| CTRI Number |
CTRI/2024/09/073301 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing dexmedtomidine with fentanyl infusion in better sedation in
preterm neonates- a randomized control trial |
|
Scientific Title of Study
|
Comparing dexmedtomidine vs fentanyl infusion in effective sedation in
preterm neonates- a randomized 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 |
Dr Aritra Ray |
| Designation |
Consultant |
| Affiliation |
Neotia Getwel Healthcare Centre |
| Address |
Department of Neonatology, Division NICU , room no 205
SILIGURI, P.O - Matigara , Darjiling
SILIGURI,
P.O - Matigara ,Dist -Darjeeling
Darjiling
WEST BENGAL
734010
India |
| Phone |
9641632917 |
| Fax |
|
| Email |
aritraray.sunny1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aritra Ray |
| Designation |
Consultant |
| Affiliation |
Neotia Getwel Healthcare Centre |
| Address |
Department of Neonatology, Division NICU , room no 205
SILIGURI,
P.O - Matigara ,Dist -Darjeeling
SILIGURI,
P.O - Matigara ,Dist -Darjeeling
Darjiling
WEST BENGAL
734010
India |
| Phone |
9641632917 |
| Fax |
|
| Email |
aritraray.sunny1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aritra Ray |
| Designation |
Consultant |
| Affiliation |
Neotia Getwel Healthcare Centre |
| Address |
Department of Neonatology, Division NICU , room no 205
SILIGURI,
P.O - Matigara ,Dist -Darjeeling
SILIGURI,
P.O - Matigara ,Dist -Darjeeling
Darjiling
WEST BENGAL
734010
India |
| Phone |
9641632917 |
| Fax |
|
| Email |
aritraray.sunny1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neotia Getwel Healthcare Centre,Siliguri,Darjeeling, WEST BENGAL-734010, |
|
|
Primary Sponsor
|
| Name |
Institute Neotia Getwel Healthcare Centre Dept of Neonatology |
| Address |
Neotia Getwel Healthcare Centre
SILIGURI, DARJEELING, WEST BENGAL- 734010, INDIA |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Aritra Ray |
Neotia Getwel Healthcare Centre |
Department of Neonatology, Division NICU , room no 205 Darjiling WEST BENGAL
Darjiling
WEST BENGAL
Darjiling
WEST BENGAL |
9641632917
aritraray.sunny1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Neotia Getwel Healthcare Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P28||Other respiratory conditions originating in the perinatal period, (2) ICD-10 Condition: P22||Respiratory distress of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedtomidine therapy |
dexmedtomidine therapy for effective pain relief and sedation in preterm neonates requiring pharmacotherapy for pain relief with NPASS more than 3,started with dose of 0.2 mcg/kg/hr and increased 0.2 mcg/kg/hr every 2-4 hrly from 0.2to max up to 1.4mcg/kg /hr depending on the pain score based on whether adequate sedation was achieved or not. |
| Comparator Agent |
Fentanyl therapy |
Fentanyl therapy for effective pain relief and sedation in preterm neonates requiring pharmacotherapy for pain relief with NPASS more than 3,started with a dose of 1 mcg/kg/hr and increased 0.5 mcg/kg/hr every 2-4 hrly from 1to max upto 4mcg/kg /hr depending on the pain score based on whether adequate sedation was achieved or not. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
preterm (28-37 weeks),post natal age less than 28 days
Requiring Respiratory support
Requiring pain management with pharmacotherapy as per Pain score (NPASS) more than 3
|
|
| ExclusionCriteria |
| Details |
Severe Neurological Issue
Congenital Anomaly
Any contraindication for starting pain pharmacotherapy (No intestinal peristaltic sounds, Hypotension ,Bradycardia)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cumulative Duration of Sedation |
at 1 wk after randomization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of Respiratory support |
at 1 wk and 2wk after randomization |
| Late onset sepsis |
any time prior to discharge |
| Requiring Adjunctive sedative medication |
any time prior to discharge |
| With drawl symptoms |
any time prior to discharge |
| Sedative medication stopped prematurely due to side effects |
any time prior to discharge |
| Days to Reach full feed |
at 1 wk and 2 wk and 3 wk |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/09/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
4.
AIMS & OBJECTIVE:-
a. AIM:- Comparing
Dexmedtomidine vs Fentanyl infusion in
Effective sedation in Preterm Neonates-A Randomized Control Trial
Consent-
Parents or legally acceptable representative (LAR) of
newborns meeting eligibility criteria will approached for informed consent. An
information sheet providing the details of the study will be provided to the
parents/LAR Parents are free not to participate, or to withdraw their child
from the study at any point of time and no coercion will be involved.
b.
OBJECTIVE:-
PRIMARY Cumulative Duration of Sedation
SECONDARY 1. Duration of Respiratory support
2. Late onset sepsis
3. Requiring Adjunctive sedative medication
4. With drawl symptoms prevalence/duration.
5. Sedative medication stopped prematurely due to side effects
6. Days to Reach full feed
5.
MATERIALS AND METHOD
a. TYPE OF STUDY- RANDOMISED CONTROL TRIAL
b. STUDY AREA- Neonatal intensive care unit, Neotia getwel
multispeciality hospital
c. STUDY PERIOD – 1 Year
d. STUDY
POPULATION-
INCLUSION : preterm (28-37 weeks),post
natal age< 28 days
Requiring
Respiratory support
Requiring pain
management as per Pain score (NPASS) >3
EXCLUSION : Severe Neurological
Issue
Congenital
Anomaly
Any
contraindication for starting pain pharmacotherapy (No intestinal
peristaltic sounds, Hypotension
,Bradycardia)
|