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Comparison of Breast Feeding Counseling and Video Demonstration on Exclusive Breast Feeding Rates at 6 Weeks

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ClinicalTrials.gov Identifier: NCT00983489
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : May 24, 2013
Last Update Posted : May 24, 2013
Sponsor:
Information provided by (Responsible Party):
Dr Kanchan Sharma, Deen Dayal Upadhyay Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Exclusive Breast Feeding
Interventions: Behavioral: video demonstration
Behavioral: counselling

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
January 2009 to June 2010 Tertiary care neonatal unit

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None excluded after enrolment. Those who did not follow up were not analysed.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Counselling   Video Demonstration   Standard Care
STARTED   511   453   447 
COMPLETED   326   168   135 
NOT COMPLETED   185   285   312 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Counselling   Video Demonstration   Standard Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 511   453   447   1411 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.7  (3.2)   23.9  (3.8)   24.3  (3.6)   24.0  (3.5) 
Gender 
[Units: Participants]
       
Female   243   215   219   677 
Male   268   238   228   734 
Region of Enrollment 
[Units: Participants]
       
India   511   453   447   1411 


  Outcome Measures

1.  Primary:   Exclusive Breast Feeding Rate at Six Weeks Postnatal Age   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Kanchan Sharma
Organization: Deen Dayal Upadhaya Hospital, New Delhi
phone: 919417938224
e-mail: psaiims@yahoo.co.in



Responsible Party: Dr Kanchan Sharma, Deen Dayal Upadhyay Hospital
ClinicalTrials.gov Identifier: NCT00983489     History of Changes
Other Study ID Numbers: ddu001
First Submitted: September 22, 2009
First Posted: September 24, 2009
Results First Submitted: April 5, 2013
Results First Posted: May 24, 2013
Last Update Posted: May 24, 2013