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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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.
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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

1.  Primary:

The Median Breast Feeding Score   [ Time Frame: 36-48 hours by video recording ]

2.  Secondary:

Salivary Cortisol   [ Time Frame: 6 hours ]

3.  Secondary:

Breast Feeding Status at 48 Hours   [ Time Frame: 48 hours ]

4.  Secondary:

Breast Feeding Status at 6 Weeks   [ Time Frame: 6 weeks ]

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.