in the supine group showed a significally larger drop in serum total
bilurubin concentration and required shorter duration of phototherapy13
A study was conducted to determine the incidence of post-phototherapy neonatal plasma
total bilurubin rebound at England a prospective clinical survey was performed on 226 and neonates
treated with phototherapy, neonates were tested for PTB 24 hours after discontinuation of phototherapy
a total of 30 neonates developed significant rebound they conducted that post phototherapy neonates
bilurubin rebound to clinically significant levels may occur especially in cases of prematurity14.
“A study was conducted on effectiveness of phototherapy treatment” they describe in
a very simple way that staff can assess the effectiveness of the treatment they concluded that the
effectiveness is greatly influenced by how for they are position from the child and can be almost
doubled by the cot which could be easily accesse by the staffs15
STATEMENT OF THE PROBLEM
“A comparative study to determine the effectiveness of Continuous vs. Intermittent
Phototherapy in reduction of level of bilurubin among babies with hyperbiluruminiea selected
hospital at Bangalore”.
6.3 OBJECTIVES OF THE STUDY
1. To determine the effectiveness of continuous phototherapy of babies with hyperbilirubinemia in
group-I
2. To determine the effectiveness of intermittent phototherapy of babies with hyperbilirubinemia in
group-I
3. To compare the effectiveness of intermittent and continuous phototherapy in reduction of
Bilurubin level
4. To find association between effectiveness of continuous phototherapy and demographic
variables of babies
5. To find association between effectiveness of intermittent phototherapy and demographic
variables of babies
HYPOTHESES
H1-There is a significant difference between mean post assessment score of continuous
phototherapy and mean post assessment of intermittent phototherapy in reduction of level of Bilurubin.
H2- There is a significant association between the post test score of continuous vs.
intermittent phototherapy in reduction of Bilurubin level among babies with hyperbilirubinemia with
their selected demographic variables
6.3.1. ASSUMPTIONS
1. Intermittent phototherapy as effective as continuous phototherapy
2. Babies with hyperbilirubinemia may prone to develop complications
6.3.2 VARIABLES
(a)Dependent
Reduction in level of Bilurubin
(b)Independent
Continuous and intermittent phototherapy
6.3.3 OPERATIONAL DEFINITIONS
Comparative study
It refers to the basis of analytic epidemiology the statistical comparison between
groups.
Bilurubin
It refers to the orange pigmentation of bile formed primarily by the breakdown of
hemoglobin in red blood cells after termination of their lifespan
Hyperbilirubinemia
It refers to the increased Bilurubin level in the blood
Intermittent phototherapy
It refers to the phototherapy is given to babies with hyperbiluruminiea that as to be
given alternatively by each one hour on and 4hours off.
Continuous phototherapy
It refers to the phototherapy is given to babies with hyperbiluruminiea that as to be
given continuously by each 15minutes on and 30 minutes off.
7. MATERIALS AND METHODS
7.1 Source of data
New born babies who are admitted in NICU with phototherapy, who will meet the
inclusive criteria
7.2 Method of collection of data
7.2.1 Definition of the study subject
New born babies who are admitted in NICU with phototherapy who will meet the inclusive
criteria
7.2.2 Inclusion and Exclusion Criteria
a) Inclusion Criteria
1. Babies who have hyperbiluruminiea
2. Babies weight above 2000gm
3. Babies gestational age above 32 weeks
b) Exclusion criteria
1. Babies who are having congenital abnormalities
2. Mothers those who are not willing
7.2.3 Research Approach:
Quantitative approach
7.2.4 Research Design
True experimental study
7.2.5 Setting
The study will be conducted in selected hospital, Bangalore
7.2.6 Sampling technique
Random sampling technique
7.2.7 A) Sample size
30- New born babies who are admitted in NICU with phototherapy who will meet the
inclusive criteria
b) Duration of the study
4 weeks
7.2.8 Tools of Research
PART I: Socio demographic data
Part II
Bilurubin assessment scale
1. Normal level
- Below 5mg/dl
2. Mild jaundice
- 5 to 10 mg/dl
3. Moderate jaundice - 10 to 15 mg/dl
4. Severe jaundice
- Above 15mg/dl
CRAMER’S DERMAL ZONES INDEX OF NEONATAL JAUNDICE:
Zone I face
: 5mg/dl
Zone II chest and upper abdomen
: 10mg/dl
Zone III thighs and upper arms
: 12mg/dl
Zone IV legs and forearm
: 15mg/dl
Zone V palms and soles
: 15mg/dl
7.2.9 Collection of data
The investigator collects the data by using bilurubin assessment scale. The sample will
be collected by randomly, even no’s of the sample denotes the group-I and odd no’s of sample ,s
denotes the group-II Before placing the sample in to the phototherapy bilurubin level will be checked
and classified based on the bilurubin assessment scale .the researcher check the bilurubin level every 12
hours for 2 days during phototherapy. After 48 hours of phototherapy the bilurubin level will be
checked, classified and compare with each group to know the effectiveness based on bilurubin
assessment scale.
