| CTRI Number |
CTRI/2026/04/107962 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [INTRAVENOUS FLUID ADMINISTRATION] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess whether giving less fluid help newborn babies with breathing problems recover better. |
|
Scientific Title of Study
|
Evaluation of Efficacy of Restricted Fluid Management in Respiratory Distress Syndrome Neonates : A Randomised Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Chintala |
| Designation |
Junior Resident |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Pediatrics ,Jawaharlal Nehru Medical College,Sawangi Meghe ,Wardha,MAHARASTRA
442001,INDIA
Wardha MAHARASHTRA 442001 India |
| Phone |
09121320940 |
| Fax |
|
| Email |
Shalini.chintala123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr R J MESHRAM |
| Designation |
Associate Professor |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Pediatrics ,Jawaharlal Nehru Medical College,Sawangi Meghe ,Wardha,MAHARASTRA
442001,INDIA
Wardha MAHARASHTRA 442001 India |
| Phone |
9823763989 |
| Fax |
|
| Email |
rjmeshram@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr R J MESHRAM |
| Designation |
Associate Professor |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Pediatrics ,Jawaharlal Nehru Medical College,Sawangi Meghe ,Wardha,MAHARASTRA
442001,INDIA
Wardha MAHARASHTRA 442001 India |
| Phone |
9823763989 |
| Fax |
|
| Email |
rjmeshram@yahoo.com |
|
|
Source of Monetary or Material Support
|
| INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR) |
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
Sawangi Meghe Wardha,Maharastra ,India ,442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Shalini Chintala |
jawaharlal nehru medical college |
Department of Pediatrics ,Jawaharlal Nehru Medical College,Sawangi Meghe ,Wardha,MAHARASTRA
442001,INDIA Wardha MAHARASHTRA |
9121320940
Shalini.chintala123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional intravenous fluid administration |
Neonates randomized to the control arm will receive standard IV fluid therapy as per institutional NICU protocol. Total duration of intervention- 1 week. |
| Intervention |
Restricted intravenous fluid administration |
Neonates randomized to the intervention arm will receive restricted intravenous fluid therapy, defined as 70 perecnt of the conventional fluid requirement.totaal duration-1 week. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All Neonates with Respiratory Distress Syndrome. |
|
| ExclusionCriteria |
| Details |
Neonates with congenital malformations ,heart diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Respiratory Support is measured in hours from initiation to cessation of respiratory support (e.g., CPAP, mechanical ventilation) |
from birth to 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first enteral feeding
|
from birth to 28 days |
| Duration of NICU stay |
from birth to 28 days |
| Incidence of patent ductus arteriosus |
from birth to 28 days |
|
|
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)
|
20/04/2026 |
| 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
|
Respiratory Distress Syndrome is a leading cause of morbidity and mortality in neonates, particularly among preterm infants. It primarily results from surfactant deficiency, leading to reduced lung compliance, impaired gas exchange, and progressive respiratory failure. Despite advancements in neonatal care, including surfactant therapy and respiratory support, optimal fluid management in these neonates remains an area of ongoing clinical uncertainty. In current practice, conventional fluid management involves gradual escalation of intravenous fluid volumes during the first week of life. However, excessive fluid administration in neonates with RDS has been associated with adverse outcomes such as pulmonary edema, worsening respiratory function, prolonged need for ventilatory support, and increased risk of complications like patent ductus arteriosus, bronchopulmonary dysplasia, and intraventricular hemorrhage. These complications are thought to arise due to fluid overload contributing to increased interstitial lung water and impaired pulmonary mechanics. Restricted fluid management has been proposed as a potential strategy to mitigate these risks. By limiting fluid intake, it may help reduce pulmonary edema, improve lung compliance, and enhance oxygenation, thereby potentially shortening the duration of respiratory support and improving overall outcomes. However, there is limited high-quality evidence from randomized controlled trials to definitively establish the benefits and safety of such an approach in neonates with RDS. This study is designed as a prospective randomized controlled trial to compare restricted fluid management, 70 percent of conventional fluid intake with standard fluid therapy in neonates diagnosed with RDS. The trial aims to evaluate whether fluid restriction can reduce the duration of respiratory support, which is the primary outcome, while also assessing secondary outcomes such as time to enteral feeding, duration of NICU stay, incidence of PDA, and short-term morbidity and mortality at discharge. A total of 42 neonates will be enrolled and randomized into two groups. Clinical parameters, fluid balance, and laboratory values will be closely monitored to ensure safety and effectiveness. The study is expected to provide evidence on whether a restrictive fluid strategy can improve respiratory outcomes without increasing the risk of dehydration or metabolic complications. The findings of this trial may contribute to optimizing fluid management protocols in neonatal intensive care units and improving clinical outcomes in neonates with Respiratory Distress Syndrome |