| CTRI Number |
CTRI/2024/04/065406 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of surfactant and surfactant with budesonide to reduce the incidence of chronic lung disease in a very preterm newborns - a randomised control trial |
|
Scientific Title of Study
|
Does surfactant mixed with budesonide in comparison with surfactant, reduce the incidence of BPD in very preterms- A Randomised control 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 |
Shaik Mohammed Munthakheem |
| Designation |
Senior Resident |
| Affiliation |
Government medical college |
| Address |
Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra 431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9620107364 |
| Fax |
|
| Email |
munthakheem93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L S Deshmukh |
| Designation |
Professor and Head |
| Affiliation |
Government medical college |
| Address |
Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra 431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9822478275 |
| Fax |
|
| Email |
deshmukhls@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaik Mohammed Munthakheem |
| Designation |
Senior Resident |
| Affiliation |
Government medical college |
| Address |
Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra 431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9620107364 |
| Fax |
|
| Email |
munthakheem93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college (GHATI) Aurangabad,Maharashtra 431001 |
|
|
Primary Sponsor
|
| Name |
Shaik Mohammed Munthakheem |
| Address |
Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra 431001 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Shaik Mohammed Munthakheem |
Government medical college (GHATI) |
Department of Neonatology, 2nd floor, Surgical building, government medical college (GHATI)
Aurangabad
MAHARASHTRA |
9620107364
munthakheem93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Govt Medical college aurangabad ( IEC-GMCA ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P22||Respiratory distress of newborn, (2) ICD-10 Condition: P27||Chronic respiratory disease originating in the perinatal period, (3) ICD-10 Condition: P522||Intraventricular (nontraumatic) hemorrhage, grade 3 and grade 4, of newborn, (4) ICD-10 Condition: P520||Intraventricular (nontraumatic) hemorrhage, grade 1, of newborn, (5) ICD-10 Condition: P521||Intraventricular (nontraumatic) hemorrhage, grade 2, of newborn, (6) ICD-10 Condition: P771||Stage 1 necrotizing enterocolitisin newborn, (7) ICD-10 Condition: P772||Stage 2 necrotizing enterocolitisin newborn, (8) ICD-10 Condition: P773||Stage 3 necrotizing enterocolitisin newborn, (9) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified, (10) ICD-10 Condition: Q250||Patent ductus arteriosus, (11) ICD-10 Condition: H351||Retinopathy of prematurity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Budesonide mixed with Surfactant |
Dose:
1.Bovine Surfactant (Neosurf,Cipla) 5ml/kg
2.Budesonide 0.25mg/kg
Frequency:
1st dose will be given within the first 6 hours of birth and second dose will be given 6 hours after the first dose as decided by the clinician
Route:
Endotracheal route via LISA/InSURE/ ET if already intubated
Total duration of intervention
birth to 48 hours of life |
| Comparator Agent |
Surfactant |
Dose:Bovine Surfactant (Neosurf,Cipla) 5ml/kg Frequency: 1st dose will be given within the first 6 hours of birth and second dose will be given 6 hours after the first dose as decided by the clinician Route: Endotracheal route via LISA/InSURE/ ET if already intubated Total duration of intervention birth to 48 hours of life |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
All inborn babies less than 30 weeks, weigth less than 1500 grams, age less than 48 hours, requiring invasive or non invasive respiratory support, clinical decision to give surfactant and consent obtained |
|
| ExclusionCriteria |
| Details |
Infants with major congenital anomalies, birth asphyxia (Apgar score less than 4 at 5 minutes after birth), who had prolonged resuscitation, and lethal cardiopulmonary disorder were excluded. |
|
|
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 |
| Death or BPD or BPD and Death |
Death or discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NEC,IVH,ROP,Sepsis,PDA, Use of post natal steriods |
Death or discharge |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/04/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 (RDS) in preterm infants is caused by a deficiency of pulmonary surfactant, which is necessary to reduce surface tension at alveoli. Increased surface tension, if untreated, may cause progressive airway collapse. Bronchopulmonary dysplasia (BPD) is one of the main chronic diseases of newborns born prematurely and, despite the development of medicine since its initial description more than 50 years ago, little has changed regarding the incidence of this disease.1-3 Compared with the conventional surfactant administration, surfactant mixed with budesonide was found to reduce - BPD
- PDA
- Post natal steriod use
- ROP
- NEC
- IVH
- Sepsis
- Duration of ventilation
- Duration of hospital stay
|