| CTRI Number |
CTRI/2026/03/105101 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Early cord blood testing to predict brain injury after birth asphyxia in babies. |
|
Scientific Title of Study
|
Evaluating role of human cord blood CD34+ cells as a novel biomarker in perinatal asphyxia: A prospective 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 Nishant Banait |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Department of neonatology, MIHAN, Sumthana, Dahegaon
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9673998494 |
| Fax |
|
| Email |
nishantbanait@aiimsnagpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Banait |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Department of neonatology, MIHAN, Sumthana, Dahegaon
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9673998494 |
| Fax |
|
| Email |
nishantbanait@aiimsnagpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishant Banait |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Nagpur |
| Address |
Department of neonatology, MIHAN, Sumthana, Dahegaon
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9673998494 |
| Fax |
|
| Email |
nishantbanait@aiimsnagpur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences
Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Nishant Banait |
| Address |
Department of neonatology ,All India Institute Of Medical Sciences
Nagpur MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra
441108 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Amit Kumar |
Department of neonatology ,All India Institute Of Medical SciencesNagpur MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108 |
| Dr Ashwini Umredkar |
Department of radiology ,All India Institute Of Medical Sciences
Nagpur MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra
441108 |
| Dr Richa Juneja |
Department of pathologyy ,All India Institute Of Medical Sciences
Nagpur MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra
441108 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nishant Banait |
All India Institute Of Medical Sciences Nagpur |
IPD 303 & IPD 306, Department of neonatology, All India Institute Of
Medical Sciences Nagpur MIHAN, Nagpur,
Sumthana, Dahegaon, Maharashtra 441108
Nagpur
MAHARASHTRA |
9673998494
nishantbanait@aiimsnagpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All india istitute of medical sciences, Nagpur, Institutional ethics committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P916||Hypoxic ischemic encephalopathy [HIE], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
1.Cases:
1. 37 week and 0 day to 42week and 6 days gestational age and more than 1.8kgs
2. Evidence of asphyxia as defined by the presence of at least two of the following four criteria:
A. Apgar less than 5 at 10 minutes or continued need for resuscitation with positive pressure ventilation with or without chest compressions at 10 minutes of age
B. Any acute perinatal event that may result in HIE (abruption placenta, cord prolapse, severe foetal heart rate abnormality.).
C. Cord pH less than 7.1 or base deficit of 12 or more within 60 minutes of birth
D. If cord pH is not available, arterial/ capillary/ venous pH less than 7.1 or BE more than 12 mmol/L within 60 minutes of birth
3. Clinical signs of HIE
4. aEEG suggestive of HIE
2.Controls:
1.37 week and 0 day to 42week and 6 day gestational age and more than 1.8kgs
2. Normal cord blood gas analysis (pH more than 7.20, base deficit less than 16 mmol/L).
3. Apgar score more than 7 at 5 minutes.
|
|
| ExclusionCriteria |
| Details |
Cases:
1.Neonates with congenital anomalies or chromosomal abnormalities.
2.Neonates from multiple pregnancies.
3.Parents not giving consent for participation.
Controls
1.Neonates with congenital anomalies or chromosomal abnormalities.
2.Neonates from multiple pregnancies.
3.Maternal infections/ chorioamnionitis at the time of birth.
4.Presence of fetal distress.
5.Maternal gestational diabetes mellitus, hypertension.
6.Parents not giving consent for participation.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Association between CD34+ cell levels and HIE severity:
1.Comparison of CD34+ cell levels in umbilical cord blood between neonates with perinatal asphyxia who has HIE and neonates without perinatal asphyxia.
2.To compare CD34+ cell levels in term neonates with mild, moderate and severe HIE using Thompson scoring at 6 hours.
3.Correlation between CD34+ cell count and aEEG findings of patients with moderate to severe HIE
|
At birth, 1 hour of life , 6 hour of life then 6 houuly till 72 hours of life. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mortality: Evaluation of CD34+ cell levels & nRBCs as a predictor of mortality in neonates with moderate-to-severe HIE.
2. Neurodevelopmental Impairment: Correlation between CD34+ cell levels & neurodevelopmental outcomes at discharge (HNNE Score).
3. Neuroimaging: Correlation of CD34+ cell levels & nRBCs with MRI Brain & MR Spectroscopy findings between 8 to 14 days of life in cases with moderate to severe HIE.
4. Correlation of CD34+ cell levels & nRBCs with acute & chronic perinatal asphyxia.
|
At 1 hour of life, MRI before 14 days of life in cases. HNNE score at the time of discharge |
|
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Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
10/03/2026 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Neonatal hypoxic-ischemic encephalopathy (HIE) is a leading cause of neonatal morbidity and mortality, often resulting in long-term neurodevelopmental impairments. Early identification of HIE severity is important for timely intervention. CD34-positive (CD34+) hematopoietic stem cells, known for their regenerative and neuroprotective properties, may serve as a reliable novel biomarker for predicting HIE severity and outcomes as shown in recent study. Objective:
To evaluate the association between CD34+ cell levels in umbilical cord blood and the severity of HIE in term neonates. Secondary objectives include exploring correlations between CD34+ levels, clinical parameters (e.g., APGAR scores, cord pH), haematological markers (e.g., NRBC, TLC), and adverse outcomes such as mortality and neurodevelopmental impairment. Methods:
This case-control study will enroll term neonates with perinatal asphyxia who have HIE as cases and healthy term neonates without perinatal asphyxia as controls. Umbilical cord blood will be collected at birth to measure CD34+ levels using flow cytometry. Data on clinical parameters, laboratory markers, and outcomes will be analyzed. Statistical methods will include t-tests, ANOVA, correlation analysis, and logistic regression to determine the association between CD34+ levels and HIE severity and outcomes.
CD34+ cell levels could provide a novel early biomarker for assessing HIE severity and predicting adverse outcomes, potentially guiding therapeutic decisions and improving neonatal care.
|