| CTRI Number |
CTRI/2023/09/057567 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
05/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Salbutamol in treatment of TTNB- A RCT STUDY |
|
Scientific Title of Study
|
A randomized controlled trial of the efficacy of inhaled salbutamol with standard therapy vs standard therapy alone for treatment of transient tachypnoea of newborn TTNB |
| Trial Acronym |
NOT APPLICABLE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Safquat Jalil |
| Designation |
JR1 Resident Paediatrics |
| Affiliation |
INSTITUTE OF NAVAL MEDICINE |
| Address |
Department of paediatrics, INHS ASVINI
INSTITUTE OF NAVAL MEDICINE, Colaba MUMBAI 400005
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9831046748 |
| Fax |
|
| Email |
sj.ipgmer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof (Dr) Vivek Bhat |
| Designation |
Prof & HOD Department of Pediatrics |
| Affiliation |
INSTITUTE OF NAVAL MEDICINE |
| Address |
Department of Pediatrics, INHS ASVINI,
INSTITUTE OF NAVAL MEDICINE, COLABA, MUMBAI 400005
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9592296155 |
| Fax |
|
| Email |
drbhatvivek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Safquat Jalil |
| Designation |
JR1 Resident Paediatrics |
| Affiliation |
INSTITUTE OF NAVAL MEDICINE |
| Address |
Department of pediatrics, INHS ASVINI
INSTITUTE OF NAVAL MEDICINE, COLABA MUMBAI 400005
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9831046748 |
| Fax |
|
| Email |
sj.ipgmer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics, INHS ASVINI, INSTITUTE OF NAVAL MEDICINE, COLABA , Mumbai 400005 |
|
|
Primary Sponsor
|
| Name |
Department of pediatrics INHS ASVINI |
| Address |
INSTITUTE OF NAVAL MEDICINE
INHS ASVINI
COLABA
MUMBAI 400005 |
| 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 Safquat Jalil |
Neonatal intensive care unit |
INHS ASVINI
INSTITUTE OF NAVAL MEDICINE, COLABA
MUMBAI 400005
Mumbai
MAHARASHTRA |
9831046748
sj.ipgmer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INHS ASVINI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline ( 0.9 % NaCl) |
nebulization with normal saline at rate of 0.15 ml/kg/dose every 6 hours for a duration till resolution of symptoms or 120 hours whichever is longer. |
| Intervention |
Salbutamol |
nebulization with salbutamol at rate of 0.15ml/kg/hour every 6 hours for a duration till resolution of symptoms or 120 hours whichever is longer. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
respiratory distress in NBB born within 6 hours of their birth |
|
| ExclusionCriteria |
| Details |
Gross congenital anomaly
Neonates born through meconium stained liqour
Any birth trauma
Any h/o birth asphyxia ( APGAR score < 6 at 1 min after birth)
Neonatal sepsis
Radiological finding consistent with pneumonia
Presence of PPHN
RDS of prematurity
Metabolic disorder like dysglycemia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to observe any reduction of oxygen therapy duration in interventional group as compared to placebo group |
Outcome will be assessed after intervention at an interval of every 30 min, 1 hour and then every 2 hour subsequently till resolution of symptoms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe reduction in hospital stay & early initiation of feeds |
To observe reduction in hospital stay from the baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
16/09/2023 |
| 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 Applicable |
| 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
|
NBB developing respiratory distress within 6 hours of birth, without any other comorbidities (exclusion criteria) will be diagnosed as TTNB and given standard treatment of TTNB. Among them half will be assigned intervention group which will be nebulization with salbutamol every 6 hourly and will assesed with DOWNE score and placebo group will be given nebulization with normal saline. Result will be tabulated on the basis duartion required to wean off from oxygen therapy |