Clinical trial NCT00776789: Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial
Official title: Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Skin to skin contact
Salivary cortisol
Breast feeding Behavior
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2008-10-21
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

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 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.

Primary outcomes:
measure: The Median Breast Feeding Score
timeFrame: 36-48 hours by video recording
Secondary outcomes:
measure: Salivary Cortisol
timeFrame: 6 hours
measure: Breast Feeding Status at 48 Hours
timeFrame: 48 hours
measure: Breast Feeding Status at 6 Weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: AIIMS
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Vinod Kr Paul, MD
role: STUDY_DIRECTOR
References:
citation: 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.