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CTRI Number  CTRI/2021/01/030457 [Registered on: 14/01/2021] Trial Registered Prospectively
Last Modified On: 08/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Is procalcitonin useful in an newborn 
Scientific Title of Study   A retrospective observational study of cord blood procalcitonin as a routine screening tool for the diagnosis of early onset neonatal sepsis in neonates born to mothers after assisted fertility 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjunath V 
Designation  Pediatrician 
Affiliation  Gunasheela Surgical and Maternity Hospital 
Address  No. 1 Dewan N. Madhava Rao Road, Basavanagudi

Bangalore
KARNATAKA
560004
India 
Phone  080-46462600  
Fax    
Email  drmanjusharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjunath V 
Designation  Pediatrician 
Affiliation  Gunasheela Surgical and Maternity Hospital 
Address  No. 1 Dewan N. Madhava Rao Road, Basavanagudi

Bangalore
KARNATAKA
560004
India 
Phone  080-46462600  
Fax    
Email  drmanjusharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manjunath V 
Designation  Pediatrician 
Affiliation  Gunasheela Surgical and Maternity Hospital 
Address  No. 1 Dewan N. Madhava Rao Road, Basavanagudi

Bangalore
KARNATAKA
560004
India 
Phone  080-46462600  
Fax    
Email  drmanjusharma@gmail.com  
 
Source of Monetary or Material Support  
Gunasheela Surgical and Maternity Hospital, No. 1 Dewan N. Madhava Rao Road, Basavanagudi, Bangalore - 560 004 
 
Primary Sponsor  
Name  Gunasheela Surgical and Maternity Hospital 
Address  No. 1 Dewan N. Madhava Rao Road, Basavanagudi, Bangalore - 560 004 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjunath V  Gunasheela Surgical and Maternity Hospital  No. 1 Dewan N. Madhava Rao Road, Basavanagudi, Bangalore - 560 004
Bangalore
KARNATAKA 
080-46462600

drmanjusharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Gunasheela Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  All babies born to mothers who had assisted reproduction in Gunasheela surgical and maternity hospital, and all babies born to mothers who conceived spontaneously and delivered in Gunasheela surgical and maternity hospital. 
 
ExclusionCriteria 
Details  Major congenital anomalies, Patient transfer to another hospital 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Usefulness of procalcitonin in Assisted Reproductive Treatment in babies  December 2019 to April 2020 
 
Secondary Outcome  
Outcome  TimePoints 
Usefulness of procalcitonin in spontaneous pregnancies  December 2019 to April 2020 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Will be published in suitable journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Early onset neonatal sepsis (EONS) has been a major cause of morbidity and mortality in neonates , the clinical signs of early-onset neonatal sepsis (EONS) are nonspecific, sometimes late to develop, and indistinguishable from those of noninfectious disorders. The early diagnosis of EONS is difficult but is essential to improve outcomes. Early onset neonatal sepsis must be diagnosed while the patient is still asymptomatic. Such a diagnosis would rest on the identification of NBs at risk of early-onset sepsis.

Neonates born to mothers who are treated for infertility have an increased risk of preterm delivery, multiple pregnancies, and premature rupture of membranes (PROM). Each one of them individually is a risk factor for neonatal sepsis

In our assisted fertility center, we have observed a similar pattern, and few cases resulted in EONS without risk factors.  Blood culture is the gold standard for the diagnosis of neonatal sepsis but takes a long time. Clinical diagnosis is difficult and rather late to appear.

Biochemical  markers like Neutropenia, Thrombocytopenia, Immature neutrophils (Band cells + myelocytes + metamyelocytes) to total neutrophils ratio (l/T) > 0.20,  C-reactive protein(CRP), neonatal procalcitonin, Interleukin (IL) 6 & IL 8, serum amyloid A, Tumor necrosis Factor (TNF) α have their own limitations and some more are in evaluative phase

Procalcitonin (PCT) is a prohormone secreted by most parenchymal tissues. Recent studies demonstrate that cord blood PCT levels could be used to discriminate between septic and nonseptic neonates at an early stage. The derived cutoff values of PCT used in the cord blood studies ranged from 0.5 to 1.22ng/mL.

Operating curves of PCT determined 0.6 ng/ml as the best cut-off (immuno‐chromatographic semiquantitative test). The sensitivity, specificity, and negative and positive predictive values were respectively 87.5%, 98.7%, 87.5%, and 98.7% for PCT.  It also presents good positive and negative likelihood ratios and appears to be more reliable than CRP. We have planned a retrospective observational study of the cord blood procalcitonin to use this as a screening tool in diagnosis of EONS. 
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