| 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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [meakshay1111@gmail.com].
- 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.
- 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. |