From,Date: 05-10-2012
DR.VIBHAVARI.V.SHIRAHATTI, Bellary
Post Graduate Student in M.D. Paediatrics,
Department of Paediatrics,
VIMS, Bellary.
To,
The Principal,
Vijayanagara Institute of Medical Sciences,
Bellary.
THROUGH PROPER CHANNEL
Respected Sir,
Subject: Acceptance of registration and forwarding of synopsis.
In reference with the above cited subject, I the undersigned, studying Post Graduate course in M.D Paediatrics have been allotted the dissertation topic “EVALUATION OF LABORATORY PARAMETERS IN EARLY DIAGNOSIS OF NEONATAL SEPTICEMIA WITH SPECIAL REFERENCE TO C-REACTIVE PROTEIN.” under the guidance of Dr. L.N.REDDY ,Professor and Unit Chief(Unit B), Department of Paediatrics, VIMS, Bellary.
I request you to kindly forward the synopsis in the prescribed form to the University for approval.
Thanking you,
Yours faithfully,
(Dr .Vibhavari.V.Shirahatti)
Post Graduate Student in M.D,
Signature of the Guide Department of Paediatrics,
VIMS,Bellary.
Dr.L.N.REDDY,
Professor and Unit Chief(Unit B),
Department of Paediatrics,
VIMS, Bellary.
From, Date: 05-10-2012
The Professor and Head, Bellary.
Department of Paediatrics,
VIMS, Bellary.
To,
The Registrar,
RajivGandhiUniversity of Health Sciences,
Bangalore.
THROUGH PROPER CHANNEL
Respected Sir,
Sub: Submission of synopsis for registration and forwarding.
As per the regulations of the University for registration of dissertation topic, the following Post Graduate student in M.D. Paediatrics has been allotted the dissertation topic as follows by the official registration committee of all qualified and eligible guides of the department of Paediatrics.
NAME / TOPIC / GUIDEDR VIBHAVARI.V.SHIRAHATTI,
Post Graduate Student in M.D,
Dept. of Paediatrics,
VIMS, Bellary. / EVALUATION OF LABORATORY PARAMETERS IN EARLY DIAGNOSIS OF NEONATAL SEPTICEMIA WITH SPECIAL REFERENCE TO C-REACTIVE PROTEIN / Dr. L.N.REDDY,
Professor and Unit Chief
(Unit B),
Department of Paediatrics,
VIMS, Bellary.
Therefore, I kindly request you to communicate the acceptance of the dissertation topic allotted to the PG students at an early date.
Thanking you,
Yours faithfully
(Dr. Veera Shankar)
Professor and Head,
Signature of the Guide Department of Paediatrics ,
VIMS, Bellary.
Dr. L.N.Reddy,
Professor and Unit Chief(Unit B),
Department of Paediatrics,
VIMS, Bellary
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,
KARNATAKA
ANNEXURE- II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the Candidate and Address / DR VIBHAVARI .V. SHIRAHATTIPOST GRADUATE STUDENT IN M.D. PAEDIATRICS,
VIMS, BELLARY-583104
2. / Name of the Institution / VIJAYANAGARA INSTITUTE OF MEDICAL SCIENCES, BELLARY, KARNATAKA
3. / Course of study and subject / M.D.PAEDIATRICS
4. / Date of admission to course / 31-05-2012
5. / Title of the Topic / EVALUATION OF LABORATORY PARAMETERS IN EARLY DIAGNOSIS OF NEONATAL SEPTICEMIA WITH SPECIAL REFERENCE TO C-REACTIVE PROTEIN
6.
7. / Brief resume of the intended work:
6.1 Need for the study:
Almost 99% of the estimated 4 million annual neonatal deaths occur in developing countries. Although post-neonatal mortality rates have declined substantially, in large part due to successful child survival interventions, deaths in the neonatal period have been largely unaddressed as a global health concern and account for 40% of all deaths in children under 5. Despite the current increased efforts, much more needs to be accomplished to reduce neonatal mortality rates . Sepsis is the commonest cause of neonatal mortality; it is responsible for about 30-50% of the total neonatal deaths in developing countries. It is estimated that up to 20% of neonates develop sepsis and approximately 1% die of sepsis related causes. The gold standard for the diagnosis of neonatal septicemia is a positive Blood culture. Definitive culture results takes at least 48-72 hours resulting in treatment delays. Hence, certain rapid diagnostic tests such as C-reactive protein, Total WBC count, Absolute neutrophil count, Immature/Total Neutrophil count ratio and Platelet count; collectively termed as the 'Sepsis Screen’ is used to diagnose septicemia early and initiate a presumptive treatment while awaiting culture report.
Neonatal sepsis and neonatal septicaemia areterms that have been used to describe the systemic responseto infection and/or isolation of bacteria from theblood stream in the first 28 days of life . Globally, sepsisaccounts for 26% of all neonatal deaths with 98%of these deaths occurring in developing countries
Adequate and timely diagnosis of Neonatal septicemia remains an importantchallenge to the clinician. Blood culture remains thegold standard for definitive diagnosis but it takes at least48 hours by which time the infection may have progressedwith important consequences on the morbidityand mortality of the neonate , especially if antibiotictreatment is not initiated
immediately . Initiation ofantibiotic therapy before diagnostic results are availableis recommended for neonates with clinical signs or risk
factors of sepsis, but because the clinical signs ofNeonatal septicemia are often non-specific, empiric antibiotic therapymay result in the treatment of as many as 30 uninfectedneonates for every one who is eventually diagnosed tobe infected . Hence there is need for rapid screeningtest that can identify infected neonates at the time ofinitial assessment thus sparing the uninfected ones fromunnecessary antibiotic therapy.
