| CTRI Number |
CTRI/2026/02/102973 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Choice of intravenous fluids for volume expansion in neonates with shock |
|
Scientific Title of Study
|
Volume expansion with Ringers Lactate versus Normal Saline in neonates with shock requiring fluid therapy an open labelled randomized controlled trial |
| Trial Acronym |
VeRN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Goudar |
| Designation |
DM Neonatology resident |
| Affiliation |
IMS and SUM HOSPITAL (SOA UNIVERSITY) |
| Address |
NICU, Ground floor, IMS and SUM Hospital,K8 Kalinga nagar, Shampur, Bhubaneswar, Khordha, Orissa
Khordha
ORISSA
751003
India |
| Phone |
9741515067 |
| Fax |
|
| Email |
gordo7n@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debasish Nanda |
| Designation |
Professor & HOD, Dept. of Neonatology |
| Affiliation |
IMS and SUM HOSPITAL (SOA UNIVERSITY) |
| Address |
NICU, Ground floor, IMS and SUM Hospital, K8 Kalinga Nagar, Shampur, Bhubaneswar, Khordha, Orissa
Khordha
ORISSA
751003
India |
| Phone |
9861422685 |
| Fax |
|
| Email |
debasishnanda@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Debasish Nanda |
| Designation |
Associate Professor, Dept. of Neonatology |
| Affiliation |
IMS and SUM HOSPITAL (SOA UNIVERSITY) |
| Address |
NICU, Ground floor, IMS and SUM Hospital, K8 Kalinga Nagar, Shampur, Bhubaneswar, Khordha, Orissa
Khordha
ORISSA
751003
India |
| Phone |
9861422685 |
| Fax |
|
| Email |
debasishnanda@soa.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IMS and SUM Hospital SOA University |
| Address |
IMS and SUM Hospital, K8 Kalinga nagar, Shampur, Bhubaneswar, Khordha, Orissa-751003 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neha Goudar |
IMS and SUM HOSPITAL (SOA UNIVERSITY) |
NICU, Ground floor, Department of Neonatology, IMS and SUM Hospital (SOA University), K-8, Kalinga nagar, Shampur, Bhubaneswar
Khordha
ORISSA |
9741515067
gordo7n@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, IMS AND SUM HOSPITAL (SOA UNIVERSITY) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I959||Hypotension, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline solution |
In neonates with shock requiring volume expansion, Normal Saline will be given at 10ml/kg over 30 minutes and will be assessed thereafter for improvement of shock or need for additional bolus/vasopressor upto 48 hours |
| Intervention |
Ringers Lactate solution |
In neonates with shock requiring volume expansion, Ringers lactate will be given at 10ml/kg over 30 minutes and will be assessed thereafter for improvement of shock or need for additional bolus/vasopressor upto 48 hours |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates born between 28 to 40 weeks of gestational age with 1st episode of shock |
|
| ExclusionCriteria |
| Details |
A.Critically sick and considered non-viable by clinicians
B.Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosus)
C.Chromosomal abnormalities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for vasopressor after Volume expansion with Ringer lactate as compared to Normal Saline. |
Upto 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for additional bolus of crystalloids. |
Upto 48 hours |
| Need for more than one vasopressor support |
Upto 48 hours |
| Duration of inotropes |
Discharge |
| All-cause mortality |
36 weeks PMA |
| Severe brain injury IVH grade 2 and above, PVL |
Discharge |
| Change in the lactate levels |
Upto 48 hours |
| Changes in bicarbonate levels |
Upto 48 hours |
| Changes in chloride levels. |
Upto 48 hours |
| Cardiac output assessment |
Baseline, 48 hours |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
22/02/2026 |
| 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="1"
Months="6"
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
|
Neonates who fulfil the inclusion criteria will be randomized after obtaining consent from parents. Babies requiring volume expansion will receive either Ringer’s Lactate or Normal Saline at 10ml/kg over 30-60 minutes and will be assessed after completion of the first fluid bolus for resolution of shock or if there is a need for another bolus/vasopressor like Dopamine or Dobutamine based on clinical criteria. Blood gas will be done at randomization to corroborate clinical findings and changes in blood gas components, like lactate and bicarbonate, will be documented. Cardiac output will be assessed before/during fluid therapy, and the response to fluid therapy will also be documented. All data will be entered on structured proforma.
The data will be presented as frequency and percentage for categorical variables. For continuous variables, we will report the mean with standard deviation or the median with interquartile range (IQR), depending on the distribution of the data. A Chi-square test will be used to compare two groups for categorical outcomes, while a Student’s t-test will be applied for continuous outcomes, where p values < 0.05 will be considered significant. Outcomes will be stratified as per the type of shock in the subgroup analysis. Additionally, logistic random effect regression will be used for binary outcomes, and linear random effect regression will be applied for continuous data outcomes. Data will be analysed using JAMOVI and R programme. |