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CTRI Number  CTRI/2020/08/027195 [Registered on: 18/08/2020] Trial Registered Prospectively
Last Modified On: 14/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   OBSERVATIONAL 
Study Design  Other 
Public Title of Study   Lactate Clearance And Neonatal Sepsis Score  
Scientific Title of Study   Lactate Clearance And Modified Sepsis Neonatal Score As Markers Of Adverse Outcomes In Neonates With Sepsis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHUBHIKA GARG 
Designation  JUNIOR RESIDENT PEDIATRICS 
Affiliation  ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Pediatrics Residents Duty Room Eras Lucknow Medical College and Hospital Lucknow

Lucknow
UTTAR PRADESH
263003
India 
Phone  8967834325  
Fax    
Email  shubhika1602@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MMA FARIDI 
Designation  Principal, CMS and Professor of Pediatrics 
Affiliation  ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL 
Address  Principals office Eras Lucknow Medical College and Hospital Lucknow

Lucknow
UTTAR PRADESH
263003
India 
Phone    
Fax    
Email  drmmafaridi@gmail.com  
 
Details of Contact Person
Public Query  
Name  SHUBHIKA GARG 
Designation  JUNIOR RESIDENT PEDIATRICS 
Affiliation  ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL 
Address  Department of Pediatrics Residents Duty Room Eras Lucknow Medical College and Hospital Lucknow

Lucknow
UTTAR PRADESH
263003
India 
Phone  8967834325  
Fax    
Email  shubhika1602@gmail.com  
 
Source of Monetary or Material Support  
Shubhika Garg Junior Resident Department of Pediatrics Eras Luknow Medical College and Hospital 
 
Primary Sponsor  
Name  SHUBHIKA GARG 
Address  Department of Pediatrics Junior Resident duty room ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL 
Type of Sponsor  Private medical college 
 
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 
SHUBHIKA GARG  ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL  Pediatric Department Residents Duty Room
Lucknow
UTTAR PRADESH 		 8967834325

shubhika1602@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ERAS INTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis, (2) ICD-10 Condition: A499||Bacterial infection, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil   nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  Neonates with a clinical diagnosis of sepsis, who are blood culture positive
or
Neonates with clinical diagnosis of sepsis with 2 or more of the following positive lab criteria [TLC<5000/mm3, low absolute neutrophil count, immature to total neutrophil ratio>0.2, CRP-positive]
 
 
ExclusionCriteria 
Details  Neonates with
Congenital abnormalities,
Those who received blood transfusion or infusion Ringer’s lactate prior to examination,
Neonates on 2nd line antibiotics,
Asphyxiated neonates
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality  Recruitment
6 hours
28 days or earlier 
 
Secondary Outcome  
Outcome  TimePoints 
To study complications of neonatal sepsis that might develop in infants with lactate clearance 10% and Modified Sepsis Neonatal Score≤10 who survive till 28days or earlier.  Recruitment, 6hours, 28days or earlier 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   25/08/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Neonatal sepsis is one of the major health problems in neonatal care. It has a high mortality rate of 18 per 1000 live births. To call a neonate in sepsis, a positive blood culture constitutes the gold standard. It is divided into 2 groups- Early onset sepsis(≤72hrs of life) and Late onset sepsis(>72hrs of life)

Blood lactate concentration is a marker of onset of tissue hypoxia, which is the risk factor for death in neonatal sepsis.

In practice there are various clinical scoring system for neonatal sepsis like CRIB(clinical risk index for baby score) II, SNAP(score for neonatal acute physiology)-II, SNAPPE(score for neonatal acute physiology-perinatal extension)-II, MSNS(modified sepsis neonatal score) for prediction of prognosis. In this study we are using MSNS score.

So we will take both these parameters to assess To study number of newborn deaths occurring in infants with lactate clearance <10% and Modified Sepsis Neonatal Score≤10 till 28days or earlier.

Neonates upto 7days will be taken in for study who fulfill the inclusion criteria and outcome evaluation is done at recruitment and 6hours later of first starting the treatment

 
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