C-reactive protein is an acute phase protein which maybe useful in the early diagnosis of Neonatal septicemia as it rises asmuch as a thousand fold within 4 to 6 hours of an inflammatoryprocess . As infection is the mostlikely cause of inflammation in the neonate, CRP hasbeen shown to be useful in the diagnosis of neonatal sepsis.
Unlike bloodculture, CRP level is not affected by prior antibiotic therapy.
The present study is aimed to evaluate the laboratory parameters in early diagnosis of neonatal septicemia with special emphasis on C-Reactive Protein.
6.2 Review of literature:
A prospective study was conducted on neonates admitted to neonatal intensive care unit (NICU) at Tirunelveli Medical College Hospital, Tirunelveli, Tamil Nadu, India from July’ 2010 and August’ 2010.50 babies were studied and CRP levels were obtained. CRP levels were elevated in culture positive babies with a positive predictive value of 38.8 % and negative predictive value of 78.1 %.
Another study involving four hundred and twenty neonates with clinical suspicion of sepsis were prospectively studied over a 6 month period. Blood
was obtained from each subject recruited for the qualitative estimation of CRP. Blood culturewas used as gold standard for diagnosis of Neonatal septicemia.
Of 420 neonates studied, 196 (46.7%) had positive CRP while 181 (43.1%) had positive blood culture. The sensitivity, specificity, positive and negative predictive values of CRP were 74.0%, 74.1%, 68.4% and 79.0%respectively.
A similar study was conducted at AcharyaVinobaBhaveRuralHospital, Sawangi (M) for a period of two years from 1st July 2008 to 30th June 2010. Neonates who were clinically suspected to have bacterial infections within the first 48 hours of life, based on the risk factors and/or clinical features, were subjected to various haematological screening parameters and blood cultures. Among the 3574 live births during the study period , 189 episodes of sepsis occurred, the incidence being 52.88/1000 livebirth. Culture proven sepsis occurred in 37 cases. Among culture positive cases, septicemia was more common among male neonates.
6.3 Objectives of the study :
- To evaluate the laboratory parameters in early diagnosis of neonatal septicemia with special reference to C-Reactive protein.
- To study the accuracy of CRP values in babies to predict neonatal septicemia.
7.1 Source of data: Data will be collected from neonates admitted in NICU, VIMS, Bellary with history/ clinical findings suggestive of septicemia.
7.2 Method of collection of data:( including sampling procedure if any)
The present study will include blood picture examination of venepuncture-collected blood from infants getting admitted in NICU, Vijayanagara Institute Of Medical Sciences, Bellary.
Relevant clinical details will be taken & the collected blood will be processed for the study of parameters viz C-reactive protein, Total WBC count, Absolute neutrophil count, Immature/Total Neutrophil count ratio and Platelet count.
Study Design : Cross Sectional Study
Study Area : Neonatal Intensive Care Unit , Vijayanagara Institute Of Medical Sciences , Bellary
Study Period : 01-10-2012 TO 31-08-2013
Study Subjects: Neonates admitted in NICU, VIMS, Bellary fulfilling the inclusion criteria.
Sample size: This study aims to have a sample size not less than 50
Inclusion criteria:
- Age less than 28 days old
2. Neonates < 28 days clinically suspected as a case of neonatal
septicemia will be included.
Exclusion criteria :
- Babies >/= 29 days old
- Babies admitted in NICU for other morbidities like perinatal asphyxia, hyperbilirubinemia etc.
The study requires investigations (Blood test) to be conducted on patients by the investigator.
7.4 Has ethical clearance been obtained from your institution?
Yes
8.
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Why? Lancet 2005, 365:891–900.
3. Omene JA: Neonatal Septicaemia in Benin city, Nigeria: A Review of
74 cases. Trop Geogr Med 1979, 31:35–39.
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and Tumor Necrosis Factor Alpha for Diagnosing Late Neonatal Sepsis.
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doi:10.1186/2047-2994-1-22
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9 / Signature of the Candidate:
10 / Remarks of Guide
11 / Name & Designation / DR.L.N.REDDY,
PROFESSOR AND UNIT
CHIEF(UNIT B), DEPARTMENT OF PAEDIATRICS,
VIJAYANAGARA INSTITUTE OF MEDICAL SCIENCES,
BELLARY-583104
11.1 / Guide: / DR. L.N.REDDY
11.2 / Signature
11.3 / Co-guide(If any)
11.4 / Head of Department / DR.VEERASHANKAR.M. PROFESSOR AND HEAD OF DEPARTMENT, DEPARTMENT OF PAEDIATRICS, VIJAYANAGARA INSTITUTE OF MEDICAL SCIENCES,
BELLARY-583104
11.5 / Signature
12. / 12.1
12.2 / Remarks of Chairman and Principal
Signature /
.