| 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
|
|
|
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
|
|
|
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. |