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CTRI Number  CTRI/2024/10/075912 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   To determine the levels of high sensitivity cardiac troponin I in newborns with birth asphyxia  
Scientific Title of Study   ASSOCIATION OF HIGH SENSITIVITY CARDIAC TROPONIN I LEVELS IN NEW BORN WITH BIRTH ASPHYXIA IN PREDICTING EARLY MYOCARDIAL INJURY - A ONE YEAR HOSPITAL BASED CASE CONTROL STUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikhil Reddy P V 
Designation  RESIDENT, MD Paediatrics 
Affiliation  Jawaharlal Nehru Medical College,KLE University 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  7338254999  
Fax    
Email  nikhilrpv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veeresh Manvi 
Designation  PROFESSOR 
Affiliation  Jawaharlal Nehru Medical College,KLE University 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9164000009  
Fax    
Email  manviveeresh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Veeresh Manvi 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College,KLE University 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9164000009  
Fax    
Email  manviveeresh@gmail.com  
 
Source of Monetary or Material Support  
KLEs Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, KLE University,nehru nagar, Belagavi, karnataka 590010 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College KLE University Belagav 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road, Belgaum, Karnataka, 590010 
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 
Dr Nikhil Reddy P V  Dr Prabhakar kore hospital and medical research institute, JNMC, KLE  Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road Belgaum KARNATAKA
Belgaum
KARNATAKA 		 7338254999

nikhilrpv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I999||Unspecified disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  all newborns with histroy of birth asphyxia or not cried after birth or needing prolonged resuscitation 
 
ExclusionCriteria 
Details  1) Neonates with intrauterine infections or persistent pulmonary hypertension and congenital heart disease.
2) Infants for whom informed consent was not obtained as well as the infants to which parents/guardians have not given consent.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the values of high sensitivity cardiac troponin I in neonates born with birth asphyxia.  The study will be conducted over a span of one
year.
 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate between troponin I level and echocardiography in newborns with birth asphyxia.  The study will be conducted over a span of one
year. 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   01/11/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  through email nikhilrpv@gmail.com

  6. For how long will this data be available start date provided 17-06-2024 and end date provided 17-06-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Perinatal asphyxia is one of the leading causes of early neonatal mortality and according to WHO it accounts to estimated 900,000 deaths worldwide each year. The ICD-10 WHO definition of birth asphyxia as failing to initiate and sustain breathing at birth is specified by the two categories of codes: P20 “intrauterine hypoxia” and P21 “birth asphyxia”.

·       In India, the incidence of perinatal asphyxia is as high as 8.4% (considering the definition of birth asphyxia as Apgar score of < 7 at 1 min). Perinatal asphyxia is one of the leading causes of neonatal mortality (28%) in our country and it is the most common and important cause of preventable cerebral injury occurring in the neonatal period. 

·       Neonatal asphyxia results in low foetal tissue perfusion, hypoxic ischemic injury, hypercapnia, and acidosis and is potentially fatal. survivors from neonatal asphyxia can suffer from morbidities such as motor and cognitive deficits that originate from cerebral hypoxia ischemia. 

Troponin, a protein complex consisting of I, T and C subunits, is located at the actin filaments of the myocardium and is essential for calcium-mediated muscle contraction. Troponin I and T are cardiac-specific subunits and markers of myocardial damage.

·       several studies have demonstrated that troponin-I is a good marker of myocardial dysfunction and early death in infants with HIE.

·       Troponin I levels in the blood are very low (<30 pg/ml in newborns) but injuries to the heart can cause the levels to increase significantly. Troponin I is a commonly used cardiac biomarker that may be useful for determining whether patients have perinatal asphyxia. 

·       The early diagnosis of the myocardial injury can limit the mortality associated with neonatal asphyxia.

·       Aim of the study is to estimate the levels of high sensitivity cardiac troponin I in newborns with birth asphyxia and to correlate the findings with echocardiography.

·       In patients with perinatal asphyxia, cardiac output is directed from less vital organs (liver, kidneys, and intestines) toward more critical organs such as the brain, heart, and adrenal gland due to hypoxia. 

·       Bradycardia develops rapidly with acute hypoxia and persists as acidosis becomes more severe; blood pressure is normal at this stage due to peripheral vasoconstriction and the redistribution of cardiac output toward vital organs.

·       If asphyxia continues, blood pressure drops, and ischemia occurs in the vital organs. low heart rate due to asphyxia and acidosis and the subsequent decrease in myocardial contractility due to ischemic cardiac injury reduce ventricular output and stroke volume. with reduced cardiac output, coronary perfusion decreases, and myocardial damage occurs. 

 


 
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