Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial
Recruitment status was Recruiting
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| First Received Date ICMJE | October 20, 2008 | ||||||||
| Last Updated Date | October 20, 2008 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To determine the effect of delivery room Skin To Skin contact on breast feeding behaviour of term neonates born by normal vaginal delivery, between 36-48 hours by video recording. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA) [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial | ||||||||
| Official Title ICMJE | Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial | ||||||||
| Brief Summary | Aims and Objectives Aim To determine the effect of delivery room Skin To Skin contact on breast feeding behavior of term neonates born by normal vaginal delivery at 36-48 hours. Objectives Primary objective To determine the effect of delivery room Skin To Skin contact on breast feeding behaviour of term neonates born by normal vaginal delivery, between 36-48 hours (as measured by Infant Breast Feeding Score) by video recording using a randomized controlled design. Secondary objectives To determine the effect of delivery room Skin to Skin contact on
Hypothesis Infants receiving skin to skin contact when compared with neonates not receiving it, demonstrate better breast feeding behaviour. |
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| Detailed Description | Inclusion and exclusion criteria for the enrollment of subjects in the study Inclusion criteria Term babies born to mothers by normal vaginal delivery in the study period. Exclusion criteria
Outcome Measures:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Breastfeeding | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Thukral A, Sankar MJ, Agarwal R, Gupta N, Deorari AK, Paul VK. Early skin-to-skin contact and breast-feeding behavior in term neonates: a randomized controlled trial. Neonatology. 2012;102(2):114-9. doi: 10.1159/000337839. Epub 2012 Jun 14. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | June 2009 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | India | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00776789 | ||||||||
| Other Study ID Numbers ICMJE | dranuthukral | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Anu Thukral, AIIMS | ||||||||
| Study Sponsor ICMJE | All India Institute of Medical Sciences, New Delhi | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | All India Institute of Medical Sciences, New Delhi | ||||||||
| Verification Date | August 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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