Trial Outcomes & Findings for Comparison of Breast Feeding Counseling and Video Demonstration on Exclusive Breast Feeding Rates at 6 Weeks (NCT NCT00983489)
NCT ID: NCT00983489
Last Updated: 2013-05-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1411 participants
Primary outcome timeframe
6 weeks
Results posted on
2013-05-24
Participant Flow
January 2009 to June 2010 Tertiary care neonatal unit
None excluded after enrolment. Those who did not follow up were not analysed.
Participant milestones
| Measure |
Counselling
counselling: Breast feeding counselling will be done to mothers
|
Video Demonstration
Video demonstration to mothers on the advantages of exclusive breast feeding
|
Standard Care
Standard care includes the routine care provided to the neonates as per hospital protocol
|
|---|---|---|---|
|
Overall Study
STARTED
|
511
|
453
|
447
|
|
Overall Study
COMPLETED
|
326
|
168
|
135
|
|
Overall Study
NOT COMPLETED
|
185
|
285
|
312
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Breast Feeding Counseling and Video Demonstration on Exclusive Breast Feeding Rates at 6 Weeks
Baseline characteristics by cohort
| Measure |
Counselling
n=511 Participants
counselling: Breast feeding counselling will be done to mothers
|
Video Demonstration
n=453 Participants
Video demonstration to mothers on the advantages of exclusive breast feeding
|
Standard Care
n=447 Participants
Standard care includes the routine care provided to the neonates as per hospital protocol
|
Total
n=1411 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
23.7 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
23.9 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
24.3 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
24.0 years
STANDARD_DEVIATION 3.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
243 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
677 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
268 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
734 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
511 participants
n=5 Participants
|
453 participants
n=7 Participants
|
447 participants
n=5 Participants
|
1411 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Counselling
n=326 Participants
counselling: Breast feeding counselling will be done to mothers
|
Video Demonstration
n=168 Participants
Video demonstration to mothers on the advantages of exclusive breast feeding
|
Standard Care
n=135 Participants
Standard care includes the routine care provided to the neonates as per hospital protocol
|
|---|---|---|---|
|
Exclusive Breast Feeding Rate at Six Weeks Postnatal Age
|
271 Participants
|
117 Participants
|
97 Participants
|
Adverse Events
Counselling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Video Demonstration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Kanchan Sharma
Deen Dayal Upadhaya Hospital, New Delhi
Phone: 919417938224
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place