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Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anu Thukral, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00776789
First received: October 20, 2008
Last updated: January 10, 2014
Last verified: January 2014
History of Changes
Results First Received: June 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Breastfeeding
Interventions: Other: skin to skin contact
Other: Control group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Skin to Skin Contact Babies in this arm will be given skin to skin contact for at least 2 hours after birth
Control Group baby will be kept by the mothers side and not given skin to skin contact

Participant Flow:   Overall Study
    Skin to Skin Contact     Control Group  
STARTED     20     21  
COMPLETED     17     18  
NOT COMPLETED     3     3  
Consent refusal                 2                 2  
Poor quality video                 1                 1  



  Baseline Characteristics
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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
Skin to Skin Contact Babies in this arm will be given skin to skin contact for at least 2 hours after birth
Control Group baby will be kept by the mothers side and not given skin to skin contact
Total Total of all reporting groups

Baseline Measures
    Skin to Skin Contact     Control Group     Total  
Number of Participants  
[units: participants]
 		  20     21     41  
Age  
[units: participants]
 		     
<=18 years     20     21     41  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age [1]
[units: weeks]
Mean (Standard Deviation) 		  38  (0.91)     38  (1.2)     38  (0.98)  
Gender  
[units: participants]
 		     
Female     10     8     18  
Male     10     13     23  
[1] gestation age in weeks



  Outcome Measures
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1.  Primary:   The Median Breast Feeding Score   [ Time Frame: 36-48 hours by video recording ]
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2.  Secondary:   Salivary Cortisol   [ Time Frame: 6 hours ]
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3.  Secondary:   Breast Feeding Status at 48 Hours   [ Time Frame: 48 hours ]
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4.  Secondary:   Breast Feeding Status at 6 Weeks   [ Time Frame: 6 weeks ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
This study evaluated breast feeding behaviour of term neonates with only one video, which may not have been an accurate marker of feeding behavior.There could a possibility of inadvertent bias at the time of intervention.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Anu Thukral
Organization: AIIMS
phone: 01126594605
e-mail: dranuthukral@yahoo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Anu Thukral, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT00776789     History of Changes
Other Study ID Numbers: dranuthukral
Study First Received: October 20, 2008
Results First Received: June 1, 2010
Last Updated: January 10, 2014
Health Authority: India: Indian Council of Medical Research