RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BENGALURU

ANNEXURE-2

PROFORMA FOR REGISTRATION OF TOPIC FOR DISSERTATION

1. / Name of the candidate and address / DR RAMYA
MD IN PEDIATRICS, BMCRI, BENGALURU
2. / Name of the institution / BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BENGALURU
3. / Course of study and subject / M.D PEDIATRICS
4. / Date of admission to the course / 24.06.2013
5. / Title of the topic / COMPARATIVE STUDY OF SERUM PROCALCITONIN AND C-REACTIVE PROTEIN LEVELS IN NEONATAL SEPSIS
6 / Brief resume of the work intended:
6.1 Need for study:
Neonatal sepsis is a clinical syndrome characterized by systemic signs of infection and accompanied by bacteremia in the first month of life. Neonatal sepsis including pneumonia, meningitis and diarrhea is the most common cause (52%) of neonatal mortality in our country, which could be reduced, in large proportions by a high index of suspicion, prompt diagnosis and aggressive management of this condition 1.
PCT is an acute phase reactant, which may help in the diagnosis of sepsis. This is produced by monocytes in response to inflammation and infection. Latent period is short and about 4hrs & peaks by 6-8 hrs. An elevated level of procalcitonin has been shown to have a sensitivity and specificity in the range of (87-100%). Comparative studies have shown that procalcitonin is a more reliable marker of sepsis compared to CRP. The mean normal serum procalcitonin is around 2ng/ml.2
Procalcitonin (PCT), a protein of 116 amino acids with molecular weight of 13 kDa, was discovered in 1975 as a prohormone of calcitonin produced by C-cells of the thyroid gland and intracellular cleaved by proteolytic enzymes into the active hormone.The production of PCT during inflammation is linked with a bacterial endo-toxin and with inflammatory cytokines (TNF, IL-6). The probable sites of PCT production during inflammation are the neuroendocrine cells in the lungs & intestine3
CRP is produced by the liver and elevated in inflammations and it is not a specific test. Hence procalcitonin is superior to CRP in detection of neonatal infections.
Elevated Serum concentrations of procalcitonin distinguishes between Infection and inflammation (which CRP does not) and differentiates between bacterial and viral infection with high specificity.4
6.2 Review of Literature
C.Chelsia et-al in their study showed PCT concentration appear to be a highly specific and sensitive marker for early onset neonatal sepsis. PCT values .when compared with the initial 24 hours where sensitivity and specificity were 85.7% and 46.4% , rose to 100% and 89.2% respectively, within the subsequent 24 hrs. All patients with late onset infection had PCT concentrations > 2ng/ml (100% sensitivity and specificity) 1
JanneBlommendahl et al analyzed PCT test appeared to be useful for the diagnosis of neonatal sepsis .2 With cut off value of PCT 2ng/ml the sensitivity of PCT was 83% and specificity was 61%. With respect to CRP of 2.5 mg /L, the sensitivity was 69% and specificity was 96%.3
Dominique gendrel et alcompared the PCT and CRP concentrations and proved PCT is superior to CRP for diagnosis of neonatal sepsis.4
Enguix Studied showed aPCT sensitivity of 99 % and specificity of 89% with cut off value of 6.1ng/ml being taken,where as CRP showed a sensitivity of 96% and specificity of 84%, cut off value being 23mg /L. 5
Monneret et-alin their study showedProcalcitonin increased (up to 400 micrograms l-1 and returned to the normal range (< 0.1 microgram l-1) more quickly than C-reactive protein, suggesting that procalcitonin may be an early marker of favorable outcome.6
6.3Objectives of Study
  1. To assess the pro-calcitonin levels in neo-natal sepsis.
  2. 2. To compare pro-calictonin with CRP in neo-natal sepsis.

