FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/106298 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To evaluate the underlying etiologies, clinical characteristics and prognostic factors associated with thrombocytopenia in neonates admitted to the neonatal intensive care unit in a rural tertiary care hospital. 
Scientific Title of Study   Clinico-etiological Profile of Neonatal Thrombocytopenia in a Tertiary Care NICU 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Palagani Akshay 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Room no. G10, Yashoda boys hostel, Jawaharlal Nehru Medical College, Sawangi, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7448681111  
Fax    
Email  meakshay1111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sham Lohiya 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College 
Address  No.16, Department of Pediatrics, Jawaharlal Nehru Medical College, Sawangi, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8098842537  
Fax    
Email  Sham.lohiya19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Palagani Akshay 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Room no. G10, Yashoda boys hostel, Jawaharlal Nehru Medical College, Sawangi, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7448681111  
Fax    
Email  meakshay1111@gmail.com  
 
Source of Monetary or Material Support  
DMIHER, Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharastra, India, 442107  
 
Primary Sponsor  
Name  Palagani Akshay 
Address  G10, Yashoda boys hostel, Sawangi, Wardha, 442001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Indian Council of Medical Research  Ansari nagar, East New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Palagani Akshay  Acharya Vinobabhave Rural Hospital  Department of Neonatology, Department of Pediatrics, 2nd floor, JNMC, Sawangi, Wardha
Wardha
MAHARASHTRA 
7448681111

meakshay1111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, DMIHER (DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P610||Transient neonatal thrombocytopenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Neonates with platelet counts less than 150,000 documented on at least one occasion during NICU stay

Both inborn and outborn neonates admitted to the NICU 
 
ExclusionCriteria 
Details  Neonates with known congenital or genetic thrombocytopenia syndromes (e.g., Wiskott–Aldrich syndrome, TAR syndrome) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the underlying etiologies, clinical characteristics and prognostic factors associated with thrombocytopenia in neonates admitted to the NICU  Prenatal, Natal and Post natal period of less than 28 days.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
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)   24/03/2026 
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   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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

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

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [meakshay1111@gmail.com].

  6. For how long will this data be available start date provided 24-03-2026 and end date provided 15-07-2040?
    Response - Immediately following publication. No end date.

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

Neonatal thrombocytopenia, defined as a platelet count below 150,000 per µL, is one of the most common hematological abnormalities seen in neonatal intensive care units, particularly among preterm and low birth weight infants. Early identification and appropriate management are important, as severe thrombocytopenia can increase the risk of bleeding and contribute to adverse clinical outcomes.

This prospective study will include 385 neonates diagnosed with neonatal thrombocytopenia who are admitted to a rural tertiary care hospital over a period of two years. The study aims to document maternal, perinatal, and neonatal risk factors associated with the condition. In addition, thrombocytopenia will be categorized according to the time of onset and severity in order to better understand its clinical patterns.

Clinical outcomes such as bleeding manifestations, duration of NICU stay, and mortality will also be evaluated. Particular attention will be given to the indications for platelet transfusion and the outcomes following transfusion, as current neonatal practice often lacks clear and standardized guidelines in this area.

By identifying common causes and potential prognostic markers of neonatal thrombocytopenia, the study seeks to support earlier diagnosis and more rational management. The findings may help guide evidence-based transfusion practices and contribute to the development of practical management protocols suited for rural NICU settings. Ultimately, this research aims to help reduce morbidity and mortality among affected neonates while also providing baseline data that may support future neonatal health research and policy development.

 
Close