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

All India Institute Of Medical Science (AIIMS)

Status: Completed

Conditions: Breastfeeding

Treatments: Other: skin to skin contact; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT00776789

dranuthukral

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

skin to skin contact

Experimental group

Description:

Infants randomized to this group were placed prone over the mother's chest immediately after birth. Skin-to-skin contact was continued for the next two hours. Mothers in both the groups received support for initiating breastfeeding, if required. All mothers, regardless of the group allocation, were advised to give exclusive breastfeeding to their infants during the hospital stay. They were discouraged from giving supplemental feeds to their infants unless indicated by the duty registrar. All the mothers were counseled regarding the duration of exclusive breastfeeding at the time of discharge.

Treatment:

Other: skin to skin contact

Control group

Experimental group

Description:

The infants who were allocated to the conventional care (control group) were kept by the mother's side and did not receive early SSC. All mothers, regardless of the group allocation, were advised to give exclusive breastfeeding to their infants during the hospital stay. They were discouraged from giving supplemental feeds to their infants unless indicated by the duty registrar. All the mothers were counseled regarding the duration of exclusive breastfeeding at the time of discharge.

Treatment:

Other: Control group