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

Breastfeeding Clinical Trial

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

Status Completed

Clinical Trial 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

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breastfeeding

• NCT number: NCT00776789
• Study type: Interventional
• Source: All India Institute of Medical Sciences, New Delhi
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Completion date: June 2009