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

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ClinicalTrials.gov Identifier: NCT00776789
Recruitment Status : Completed
First Posted : October 21, 2008
Results First Posted : February 27, 2014
Last Update Posted : February 27, 2014
Sponsor:
Information provided by (Responsible Party):
Anu Thukral, All India Institute of Medical Sciences, New Delhi

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Breastfeeding
Interventions: Other: skin to skin contact
Other: Control group

  Participant Flow

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

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 
Overall Participants Analyzed 
[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) 
[1] gestation age in weeks
Gender 
[Units: Participants]
 		     
Female   10   8   18 
Male   10   13   23 


  Outcome Measures

1.  Primary:   The Median Breast Feeding Score   [ Time Frame: 36-48 hours by video recording ]
  Show Outcome Measure 1

2.  Secondary:   Salivary Cortisol   [ Time Frame: 6 hours ]
  Show Outcome Measure 2

3.  Secondary:   Breast Feeding Status at 48 Hours   [ Time Frame: 48 hours ]
  Show Outcome Measure 3

4.  Secondary:   Breast Feeding Status at 6 Weeks   [ Time Frame: 6 weeks ]
  Show Outcome Measure 4


  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
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

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
First Submitted: October 20, 2008
First Posted: October 21, 2008
Results First Submitted: June 1, 2010
Results First Posted: February 27, 2014
Last Update Posted: February 27, 2014