| CTRI Number |
CTRI/2014/07/004724 [Registered on: 10/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
22/05/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of breastfeeding and 25% oral dextrose for pain relief during immunization of infants |
|
Scientific Title of Study
|
Comparison of breastfeeding and 25% oral dextrose for pain relief during immunization of infants: a randomized controlled trial |
| Trial Acronym |
BFODPR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIVEDITA MOHAN |
| Designation |
MEDICAL STUDENT |
| Affiliation |
MOSC MEDICAL COLLEGE |
| Address |
BATCH OF 2011
MOSC MEDICAL COLLEGE
KOLENCHERY, KOCHI
ERNAKULAM DISTRICT
KERALA
MOSC MEDICAL COLLEGE
KOLENCHERY, KOCHI
ERNAKULAM DISTRICT
KERALA
PIN 682311
Ernakulam
KERALA
682311
India |
| Phone |
9746023125 |
| Fax |
4843055630 |
| Email |
niveditapm@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANNA MATHEW |
| Designation |
PROFESSOR RESEARCH COORDINATOR |
| Affiliation |
MOSC MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PHARMACOLOGY
MOSC MEDICAL COLLEGE
KOLENCHERY, KOCHI
ERNAKULAM DISTRICT
KERALA
MOSC MEDICAL COLLEGE
KOLENCHERY, KOCHI
ERNAKULAM DISTRICT
KERALA
PIN 682311
Ernakulam
KERALA
682311
India |
| Phone |
9442221950 |
| Fax |
4843055630 |
| Email |
350south@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANNA MATHEW |
| Designation |
PROFESSOR RESEARCH COORDINATOR |
| Affiliation |
MOSC MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PHARMACOLOGY
MOSC MEDICAL COLLEGE
KOLENCHERY, KOCHI
ERNAKULAM DISTRICT
KERALA
MOSC MEDICAL COLLEGE
KOLENCHERY, KOCHI
ERNAKULAM DISTRICT
KERALA
PIN 682311
Ernakulam
KERALA
682311
India |
| Phone |
9442221950 |
| Fax |
4843055630 |
| Email |
350south@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR STS ID NO 2014-01468 |
|
|
Primary Sponsor
|
| Name |
MOSC MEDICAL COLLEGE |
| Address |
MOSC MEDICAL COLLEGE
KOLENCHERY, KOCHI
ERNAKULAM DISTRICT
KERALA
PIN 682311 |
| Type of Sponsor |
Private 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 ABRAHAM PAULOSE |
MOSC MEDICAL COLLEGE |
IMMUNIZATION CLINIC
DEPAERTMENT OF PEDIATRICS
MOSC MEDICAL COLLEGE
KOLENCHERY
KOCHI
ERNAKULAM DISTRICT
KERALA
PIN 682311
Ernakulam
KERALA |
9495037152
4843055630
drabrahampaulose@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MOSC MEDICAL COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
comparison of pain relief with breastfeeding and 25% dextrose during immunization with pentavalent vaccine in healthy infants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Breastfeeding |
breastfeeding for 2 minutes prior to and during immunization with pentavalent vaccine in healthy infants below 6 months of age. |
| Intervention |
Oral 25% dextrose |
2ml 25% dextrose orally given 2 minutes before immunization with pentavalent vaccine in healthy infants below 6 months of age. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
Healthy infants born at 37 to 42 weeks of gestation, with birth weight 2.5 kilos or more.
Exclusively or partially breastfed, attending immunization clinic of this institution for primary vaccination with pentavalent vaccine.
All infants will be fed within 3 hours and over 30 minutes prior to the intervention. |
|
| ExclusionCriteria |
| Details |
Infants with current illness.
Unable to tolerate fluids by mouth.
Cerebral palsy where response to pain stimuli may be altered.
History of perinatal asphyxia.
Congenital malformations and developmental delay. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acute behavioral pain response assessed using a composite score obtained from the Face Legs Activity Cry Consolability(FLACC)Scale for infants |
The FLACC Score will be calculated immediately,and after 1 and 3 minutes of needle insertion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/05/2014 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open label, parallel group, single centre trial, comparing the efficacy of breastfeeding and 25% oral dextrose for pain relief during immunization with pentavalent vaccine in healthy infants. Infants will be randomized by computer generated permuted block randomization into one of two groups: group A- Breastfeeding (40 infants). Group B- 25% dextrose (40 infants) after receiving written informed consent from the mother. Allocation concealment will be acheived using sequentially numbered opaque sealed envelopes. Demographic data of infants will be collected. In the breastfeeding group, infants will be breastfed throughout the intervention, starting two minutes prior to the vaccination. In group B, infants will receive 2ml 25% dextrose solution orally, with the help of a sterile syringe, 2 minutes before the vaccination. A qualified nurse practitioner will prepare the infant and administer the pentavalent vaccine.The outcome variable will be the acute behavioral pain response assessed using the FLACC Scale, immediately, and after 1 and 3 minutes of needle insertion. The assessment will be done by the primary investigator.
|