7.2.10 Method of Data Analysis
And presentation
1. The investigator will use descriptive statistics such as mean, median, and standard deviation and
inferential statistics like “t” test and chi-square test will be used.
2. The analyzed data will presented in the form of tables, diagram and graph
7.3 Does the study require any investigation to be conducted patients or other human or animals?
If so describe briefly?
Yes with prior consent from samples the study will be conducted on children
with hyperbiluruminiea regarding phototherapy to reduce the Bilurubin level in selected hospital at
Bangalore
7.4 Has ethical clearance has been obtained from your institution in case of?
Yes permission will be obtained from the concerned person and authority of
the institution before the study privacy, confidentiality and anonymity will be guarded scientific
objective of the study will be maintained with honesty and impartiality.
8. LIST OF REFERENCES
1) Maisels MJ. Jaundice Neonatology: Pathology and Management of the Newborn, 6th edition
JB Lippincott, 2008 Philadelphia.
2) Ronald RJ, De Sandre GH, Sibley Neonatal jaundice and liver disease Neonatal-Perinatal
Medicine Diseases of the fetus and infant 8th edition Philadelphia, Mosby.
3) Scheidt PC, Bryla DA, Phototherapy for neonatal hyperbilirubinemia six year follow-up of
NICHD clinical trial 2007.
4) S Chung M, Kulig J, An evidence based review of important issues concerning neonatal 2nd
edition 2004 hyperbilirubinemia.
5) Forfar & anneil’s text book of peadiatrics 6th edition Lippincott
6) Brown AK, Kim MH, Efficacy of phototherapy in prevention and management of neonatal
hyperbilirubinemia UK 2002.
7) Rubaltelli FF, Zanardo V, Granati B.Effect of various phototherapy regimens on bilirubin
decrement Pediatrics 1978
8) Maisels MJ. Phototherapy Maisels MJ, Watchko JF edition Neonatal Jaundice New York
Hardwar academic Publishers.
9) Shane Watchko JF Neonatal Jaundice Phototherapy New York. Hardwar Academic Publishers.
10) Pedram niknaf abdol Jaundice Neonatology: Pathology and Management of the Newborn. 6th
edition JB Lippincott. Philadelphia
11) Sp Lau KP fung Neonatal jaundice and liver disease. In Neonatal-Perinatal Medicine: Diseases
of the fetus and Infant.8th edition Philadelphia
12) American
Academy
of
Pediatrics
Clinical
Practice
Guideline.
Management
of
hyperbilirubinemia in the newborn Infant 35 or more weeks of gestation. Subcommittee on
Hyperbilirubinemia.
13) Ellen harmazol Phototherapy for neonatal hyperbilirubinemia: Six year follow-up of
clinical trial 2nd edition UK
14) E shine well M.D Phototherapy for neonatal jaundice.3rd edition England
15) Verman statement of phototherapy using in position 2nd edition 2008
Websites:
www.pubmed.com
www.childspo.com
www.baby.com
www.scird.com
www.medspace.com
NICHD
Signature of the candidate
NAME AND DESIGNATION OF
GUIDE
: Ms MAHALAKHSMI M.Sc (N),
HOD, PEADIATRIC NURSING,
RAJARAJESWARI COLLEGE OF NURSING,
BANGALORE.
SIGNATURE
:
(Remarks of the guide)
: The present study provide guidelines for nurses to
practice effective method of phototherapy
CO-GUIDE (IF ANY)
:
: Ms. PARVATHI M.Sc (N)
LECTURER RAJARAJESWARI COLLEGE
OF NURSING BANGALORE.
SIGNATURE
:
HEAD OF THE DEPARTMENT
: Ms MAHALAKHSMI M.Sc (N),
HOD, PEADIATRIC NURSING,
RAJARAJESWARI COLLEGE OF NURSING,
BANGALORE
Signature
:
Remarks of the principal
: The topic selected for study is relevant and forwarded
for needful action
Signature
:
ETHICAL COMMITTEE CLEARANCE
1. Title of the Dissertation
: A comparative study to determine the effectiveness of
continuous vs. intermittent Phototherapy in reduction
of level of Bilurubin among babies with
hyperbilirubinaemia in selected hospital at
Bangalore.
2. Name of the Candidate
: Mr.Baskaran.N
3. Subject
: M.Sc Nursing Child Health Nursing
4. Name of the Guide
5. Approved/Not Approved
: MIS. MAHALAKSHMI.MSC NURSING
:
(If not approved suggestions)
Head of the department of
Head of the department of
Pediatric Nursing
Medical Surgical Nursing
Rajarajeswari College of Nursing
Rajarajeswari College of Nursing
Bangalore.
Bangalore.
Head of the department of
Head of the department of
OBG Nursing
Psychiatric nursing
Rajarajeswari College of Nursing
Rajarajeswari College of Nursing
Bangalore.
Bangalore.
Head of the department of community
Rajarajeswari College of Nursing
Bangalore.
Principal
Rajarajeswari College of Nursing
Bangalore