7 / Materials And Methods
7.1 Source of data: Neonates with clinical features of neo-natal sepsis at Vani Vilas, Bowring and Lady Curzon hospitals during the study period.
7.2 Method of collection of data
  1. Study Design: Prospective and Comparative study design
  2. Study Period: October 2013 to May 2015
  3. Place of study: Vanivillas Hospital & Bowring & Lady Curzon Hospital attached to BMCRI
  4. Sample size: 100 patients
  5. Inclusion Criteria: Term neonates with
  1. Clinical features of sepsis like feeding intolerance, lethargy, temperature instability, apnea, respiratory distress, poor perfusion, seizures, bradycardia, tachypnea, abdominal distention and vomiting.
  2. Maternal risk factors such as fever, prolonged rupture of amniotic membranes > 24hours. atvanivilas Bowring and Lady Curzon hospital in the study period.
  1. Exclusion Criteria:
  1. Pre-term babies.
  2. Babies those who have received antibiotics
  3. Babies with diabetic mothers.
  4. Babies with hyaline membrane disease.
  5. Babies with history of birth asphyxia.
  1. Methodology:
Informed consent will be taken from patients parents/guardians. Detailed history will be recorded. Patient fulfilling the exclusion and inclusion criteria will undergo the tests.
100 Term neonatal sepsis cases will be screened for blood culture , CRP and Procalcitonin levels.
Comparision is done between culture positive and culture negative with respect to the CRP and Procalcitonin levels.
  1. Statistical Analysis:
Prospective Studies will be Presented in terms of mean and standard deviations and median. Categorical variables between groups were analysed using chi-square test. Other substratified analysis will be carried out appropriately.
7.3 Does the study require any investigation or intervention to be conducted on other human?
•Yes
Blood Sampling for CBC, Blood Culture, CRP, Procalcitonin levels, chest X-ray, lumbar puncture & urine culture sensitivity if needed (Clinical diagnosis of sepsis at VVH, B&LCH).
7.4 Has The Ethical Clearence Been Obtained From Your Institution In Case Of 7.3?
Yes
8. List of references
  1. C.Cheisa , Panero A, RassiN,Stegagnom, De Glustim, Osborn JF et al . Reliability of procalcitonin concentration for the diagnosis of sepsis in neonates. Clinical Infectious Disease.1998 March;26(3):664-72
  1. Janneblommendahl et al, MarttiJanas, SeppoLaine, Ari Miettinen, Per Ashorn.Comparison of Procalcitonin with CRP and differential WBC count for diagnosis of culture proven neonatal sepsis. Scandinnavian journal of infectious diseases; vol 34, issue 8, Aug 2002 : 620 –622.
  1. AMC Van Rossum, RW Wulkan, Dr Oudesluys-murphy. Procalcitonin as an early marker of infectious in neonates. The lancet Infectious diseases ; Vol4 October 2004: 620 –630.
  1. Dominique gendrel, Marcel Assicot , Joseete Raymond, Florence Moulin, Christine Francousal, Jean Badoual. Procalcitonin as a marker for early diagnosis of neonatal sepsis. The journal of pediatrics ;April 1996 vol 128 : 570 to 573 .
  1. Enguix 2001 .Critically ill ,term neonates and control group –comparison of PCT and CRP for sensitivity and specificity .The lancet Infectious diseases ; Vol4 October 2004: 620 –630.
  1. Boo NY et al, JM Laboune, C Isaac, F Bienvience, G Putet, J Bienvence, Jan 2008.PCT & CRP levels in neonatal infections. actapediatrics; 1997 Feb 86(2) : 209-212. Usefulness of a semiquantitativeprocalcitonin test for early diagnosis of neonatal sepsis .
  1. Neonatal sepsis. Iap-nnfguidelines 2006 on level 2 neonantal care; iap, nnf, unicef: 157-183
  1. Janet M Rennie :Robertons text book of neonatology -4th Edition; 1026.
  1. Neonatal sepsis. Meherbanssinghs book of pediatric emergency -4th Edition; Buttery J.P. Sagar publications. :160.

9. / Signature of the Candidate
10. / Remarks of the guide / Neonatal sepsis is very important cause of neonatal mortality in our country. Hence, early diagnosis is essential
11. / Name & Designation of
(in block letters)
11.1. Guide / DR. SARALA SABAPATHY
PROFESSOR,
DEPARTMENT OF PEDIATRICS
B&LCH, BMCRI, BENGALURU.
11.2. Signature
11.3. Co- Guide / DR T NAGARATHNAMMA
PROFESSOR AND HEAD,
DEPT OF MICROBIOLOGY
BMCRI, BANGALORE.
11.4. Signature
11.5 HEAD of the Department / DR. GANGADHAR BELAVADI
PROFESSOR AND HOD,
DEPARTMENT OF PEDIATRICS,
BMCRI, BENGALURU.
11.6. Signature
12. / 12.1. Remarks of the Chairman &
Principal
12.2. Signature

.