| CTRI Number |
CTRI/2021/07/035104 [Registered on: 26/07/2021] Trial Registered Prospectively |
| Last Modified On: |
14/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY ON ANALGESIC EFFECTS DURING VACCINATION IN HEALTHY TERM INFANTS
|
|
Scientific Title of Study
|
A STUDY ON THE ANALGESIC EFFECTS OF DIRECT BREASTFEEDING AND 24 %SUCROSE SOLUTION AGAINST A CONTROL GROUP DURING VACCINATION IN HEALTHY TERM INFANTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AKHILA KURIAN |
| Designation |
Postgraduate student |
| Affiliation |
MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PAEDIATRICS
MOSC MEDICAL COLLEGE
KOLENCHERY
Ernakulam
KERALA
682311
India |
| Phone |
9400632516 |
| Fax |
|
| Email |
drakhilakurian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ISAC MATHAI |
| Designation |
Head of department |
| Affiliation |
MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE |
| Address |
Department of paediatrics
MOSC MEDICAL COLLEGE
KOLENCHERY
Ernakulam
KERALA
682311
India |
| Phone |
9447036732 |
| Fax |
|
| Email |
drisacmathai2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AKHILA KURIAN |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PAEDIATRICS
MOSC MEDICAL COLLEGE
KOLENCHERY
Ernakulam
KERALA
682311
India |
| Phone |
9400632516 |
| Fax |
|
| Email |
drakhilakurian@gmail.com |
|
|
Source of Monetary or Material Support
|
| MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
DR AKHILA KURIAN |
| Address |
DEPARTMENT OF PAEDIATRICS
MOSC MEDICAL COLLEGE
KOLENCHERY |
| Type of Sponsor |
Other [Self] |
|
|
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 AKHILA KURIAN |
MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE |
DEPARTMENT OF PAEDIATRICS
KOLENCHERY
PINCODE - 682311
Ernakulam
KERALA |
9400632516
drakhilakurian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy term infants coming to Paediatric OPD for infantrix Hexa vaccination at 6 weeks |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
24%sucrose solution administration |
In one of the three randomised groups, 24%sucrose solution is administered 2minutes prior to vaccination. This intervention is done only in one randomised group. |
| Comparator Agent |
Infantrix Hexa |
Randomising infants coming for infantrix Hexa vaccination into three groups. One group is control, the other is breast feed 1 hour prior to procedure and third is given 24%sucrose solution |
|
|
Inclusion Criteria
|
| Age From |
45.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
Term infants, who are exclusively or partially breastfed and attending the immunization clinic for infantrix Hexa(GSK) vaccination under 1 year of age (6weeks ) .
Healthy, developmentally appropriate infants born at 37to 42 weeks’ gestation, with birth weight
≥2.5 kg,
All infants should have been fed within three hours prior to the intervention, but shouldn’t have had a feed in the past 30 minutes. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA: Infants with a current illness
-unable to tolerate fluids by mouth
- with cerebral palsy where response to painful stimuli may be altered
-with perinatal asphyxia with congenital malformations and developmental delay |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome variable- acute behavioural pain response, will be assessed using a composite score obtained from the modified behavioural pain score for infants.
|
2 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of cry ,latency of onset(from administration to onset of cry) - Heart rate measurement prior(5min) and post administration at 5 minutes - SpO2 monitoring will also be done at 5 minutes before and after |
10min |
|
|
Target Sample Size
|
Total Sample Size="141"
Sample Size from India="141"
Final Enrollment numbers achieved (Total)= "149"
Final Enrollment numbers achieved (India)="149" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/07/2021 |
| Date of Study Completion (India) |
01/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized control trial of healthy Infants under 1 year of age coming for vaccination to paediatric OPD of MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE Children are randomised into 3 groups using computer generated block randomisation . Analgesic effect of 24%sucrose and breast feeding against a control group is assessed during vaccination. Pain is evaluated using modified behavioural pain scale (MBPS) Along with heart rate, Saturation monitoring as a secondary outcome Each group a sample size of 47 is expected So, total sample size of 141 together in all 3 groups |