| CTRI Number |
CTRI/2025/02/080894 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Neonatal Pain Response To Various Heel Prick Devices -A Randomised Controlled Study conducted on neonatal nursery of Baroda Medical College |
|
Scientific Title of Study
|
Neonatal Pain Response To Various Heel Prick Devices -A Randomised Controlled Study |
| 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 Paresh Thakkar |
| Designation |
Additional Professor |
| Affiliation |
Govt Medical College Baroda |
| Address |
Department Of Paediatrics
Govt Medical College Baroda
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9426032150 |
| Fax |
|
| Email |
drpareshresearchandtrials@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navami S |
| Designation |
PG Resident |
| Affiliation |
Govt Medical College Baroda |
| Address |
Department Of Paediatrics
Govt Medical College Baroda
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9426032150 |
| Fax |
|
| Email |
navamiseena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paresh Thakkar |
| Designation |
Additional Professor |
| Affiliation |
Govt Medical College Baroda |
| Address |
Department Of Paediatrics
Govt Medical College Baroda
Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9426032150 |
| Fax |
|
| Email |
drpareshresearchandtrials@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Medical College , Baroda
Anandpura ,Vadodara ,390001 ,Gujrat |
| SELF SPONSORED |
|
|
Primary Sponsor
|
| Name |
Navami S |
| Address |
PG Resident
Department Of Paediatrics ,
Govt Medical College ,Baroda
Anandpura ,Vadodara ,Gujrat ,390001 |
| Type of Sponsor |
Other [self sponsored ] |
|
|
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 Paresh Thakkar |
Baroda Govt Medical College |
Neonatal & postnatal wards (EMNICU & IMNICU) of Department of Paediatrics ,Govt Medical College , Baroda
Anandpura ,Vadodara ,390001
Gujrat
Vadodara
GUJARAT |
9426032150
drpareshresearchandtrials@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F430||Acute stress reaction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
heel prick |
heel prick for random blood sugar estimation either by automatic lancet , mannual lancet or 26-gauge hypodermic needle ; lasting for less than 5 seconds |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
clinically stable neonates of gestational age more than 32 weeks & more than 1500 g undergoing heel prick for estimation of random blood sugar admitted in neonatal nursery & postnatal wards of Baroda Medical College |
|
| ExclusionCriteria |
| Details |
parents not consenting for participation , chidren requiring multiple pricks , sick neonates on ventilator support, in shock,perinatal asphyxia,neurological
abnormalities or congenital anomalies, and those with exposure to analgesic medications,
sedation or analgesia, and a major painful procedure done in the preceding 24 hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PIPP R SCORE TO ASSESS NEONATAL PAIN RESPONSE TO HEEL PRICK
|
IMMEDIATELY POST HEEL PRICK (1 TO 10 MINUTES ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AUDIBLE CRYING DURATION POST HEEL PRICK |
MEASURED IN MINUTES i.e 1 to 10 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
28/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
I would like to conduct a randomised controlled study to assess and compare the neonatal pain response to various heel prick devices in clinically stable neonates of gestational age more than 32 weeks and more than 1500g undergoing heel prick for estimation of random blood sugar admitted in neonatal nursery and postnatal wards of Baroda Medical College
|