| CTRI Number |
CTRI/2010/091/000426 [Registered on: 11/05/2010] |
| Last Modified On: |
28/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Vaccination order and Pain response in Newborns |
Scientific Title of Study
Modification(s)
|
Pain response in newborns to the order of injecting BCG and Hepatitis-B vaccines |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
SR Ravikiran |
| Designation |
|
| Affiliation |
|
| Address |
Assistant Professor, Department of Pediatrics
KVG Medical College
Not Applicable
N/A
574327
India |
| Phone |
9480238528 |
| Fax |
|
| Email |
ravisaralaya@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
SR Ravikiran |
| Designation |
|
| Affiliation |
|
| Address |
Assistant Professor, Department of Pediatrics
KVG Medical College
Not Applicable
N/A
574327
India |
| Phone |
9480238528 |
| Fax |
|
| Email |
ravisaralaya@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
SR Ravikiran |
| Designation |
|
| Affiliation |
|
| Address |
Assistant Professor, Department of Pediatrics
KVG Medical College
Not Applicable
N/A
574327
India |
| Phone |
9480238528 |
| Fax |
|
| Email |
ravisaralaya@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
SR Ravikiran |
| Address |
Associate Professor
Department of Pediatrics
KMC, Mangalore |
| Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SR Ravikiran |
Pediatrics Outpatient Department |
KVG Medical College,Kurunjibagh-574327
|
9480238528
ravisaralaya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To determine if acute pain response in newborns during administration of the BCG vaccine and the Hepatitis-B vaccine is affected by the order in which they are given. |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
BCG vaccine injection first followed by HepatitisB vaccine injection |
0.1 ml of BCG vaccine (TUBERVAC?) was administered intradermally at the convex aspect of the left shoulder using a tuberculin syringe first followed by HepatitisB vaccine |
| Comparator Agent |
HepatitisB vaccine injection first followed by Bcg vaccine injection |
0.5 ml of Hepatitis B vaccine (GeneVac-B?) was administered intramuscularly at the anterolateral aspect of thigh using 0.60X25mm (23X1) needle followed by BCG vaccine |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Randomized study of full term healthy newborns who received the routine dose of BCG and the Hepatitis-B vaccine in the vaccination room of Pediatric Department; KVG Medical College Hospital; Sullia. |
|
| ExclusionCriteria |
| Details |
We excluded sick newborns , 5 minute APGAR<7, low birth weight babies, and those who were discharged before the weekly vaccination day. |
|
Method of Generating Random Sequence
Modification(s)
|
Random Number Table |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The primary outcome measure was the neonatal pain. Pain assessment was done using the neonatal infant pain scale (NIPS). |
it was measured prior to the vaccine injections and during the vaccine injections. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 10-cm visual analog scale (VAS) |
Obtained immediately after the first and second vaccine injections. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
06/05/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
06/05/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Pain response in newborns to the order of injecting BCG and Hepatitis-B vaccines: a randomized trial.
Ravikiran SR, Kumar PM, Meundi AD.
Indian J Pediatr. 2011 Jun;78(6):693-7. doi: 10.1007/s12098-010-0327-3. Epub 2010 Dec 31. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a Single-center, randomized, parallel group, active controlled trial to determine if acute pain response after administration of the BCG vaccine and the Hepatitis-B vaccine is affected by the order in which they are given. Setting: Vaccination room in the Pediatrics Outpatient Department at KVG Medical College; Karnataka, India. Participants: Healthy term neonates undergoing routine immunization. Interventions: Newborns received either BCG vaccine or the Hepatitis-B vaccine first, followed by the other vaccine. Main Outcome Measures: The primary outcome was neonatal pain during vaccine injection as assessed by a validated measure, the Neonatal Infant Pain Scale (NIPS), scored by resident doctors blinded to the study purpose and hypothesis. In addition, a nurse rated pain using a 10-cm visual analog scale (VAS). |