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CTRI Number  CTRI/2024/05/067736 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 03/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of inhaled budesonide for reducing oxygen requirement in neonates with respiratory distress 
Scientific Title of Study   Efficacy of inhaled budesonide for reducing oxygen requirement in neonates with respiratory distress 
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 Mohit Kumar Soni 
Designation  Post graduate student in department of pediatrics, University college of medical sciences, Delhi 
Affiliation  University College of Medical Sciences and GTB hospital, Delhi 
Address  Department of Pediatrics, UCMS and GTB Hospital, Dilshad garden, Delhi-110095

North East
DELHI
110095
India 
Phone  9999366406  
Fax    
Email  dr.mksoni9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prerna Batra 
Designation  Director Professor in department of pediatrics, University college of medical sciences, Delhi 
Affiliation  University College of Medical Sciences and GTB hospital, Delhi 
Address  Department of Pediatrics, UCMS and GTB Hospital, Dilshad garden, Delhi-110095

North East
DELHI
110095
India 
Phone  9958672759  
Fax    
Email  drprernabatra@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohit Kumar Soni 
Designation  Post graduate student in department of pediatrics, University college of medical sciences, Delhi 
Affiliation  University College of Medical Sciences and GTB hospital, Delhi 
Address  Department of Pediatrics, UCMS and GTB Hospital, Dilshad garden, Delhi-110095

North East
DELHI
110095
India 
Phone  9999366406  
Fax    
Email  dr.mksoni9@gmail.com  
 
Source of Monetary or Material Support  
UCMS and GTB Hospital, Dilshad Garden, Delhi-110095, India 
 
Primary Sponsor  
Name  UCMS and GTB Hospital 
Address  UCMS and GTB Hospital, Dilshad Garden, Delhi-110095 
Type of Sponsor  Government 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 
Dr Mohit Kumar Soni  UCMS and GTB Hospital  Extra mural Neonatal Intensive Care Unit (NICU),Third floor, MCH Building, Dilshad Garden, Delhi-110095
North East
DELHI 
9999366406

dr.mksoni9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Human Research (IEC-HR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Budesonide inhalation  Subject will receive budesonide inhalation by nebulization every 12 hours for 3 days starting on day 4 of admission 
Comparator Agent  Sterile water  Subject will receive sterile water nebulization every 12 hours for 3 days starting on day 4 of admission 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All neonates (more than 34 weeks) up to 28 days of life with respiratory distress requiring an FiO2 more than 30 percent on day 4 of admission admitted in extra-mural NICU. 
 
ExclusionCriteria 
Details  1.Neonates who have non respiratory cause of respiratory distress (including congenital heart disease, Severe birth asphyxia, Polycythemia, Hypoglycemia etc.)
2.Neonates with Visible Gross Congenital Anomalies.
3.Neonates requiring exogenous surfactant. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean duration of oxygen requirement  randomization to day of discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Mean Downes score  At enrollment and then every 12 hours till 72 hours of budesonide nebulization 
Proportion of patients expired  randomization to day of expiry 
Mean duration of NICU and hospital stay  randomization to day of discharge 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/06/2024 
Date of Study Completion (India) 01/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/09/2025 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

This study has been designed to asses the efficacy of inhaled budesonide in reducing oxygen requirement in neonates with respiratory distress. Neonates with respiratory distress receiving inhaled budesonide will be compared with those receiving placebo and duration of oxygen requirement in two groups will be compared. Respiratory distress is one of most common reasons a neonate is admitted to the neonatal intensive care unit. Indian National Neonatal-Perinatal Database reported significant morbidity associated with neonates developing respiratory distress. Irrespective of the cause, lack of proper management of neonates with respiratory distress can result in respiratory failure and cardio pulmonary arrest. Oxygen therapy is an important part in management of neonates with respiratory distress but despite beneficial effect of oxygen therapy , long term oxygen therapy has shown to cause toxicity with evidence suggesting development of Bronchopulmonary dysplasia (BPD) and retinopathy of prematurity (ROP) in neonates on long term oxygen therapy. Budesonide is potent topical anti-inflammatory agent with powerful effects on respiratory system. It promotes production of anti-oxidant enzymes and can reduce bronchial and pulmonary edema. It also has anti inflammatory action by reducing production of anti inflammatory cytokines. .Severity of lung injury as indicated by oxygen dependency also reduced after administration of steroid. There is paucity of data on use of budesonide as first line agent in neonates with respiratory distress. Few studies have described the role of budesonide in neonates with Respiratory Distress Syndrome (RDS), Meconium Aspiration Syndrome (MAS), Transient Tachypnea of Newborn (TTN) and Bronchopulmonary Dysplasia (BPD) in reducing oxygen dependency and clinical improvement and the results have been mostly promising. Therefore, through this study, we propose to evaluate efficacy of inhaled budesonide in reducing oxygen dependency in neonates with Respiratory distress.


 
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