| CTRI Number |
CTRI/2013/06/003720 [Registered on: 05/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
04/06/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [effect of skin to skin contact on breastfeeding with newborn and mother] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study effect of Early Skin-to-Skin Contact on Exclusive Breastfeeding at 6 weeks of age in Healthy Term Neonates born by Vaginal Delivery. |
|
Scientific Title of Study
|
Efficacy of Early Skin-to-Skin Contact on Rate of Exclusive Breastfeeding at 6 weeks of age in Healthy Term Neonates born by Vaginal Delivery: A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
amit sharma |
| Designation |
post graduate student |
| Affiliation |
Department of pediatrics, government medical college chandigarh |
| Address |
C/O Dr Deepak Chawla
MD (Pediatrics), DM (Neonatology)
Associate Professor
Department of Pediatrics
Government Medical College and Hospital
Sector 32,India
department of pediatrics, 4th floor block D, government medical college, sector 32 chandigarh , India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121559 |
| Fax |
0172-2608488 |
| Email |
dramit55555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Chawla |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
department of pediatrics government medical college and hospital sector 32 chandigarh INDIA |
| Address |
Dr Deepak Chawla
MD (Pediatrics), DM (Neonatology)
Associate Professor
Department of Pediatrics
Government Medical College and Hospital
Sector 32, Chandigarh 160 030, India
department of pediatrics, 4th floor block D , government medical college , sector 32 chandigarh , India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121559 |
| Fax |
0172-2608488 |
| Email |
drdeepak.chawla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Chawla |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
. |
| Address |
Dr Deepak Chawla
MD (Pediatrics), DM (Neonatology)
Associate Professor
Department of Pediatrics
Government Medical College and Hospital
Sector 32, Chandigarh 160 030, India
.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121559 |
| Fax |
0172-2608488 |
| Email |
drdeepak.chawla@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of pediatrics, government medical college, sector 32, Chandigarh, UT |
|
|
Primary Sponsor
|
| Name |
department of pediatrics government medical college sector chandigarh |
| Address |
Department of Pediatrics, 4th floor , Block D
Government Medical College and Hospital
Sector 32, Chandigarh 160 030, India |
| Type of Sponsor |
Government 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 Deepak Chawla |
Department of pediatrics ,Government medical college , sector 32, Chandigarh ,UT |
Department of pediatrics , 4th floor, Block D, Government medical college , sector 32, Chandigarh , UT
Chandigarh
CHANDIGARH |
9646121559
drdeepak.chawla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| government medical college sector 32 chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Term Neonates born by Vaginal Delivery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
early skin to skin contact |
Early Skin to skin is placing of the naked baby prone on the mothers bare chest soon after birth |
| Comparator Agent |
standard care |
neonate was placed under a radiant warmer while its mother was undergoing active management of third stage of labor and repair of episiotomy. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Neonates born at term gestation by vaginal delivery and not requiring initial steps as per Neonatal Resuscitation Algorithm of American Academy of Pediatrics-American Heart Association |
|
| ExclusionCriteria |
| Details |
Neonates with major congenital malformations, product of multiple pregnancies, known HIV-seropositive mother, any contraindication for breastfeeding and inability to come for follow up at 6 weeks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome of the study was efficacy of early skin to skin contact on rate of exclusive breastfeeding at 6 weeks of postnatal age. |
Primary outcome of the study was efficacy of early skin to skin contact on rate of exclusive breastfeeding estimated at 6 weeks of postnatal age. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect of early skin to skin contact on the maternal pain during episiotomy repair |
within 45 minutes of birth of neonate |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This prospective, open label, randomized controlled trial was conducted at a teaching hospital in north India to evaluate efficacy of early and brief skin to skin contact on the rate of exclusive breastfeeding at 6 weeks of age . Early initiation of breastfeeding has been shown to reduce neonatal mortality by one-fourth. However, in India only about one-fourth neonates get first breastfeeding within one hour of birth and less than half are exclusive breastfed at six months of age. In addition to providing warmth, it facilitates attachment to the breast and improves bonding/attachment. Early Skin to Skin to contact, placing of the naked baby prone on the mother’s bare chest soon after the birth has been has been recommended as an important component of the care immediately after birth and is included as a requirement in World Health Organisation/ United Nations children’s fund (WHO/UNICEF) Baby Friendly Hospital Initiative (BFHI). Extended and uninterrupted early mother-infant contact after birth has been identified as a factor influencing effective sucking at the breast. In a systematic review, early Skin to Skin Contact was observed to increase rate of exclusive breastfeeding and breastfeeding duration. However, need of further studies was highlighted in the view of poor methodological quality of previous clinical trials and heterogeneity in reported outcomes. We planned this study to evaluate efficacy of early and brief skin to skin contact on rate of exclusive breastfeeding at 6 weeks of age. |