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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00776789
First received: October 20, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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

  1. Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA)
  2. Weight at 48 hours as measured by digital infant weighing scale.
  3. Maternal perception of breast milk output, breast consistency, infant's feeding and activity at 36-48 hours as measured by a score graded as very satisfied, satisfied, acceptable and not satisfied.
  4. Number and duration of feeding sessions till 48 hrs according to the mother as assessed at 48 hours
  5. Breast feeding rates at 6 weeks measured at the time of vaccination at the time of visit to the hospital for the same or as asked by telephonic conversation.

Hypothesis

Infants receiving skin to skin contact when compared with neonates not receiving it, demonstrate better breast feeding behaviour.


Condition Intervention
Breastfeeding
 Other: skin to skin contact
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding
U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: skin to skin contact
Babies in this arm will be given skin to skin contact for at least 2 hours after birth
 Other: skin to skin contact
Babies in this arm will be given skin to skin contact for at least 2 hours after birth
Other Name: Skin to skin contact
Experimental: 2
baby will be kept by the mothers side and not given skin to skin contact
 Other: Placebo
baby will be kept by the mothers side only
Other Name: Placebo

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

  1. Babies with major congenital malformation.
  2. Multiple pregnancy
  3. Babies requiring resuscitation beyond the initial steps
  4. Babies requiring care in the neonatal intensive care unit.

  5. Maternal problems requiring immediate care

    • Severe preeclampsia defined as Blood pressure more than 160/110, Proteinuria more than 3+, Oliguria less than 500 ml, Pulmonary edema, cerebral visual disturbances, Impaired liver function, Thrombocytopenia, Epigastric Pain
    • Imminent eclampsia
    • Severe bleeding
    • Mother with significant surgical or medical illness requiring separation of the baby from the mother.
  6. Small for dates and large for dates babies
  7. Infants of diabetic mother
  8. Maternal refusal of consent

Outcome Measures:

  1. Measurement of Breast feeding Behavior at 36-48 hours using Infant Breast feeding Behavior scale
  2. Salivary Cortisol
  3. Weight at birth
  4. Weight at 48 hours
  5. Number of feeding sessions till 48 hours
  6. Maternal Perception of Infant activity, feeding and breast milk output.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term babies born to mothers by normal vaginal delivery in the study period.

Exclusion Criteria:

  1. Babies with major congenital malformation.
  2. Multiple pregnancy
  3. Babies requiring resuscitation beyond the initial steps
  4. Babies requiring care in the neonatal intensive care unit.

  5. Maternal problems requiring immediate care

    • Severe preeclampsia defined as Blood pressure more than 160/110, Proteinuria more than 3+, Oliguria less than 500 ml, Pulmonary edema, cerebral visual disturbances, Impaired liver function, Thrombocytopenia, Epigastric Pain
    • Imminent eclampsia
    • Severe bleeding
    • Mother with significant surgical or medical illness requiring separation of the baby from the mother.
  6. Small for dates and large for dates babies
  7. Infants of diabetic mother
  8. Maternal refusal of consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776789

Contacts
Contact: anu - Thukral, MD +91-9891392188 ext - dranuthukral@yahoo.com
Contact: satish - Mishra, DM +91-9868607208 ext - drmishrasatish@gmail.com

Locations
India
AIIMS Recruiting
New Delhi, Delhi, India, 110029
Contact: anu - thukral, MD     +91-9891392188 ext -     dranuthukral@yahoo.com    
Contact: Satish - Mishra, DM     +91-9868607208 ext -     drmishrasatish@gmail.com    
Principal Investigator: Anu - Thukral, MD            
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Study Director: Vinod Kr Paul, MD All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided by All India Institute of Medical Sciences, New Delhi

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

Responsible Party: Anu Thukral, AIIMS
ClinicalTrials.gov Identifier: NCT00776789     History of Changes
Other Study ID Numbers: dranuthukral
Study First Received: October 20, 2008
Last Updated: October 20, 2008
Health Authority: India: Indian Council of Medical Research

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Skin to skin contact
Salivary cortisol
Breast feeding Behavior

ClinicalTrials.gov processed this record on May 16, 2013