| CTRI Number |
CTRI/2022/03/041453 [Registered on: 29/03/2022] Trial Registered Prospectively |
| Last Modified On: |
27/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Surfactant are alveolar surface reducing agents,used in preterm baby having lower pool surfactant i.e. respiratory distress syndrome. Sedation and pain reducing drug administration during surfactant therapy by less invasive technique will be assessed in this trial. |
|
Scientific Title of Study
|
Fentanyl versus placebo before less invasive surfactant administration: A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bijan Saha |
| Designation |
Associate professor |
| Affiliation |
Institute of PostGraduate Medical Education and Research and SSKM Hospital |
| Address |
Department of Neonatology Institute of PostGraduate Medical Education and Research and SSKM Hospital Kolkata700020 India
Kolkata
WEST BENGAL
700020
India |
| Phone |
09051389120 |
| Fax |
|
| Email |
bijansaha18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bijan Saha |
| Designation |
Associate professor |
| Affiliation |
Institute of PostGraduate Medical Education and Research and SSKM Hospital |
| Address |
Department of Neonatology Institute of PostGraduate Medical Education and Research and SSKM Hospital Kolkata700020 India
WEST BENGAL
700020
India |
| Phone |
09051389120 |
| Fax |
|
| Email |
bijansaha18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bijan Saha |
| Designation |
Associate professor |
| Affiliation |
Institute of PostGraduate Medical Education and Research and SSKM Hospital |
| Address |
Department of Neonatology Institute of PostGraduate Medical Education and Research and SSKM Hospital Kolkata700020 India
WEST BENGAL
700020
India |
| Phone |
09051389120 |
| Fax |
|
| Email |
bijansaha18@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER SSKM HOSPITAL SSKM Hospital Rd Bhowanipore Kolkata West Bengal 700020 |
|
|
Primary Sponsor
|
| Name |
IPGMER SSKM HOSPITAL |
| Address |
244 AJC Bose Road Kolkata 700020 |
| 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 Bijan Saha |
evel III Neonatal Care Unit Department of Neonatology IPGMER SSKM HOSPITAL |
Department of neonatology 2nd floor NICU 244 AJC Bose Road Kolkata 700020
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
09051389120
bijansaha18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME & R Research Oversight Comitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl administration during Less Invasive Surfactant Administration |
Patients having RDS who required FiO2 more than 30 % on Noninvasive positive pressure ventilation to maintain SpO2 90-95% in first 6 hours of life will be randomised to receive surfactant by LISA technique either by sedation with fentanyl or not . Intravenous fentanyl (1 mcg/kg over 2 minute) will be used for sedation during the LISA procedure and will be given before the procedure . |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
Preterm baby with gestational age between 28 to 34 weeks diagnosed with RDS will enroll in this study . RDS will be diagnosed clinically initially and later confirm by chest X ray .
A written informed consent will be obtained from the parents of the baby for participation in the study |
|
| ExclusionCriteria |
| Details |
Baby with major congenital anomaly .
Perinatal asphyxia (cord blood pH<7.2).
Intubated at delivery room.
Alternative cause of respiratory distress.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the need for mechanical ventilation from the LISA procedure onwards up to 72 h of life. |
The primary outcome is the need for mechanical ventilation from the LISA procedure onwards up to 72 h of life. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of laryngoscopy attempts during the procedure
Complications occurring during and after the procedure SpO2 80 percentage hypotension with mean below gestational age bradycardia 100 bpm
Incidence of hsPDA
IVH above grade3
Broncho Pulmonary Dysplasia
Retinopathy of Prematurity requiring treatment
Culture positive sepsis
Necrotizing Enterocolitis above stage 3
Rate of feed intolerance
Gastrointestinal perforation confirmed on roentgenogram or surgical exploration
|
3month |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
31/03/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
For all nonemergent neonatal ventilation,premedicarion is considered mandatory.Awake laryngoscopy is known to be painful and associated with many adverse events.There is still no concensus on whether or not to use sedation during LISA. With sedation LISA procedure become smooth and sucessful but it might compromise the infants respiratory drive which is a prerequisite for LISA. This study will therefore be conducted to determine the efeects of fentanyl on the requirement of mechanical ventilation in the 72hr following the procedure in infants with RDS. |