| 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
|
|
|
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
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified, |
|
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Intervention / Comparator Agent
|
|
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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 |
|
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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 (immunoâ€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. |