| CTRI Number |
CTRI/2017/04/008427 [Registered on: 27/04/2017] Trial Registered Prospectively |
| Last Modified On: |
26/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check for neonatal infections using saliva |
|
Scientific Title of Study
|
Pilot study to identify potential saliva-based biomarkers for diagnosis of neonatal sepsis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kishore R Kumar |
| Designation |
Chief consultant neonatalogist and paediatrician |
| Affiliation |
Kids Clinic India Pvt. Ltd (Cloudnine Hospital) |
| Address |
#1533, 9TH Main, 3rd Block, Jayanagar, Bangalore 560011
Bangalore
KARNATAKA
560011
India |
| Phone |
9900155001 |
| Fax |
|
| Email |
drkishore@cloudninecare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishore R Kumar |
| Designation |
Chief consultant neonatalogist and paediatrician |
| Affiliation |
Kids Clinic India Pvt. Ltd (Cloudnine Hospital) |
| Address |
#1533, 9TH Main, 3rd Block, Jayanagar, Bangalore 560011
Bangalore
KARNATAKA
560011
India |
| Phone |
9900155001 |
| Fax |
|
| Email |
drkishore@cloudninecare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishore R Kumar |
| Designation |
Chief consultant neonatalogist and paediatrician |
| Affiliation |
Kids Clinic India Pvt. Ltd (Cloudnine Hospital) |
| Address |
#1533, 9TH Main, 3rd Block, Jayanagar, Bangalore 560011
Bangalore
KARNATAKA
560011
India |
| Phone |
9900155001 |
| Fax |
|
| Email |
drkishore@cloudninecare.com |
|
|
Source of Monetary or Material Support
|
| Spot Healthcare Solutions Pvt.Ltd
Spot Healthcare Solution Pvt Ltd
Address: C-CAMP, NCBS-TIFR, GKVK Campus,
Bellary Road, Bengaluru 560065 |
|
|
Primary Sponsor
|
| Name |
Spot Healthcare Solutions Pvt Ltd |
| Address |
Spot Healthcare Solution Pvt. Ltd.
C-camp, N.C.B.S.-T.I.F.R., G.K.V.K. campus,
Bellary Road, Bengaluru 560065 |
| Type of Sponsor |
Other [For profit medical diagnostics company] |
|
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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 Kishore R Kumar |
Kids Clinic India Pvt Ltd |
#1533, 9th Main, 3rd Block, Jayanagar, Bangalore 560011
Bangalore
KARNATAKA |
9900155001
drkishore@cloudninecare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
neonates, showing clinical symptoms for sepsis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
The inclusion criteria will include all neonate who show clinical symptoms for sepsis (i.e any two of the following symptoms: respiratory distress, temperature fluctuation, diarrhea, reduced movements, reduced sucking, seizures, bradycardia, swollen belly area, heart rate>160). A hematological sepsis screen (as per section 8.4.2) and blood culture will be conducted.
The obtained sample groups will be categorized in following sections
1. Serum samples showing positive results for sepsis screen and positive results for blood culture
2. Serum samples showing positive results for sepsis screen but negative results for blood culture
Diagnosis of sepsis will be confirmed for neonates showing positive result for sepsis screen and a positive result for blood culture.
CONTROL GROUP: 50 age and sex matched healthy neonates (showing no clinical symptom for sepsis) will be recruited as the control group for this study. |
|
| ExclusionCriteria |
| Details |
Neonates who exhibit clinical symptoms for or have been identified with the following will be excluded from this study
1. Congenital malformation
2. Intraventricular bleed
3. Chronic lung disease
4. Perinatal asphyxia
5. Meconium aspiration syndrome
6. Chromosomal malformations |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Positive predictive value and negative predictive value of potential biomarkers for neonatal sepsis. |
August 2017 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Biomarker detection based point-of-care test for neonatal sepsis screening. |
December 2017 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/05/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The objective of this study is to establish correlation between the elevated salivary levels of CRP, IL-6, IL-8 and IL-10 to the occurrence of neonatal sepsis. Also, the sensitivity, specificity, positive predictive value and negative predictive value of these test levels would be established after comparison of the results against blood culture result. Available literature provides physiological levels for the said biomarkers in serum samples of neonates diagnosed with sepsis. However, no structured study has been done to identify these levels in salivary samples of the neonate. This study will aim at identifying the physiological levels and limit of detection of said salivary biomarkers to establish their usage in point-of-care diagnostics.Once the proposed tests are completed, we aim to incorporate the results to manufacture and distribute such a point-of-care diagnostic device for the public health system.
Preterm and low birth weight babies often show only subtle and unspecific symptoms of sepsis. This leads to delay in diagnosis of late onset sepsis and can often be overlooked by mothers or volunteer health workers. The absence of well-equipped pathology labs and trained pathologists adds to the complication of diagnosing and treating sepsis within time. Many biomarkers that can be used as a good prognostic and diagnostic biomarker for systemic infections are found in the saliva. These include cytokines (TNF-alpha, IL-1, IL-2, IL-6, IL-8), multiple antimicrobial proteins, acute phase reactants and immunoglobins. We are conducting this study for detection of several salivary biomarkers which can be utilized for detection of sepsis in neonates.Scope of the study: The scope of this study is limited to collection of saliva and blood samples from neonates suspected with sepsis (50 neonates) and a control group (50 neonates) to study the levels of CRP, IL-6 and IL-8 in saliva samples and comparing the results with the predictions of blood culture and sepsis screen.
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