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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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